Careers

Full time positions offer medical, dental, vision and life insurance, profit sharing, retirement plan, paid sick leave, paid vacation and other ancillary compensations.

To apply for any of these positions listed below, send your resume and contact information:

Human Resources Department

hr_dept@biocare.net or fax to: 925-603-8075

Please find a list of positions (if available) below:

Careers

Manager Protein Chemistry

Job Description
The Manager Protein Chemistry manages all activities for tactical execution of the conjugation of antibodies for both established products and current research in a matter that meets the needs of ongoing production, under Good Manufacturing Practices.

Reports to: Vice President, Research and Development

Essential Functions 

  1. Manage polymer production activities
    a. Polymer scheduling, production, QC testing, and transfers to Manufacturing
    b. Ensure supply of raw materials used for the production of polymers
    c. Antibody labeling for R&D and Manufacturing needs
    d. Responsible that all existing and new Work Instructions, Forms, and Procedures are up-to-date and in compliance with the company’s Quality System
    e. Supports Continuous Process Improvement activities in Protein Chemistry and other departments
  2. Administration/Compliance functions
    a. Manage day to day activities
    b. Follow procedures for ordering and receiving raw materials to be used in a GMP environment
    c. Responsible for ensuring inventory is up-to-date and all expired materials are properly disposed
    d. Work with appropriate departments to maintain instrument calibration, maintenance and compliance
    e. Ensure instrument logs are properly filled out and submitted to QA
    f. Assist QA with CAPAs, Deviation Reports and other Quality System documentation
    g. Make certain batch records are complete and properly documented prior to submitting to QA
    h. In charge of ensuring all personnel and lab safety policies are strictly adhered to as required by the company’s EH&S department
  3. Quality Control Functions
    a. Ensure that ELISA’s on all dilute polymers produced in manufacturing are performed in a timely manner and all documentation is correct prior to QA submission
    b. Ensure all Polymers and antibody raw materials produced in the Protein Chemistry Department are qualified by ELISA testing according to established procedures
    c. Coordinate with Reagent R&D for IHC testing of Polymers and other products produced in Protein Chemistry
  4. Departmental Collaboration
    a. Work closely with Manufacturing, Reagent R&D, and QA personnel to troubleshoot and mitigate material failure risks
    b. Participate in meetings where chemistry and protein chemistry and manufacturing expertise is required
    c. Formulate solutions, manufacture buffers and supply R&D with protein materials to support ongoing and new product ventures
  5. Supervises Protein Chemistry department staff
    a. Coach, train, and mentor
    b. Oversees department staff professional development goals
    c. Participates in monthly/quarterly manager trainings and seminars
  6. Familiar with GMP, FDA and ISO Regulations.
  7. Proven experience working in a cross functional team.

Competencies

  1. Experience working in a supervisory role in a GMP and FDA regulated manufacturing environment.
  2. Expert in antibody labeling especially Horseradish Peroxidase, Alkaline Phosphatase, and other labeling techniques (e.g. biotin, fluorescent dyes, Digoxigenin).
  3. Proven expertise in development and optimization of monoclonal and polyclonal antibody (and antibody fragment) methods.
  4. Proficient with characterization of proteins by physical and functional methods.
  5. Experience with AKTA or other protein purification systems.
  6. Proven leadership/supervisory skills with strong ethics and attention to detail.
  7. Able to write and speak in English.
  8. Proficient in Microsoft Office Suite applications as required to perform job functions.
  9. Familiarity with GMP, FDA and ISO Regulations.

Supervisory Responsibility
This position manages all employees in the Protein Chemistry Group and is responsible for the performance management of employees within that group.

Work Environment
This job operates in a professional laboratory environment. The employee will be required to work with hazardous and non-hazardous chemicals. Standard office equipment such as phones, computers and printers will be used. In addition, this person will be required to use instrumentation such as balances, pipettes, chromatography, filtration, and centrifugation equipment.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hand to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear; and taste or smell. The employee must occasionally lift or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are 8:30 a.m. to 5:30 p.m. Monday – Friday unless otherwise determined by departmental needs that may include earlier or later starting and ending hours. This position may require extended weekday or weekend hours depending on business needs.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Less than 10% travel is required.

Required Education and Experience
Bachelor’s degree with a minimum of 7 years of experience or Master’s or PhD degree with 5-7 years of experience in Protein Biochemistry, Biology, Biochemistry or a related field working in a GMP and FDA regulated manufacturing environment.

AAP/EEO Statement
Biocare Medical is an Equal Opportunity Employer.

Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Line Clearance Inspector

Job Description
Responsible for performing Line Clearance activities at each phase of the manufacturing process.

Reports to: Manager, Quality Engineering

Essential Functions 
1. Ensures all documentation pertinent to each facet of the manufacturing process is available at the line prior to line clearance activities.
2. Performs a thorough review of manufacturing documentation to ensure compliance to department process.
3. Utilizes the Shelf-Life List in Document Changes during Line Clearance activities to ensure the expiry date given is reflective of what is called for in the list.
4. Reviews product packaging labels to ensure information is accurate to the product being assembled i.e., Part Number, Lot Number, Expiration Date, Storage conditions, Product Description, Product Class (IVD, RUO, ASR) and ensures all pertinent symbols are present i.e., hourglass, thermometer etc.
5. Utilizes the Master List of Bottles, Tips and Caps to ensure the material being used is approved for the product being processed.
6. Reviews process documentation to ensure the revision being used is reflective of what is found in Document Changes and that all information is accurate i.e., Part Number, Lot Number, Expiration Date and is signed as appropriate by the technician performing the task.
7. Responsible for ensuring the appropriate data sheet is printed and utilized by confirming the document at the line is of the same revision as that in Document Changes.
8. Ensures all material at the line at point of line clearance is reflective of the product being processed i.e., correct stock solution, labels, data sheets, documents and all packaging material i.e., bottles, tips, caps, bags, platforms, boxes etc.
9. Other duties as assigned by Management.

Competencies
1. High-level of reading comprehension.
2. Proof of at least one FDA EUA approved Vaccination for Covid-19 required. (Subject to reasonable accommodation)
3. Must be able to write clear, understandable documentation with effective presentation of information.
4. Demonstrates independent judgment within broadly defined policies and practices in resolving problems and making recommendations.
5. Basic computer literacy required.
6. Working knowledge of FDA/GMP/ISO.
7. Ability to work in a high-pressured deadline-oriented environment.
8. Understanding of basic math principles required.

Supervisory Responsibility
This position requires no supervisory responsibility.

Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as a desktop computer and smartphone. The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes. The worker is subject to noise. There is sufficient noise to cause the worker to shout in order to be heard above ambient noise level. The worker is subject to vibration. Exposure to oscillating movements of the extremities or whole body. The worker is subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, exposure to high heat or exposure to chemicals. The worker is subject to atmospheric conditions. One or more of the following conditions that affect the respiratory system of the skin: fumes, odors, dust, mists, gases, or poor ventilation. The worker is required to function in narrow aisles or passageways.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is required to climb: Ascending or descending stairs and the like, using feet and legs and/or hands and arms. Body agility is emphasized. Balance: Maintaining body equilibrium to prevent falling and walking, standing, or crouching. Stoop: Bending body downward and forward by bending spine at the waist. Kneel: Bending legs at knee to come to a rest on knee or knees. Crouch: Bending the body downward and forward by bending leg and spine. Crawl: Moving about on hands and knees or hands and feet. Reach: Extending hand(s) and arm(s) in any direction. Stand: Particularly for sustained periods of time. Walk: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. Push: Using upper extremities to press against something with steady force in order to thrust forward, downward, or outward. Pull: Using upper extremities to exert force in order to draw, haul or tug objects in a sustained motion. Lift: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling. Grasp: Applying pressure to an object with the fingers and palm. Feel: Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips. Talk: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Hear: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound. Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or fingers. Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes. Specific vision abilities required for this job include close vision, distance vision, observation of color when looking under a microscope, color vision, peripheral vision, depth perception and ability to adjust and focus.

 

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Less than 10% travel is required.

Required Education and Experience
High School Diploma or GED required with two to five (2-5) years of experience in a GMP regulated facility.

AAP/EEO Statement
Biocare Medical is an Equal Opportunity Employer.

Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Mechanical Engineer

Job Description
Responsible for detailed mechanical design from concept to manufacturing of automated electromechanical instrumentation in a regulated environment. The position is responsible for creating and documenting designs that meet the function, cost, and reliability requirements, established in the design input documents. This position will involve both new product development and enhancement/resolution of existing products.

Reports to: Chief Commercial and Strategy Officer

Essential Functions 
1. Conceptualize, design, prototype, test, and document electromechanical instruments including robotic, fluidic, and thermal subsystems
2. Interface and collaborate with internal and external R&D team members on design and development tasks and projects
3. Troubleshooting, analyzing, and optimizing automated IVD instrumentation
4. Create and present design review documentation
5. Assess new and legacy designs from a function, cost, and reliability perspective
6. Provide inputs to project planning phases regarding sequence, efforts, and timelines of development tasks
7. Working with Sustaining Engineering, Purchasing, and Manufacturing teams on design transfers of designs
8. Participate in creation of Design History Documentation like Requirement Specification and Hazard Analysis

Competencies
1 Proficient SolidWorks user with 5+ years of experience using features for milling, turning, sheet metal, and tooling parts.
2 5+ year experience in creating SolidWorks assemblies (Constraints, Configurations, BOM, Movement Simulation).
3 Experience in using SolidWorks Simulation to perform structural Finite Element Analysis.
4 5+ year experience in creating complete technical drawings using SolidWorks, that meet a regulated environment standard.
4 Must be able to write clear, understandable documentation with effective presentation of information.
5 Ability to manage multiple tasks effectively and efficiently with attention to detail and good organizational skills.
6 Demonstrates independent judgment in resolving problems and making recommendation.
7 Experience in instrument architecture and making rational buy vs. build decisions.
8 Good verbal and written communication skills. 9 Basic understanding of GMP and its application to the job.

Supervisory Responsibility
This position requires no supervisory responsibility.

Work Environment
This job operates in a professional office, laboratory, or shop environment. This role routinely uses standard office equipment such as a desktop computers and smartphones. The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes. The worker is subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, exposure to high heat or exposure to chemicals.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is occasionally required to climb: Ascending or descending stairs and the like, using feet and legs and/or hands and arms. Body agility is emphasized. Stoop: Bending body downward and forward by bending spine at the waist. Kneel: Bending legs at knee to come to a rest on knee or knees. Crouch: Bending the body downward and forward by bending leg and spine. Crawl: Moving about on hands and knees or hands and feet. Reach: Extending hand(s) and arm(s) in any direction. Stand: Particularly for sustained periods of time. Walk: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. Push: Using upper extremities to press against something with steady force in order to thrust forward, downward, or outward. Pull: Using upper extremities to exert force in order to draw, haul or tug objects in a sustained motion. Lift: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling. Grasp: Applying pressure to an object with the fingers and palm. Feel: Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips. Talk: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Hear: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound. Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or fingers.
Medium work: Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.

The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Less than 10% travel is required.

Required Education and Experience
Bachelor of Science or higher degree in Mechanical Engineering with 5 to 8 years of design and development experience from which 3 or more years shall be in a regulated environment (Medical and/or Aerospace). Proven track record in bringing designs from concept all the way to manufacturing.

AAP/EEO Statement
Biocare Medical is an Equal Opportunity Employer.

Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Senior Manager, FISH R&D

Job Description
The Senior Manager, FISH R&D will perform routine research and development (R&D) activities and manage all activities for tactical execution of the daily operations of the fluorescence in situ hybridization (FISH) R&D laboratory. Senior Manager, FISH R&D will supervise FISH R&D personnel and manage day-to-day activities associated with research, design, and development of the Biocare probe portfolio. This position will also lead the strategic efforts in expanding Biocare’s Molecular portfolio beyond FISH probes.

Reports to: Vice President, Reagent Research and Development

Essential Functions 
1 Direct, train and manage with knowledge and expertise, all employees of the FISH R&D Department.
2 Provide input in regard to assay feasibility, assay development, optimization, sample testing, verification, and validation.
3 Plan and coordinate experiments, maintain timelines, and review data of FISH R&D personnel.
4 Responsible for troubleshooting R&D and Manufacturing related issues in a timely manner.
5 Supervise general laboratory maintenance, order lab supplies, oversee equipment validation/maintenance/timely repair as needed.
6 Directs and maintains all standard operating procedures, processes, manufacturing documents, inventory control, equipment, and records according to industry standards and regulations.
7 Support Sales and Marketing activities by providing technical expertise as required.
8 Serve as point-of-contact between laboratory and senior management; provide status reports on current projects.
9 Ensures that laboratory personnel are following established procedures as well as abiding by lab safety regulations.
10 Drafts new policies and procedures to support good laboratory practice and communicates them to the FISH R&D lab staff and/or additional appropriate departments.
11 Supports probe and ancillary reagent releases and updates by completing all necessary PDLC-related forms.
12 Performs FISH procedures and daily laboratory functions.
13 Performs projects requiring implementation of design files. Writes data sheets and interprets experimental testing results.
14 Attends seminars, webcasts and workshops as well as generate abstracts and publications.
15 Knowledgeable in imaging analysis algorithms.
16 Works independently with minimal guidance or supervision.
17 Reviews test forms and other user editable forms of fellow FISH R&D staff members as needed to ensure accuracy of documents prior to submission.
18 Proven experience working in a cross functional team.
19 Familiar with GMP, FDA and ISO Regulations.
20 Other duties as assigned.

Competencies
1 Highly organized and detail-oriented individual.
2 Critical thinker with the ability to solve problems efficiently and effectively.
3 Possesses effective verbal, written, and interpersonal communication skills.
4 High-level of assertiveness without aggressiveness.
5 Ability to resolve conflicts and prevent escalation.
6 Excellent cross-functional team participation skills.
7 Consistently displays a positive, customer-focused attitude and extends respect and courtesy toward Supervisors and peers.
8 Strong Cytogenetic background with a good theoretical and practical understanding of FISH.
9 Solid understating of general Molecular Biology techniques such as DNA Amplification, DNA Purification, DNA Isolation, DNA Sequencing, and Fluorescent DNA Labeling.
10 Familiarity with bacterial cultures and mini/maxi preps.
11 Knowledgeable in sterile technique practices.
12 Experience in manufacturing/quality control documentation, compliance, ISO and Good Manufacturing policies and procedures. Also, must be proficient in managing inventory, people, and resources. Extensive knowledge of computers and the ability to handle many things at a time is a must.

Supervisory Responsibility
This position manages all employees of the FISH R&D department and is responsible for the Performance Management and hiring of the employees within that department.

Work Environment
This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as laptop computers and smartphones in addition to commonly used Molecular Laboratory Equipment. The worker is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work.)

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is required to kneel: Bending legs at knee to come to a rest on knee or knees. Reach: Extending hand(s) and arm(s) in any direction. Stand: Particularly for sustained periods of time. Walk: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. Finger: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling. Grasp: Applying pressure to an object with the fingers and palm. Feel: Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips. Talk: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Hear: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound. Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or fingers. Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Less than 10% travel is required.

Required Education and Experience
A Bachelor’s Degree or higher with five to eight (5-8) years of experience in a Molecular/Cytogenetic Laboratory. Five to eight (5-8) years’ experience in a Management role in a related field; Three plus (3+) years industry experience in an IVD Regulated Environment preferred; Experience with transfer of IVD’s from Product Development to Manufacturing/Operations highly desired.

AAP/EEO Statement
Biocare Medical is an Equal Opportunity Employer.

Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Associate I, Protein Chemistry

Job Description
The Protein Chemistry Associate I will take an active role in material processing, reagent formulation, technical manufacturing, and in-process and/or final quality control of reagents for use as components of in-vitro diagnostic (IVD) products. Specifically, he/she is involved in bioconjugation, protein purification, and analytical characterization of complex bioconjugates as they relate to the development of tissue diagnostic products for cancer and infectious disease. This position requires the person to adhere to all current industry standard regulations.

Reports to: Manager, Protein Chemistry

Essential Functions 
1 Bioconjugate Production
   a. Purify Antibodies utilizing chromatography and filtration processes
   b. Manufacture Polymers utilizing chromatography and filtration processes
   c. Prepare reagents

2 Perform GMP Activities
   a. Follow SOP’s and other work instructions
   b. Perform line clearance and review batch records
   c. Order and receive materials for manufacturing events to ensure an uninterrupted supply of existing products
   d. Maintain raw material Inventory control
   e. Monitor equipment logs as required by the Company Quality System

3 Support QC Activities
   a. Perform ELISA testing for Protein Chemistry Bioconjugates and In-process Manufactured Polymers
   b. Validate raw materials

4 Support R&D/Other Departments
   a. Aides in providing technical support to R&D, QA, and Manufacturing personnel
   b. Assist in reagent preparation and new formulations

5 Laboratory Safety and Hygiene
   a. Observe and comply with all safety standards and procedures
   b. Keep personal and shared spaces clean
   c. Wash and sanitize all laboratory glassware, plastic ware, and other essential items

6 Other
   a. Maintain an up-to-date laboratory notebook and other departmental recordkeeping documents
   b. Additional tasks may be assigned as needed

7 Other duties as assigned by Management.

Competencies
1 Experience working in a laboratory environment including protein purification and characterization techniques.
2 Familiar with qualitative and quantitative analytical techniques including ELISA, Chromatography, Gel Electrophoresis.
3 Basic understanding of GMP procedures and Quality Systems in an FDA regulated environment.
4 Comfortable with using computer applications as required to perform job functions.
5 Strong work ethic and attention to detail.
6 Demonstrated good planning and time management skills.
7 Proficient with Microsoft Word, Excel, and PowerPoint.
8 Proficient in writing and communicating in English.

Supervisory Responsibility
This position requires no supervisory responsibility.

Work Environment
This job operates in a professional laboratory environment. The employee will be required to work with hazardous and non-hazardous chemicals. Standard office equipment such as phones, computers and printers will be used. In addition, this person will be required to use instrumentation such as balances, pipettes, chromatography, filtration, and centrifugation equipment. The worker is subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, or exposure to chemicals. The worker is subject to atmospheric conditions. One or more of the following conditions that affect the respiratory system of the skin: fumes, odors, dust, mists, gases, or poor ventilation.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is required to climb: Ascending or descending stairs and the like, using feet and legs and/or hands and arms. Body agility is emphasized. Balance: Maintaining body equilibrium to prevent falling and walking, standing, or crouching on narrow, and sometimes slippery surfaces. Stoop: Bending body downward and forward by bending spine at the waist. Kneel: Bending legs at knee to come to a rest on knee or knees. Crouch: Bending the body downward and forward by bending leg and spine. Crawl: Moving about on hands and knees or hands and feet. Reach: Extending hand(s) and arm(s) in any direction. Stand: Particularly for sustained periods of time. Walk: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. Push: Using upper extremities to press against something with steady force in order to thrust forward, downward, or outward. Pull: Using upper extremities to exert force in order to draw, haul or tug objects in a sustained motion. Lift: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling. Grasp: Applying pressure to an object with the fingers and palm. Feel: Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips. Talk: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Hear: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound. Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or fingers. Medium work: Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes. Specific vision abilities required for this job include close vision, distance vision, observation of color when looking under a microscope, color vision, peripheral vision, depth perception and ability to adjust and focus.

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5:00 p.m. This position may periodically require working longer hours.

Travel
Travel is not required for this position.

Required Education and Experience
Bachelor’s degree in a scientific field with one plus (1+) years’ experience working in Protein Chemistry, Biochemistry, Molecular Biology, or other related fields.

AAP/EEO Statement
Biocare Medical is an Equal Opportunity Employer.

Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Electrical and Mechanical Technician

Job Description
Responsible for the manufacturing of Biocare Medical’s laboratory instruments and administrative support.

Reports to:Manager, Instrument Manufacturing

Essential Functions

  1. Assembly of new and recertified production instruments:

a. Complete all instrument sub-assembly and final assembly requirements
b. Program all circuit boards, computer ports, printers, etc.
c. Calibrate instruments to required specifications
d. Flush, clean and package all completed assemblies
e. Fill daily sales orders

2. Complete required quality control checks and visual inspections.
3. Complete required device history record documentation.
4. Preform troubleshooting, if applicable, and document action(s) taken.

5. Maintain Raw Material inventory:
a. Pull parts for production in a FIFO (fist in first out) order
b. Assist with quarterly count efforts

6. Daily Clean-Up:
a. Put away all QA approved assemblies and label all WIP assemblies
b. Breakdown and throw out all cardboard boxes
c. Sweep manufacturing area floors and leave walkways clear
d. Wipe down workstations and tools as needed
e. Remove any clutter

7. Support other internal departments as approved by Manager, Instrument Manufacturing.
8. Assist with daily Manufacturing Orders (MO’s) in Biocare’s business system, Great Plains (GP).
9. Assist with department document updates: Standard Operating Procedures, Work Instructions, Assembly Forms and KPI’s.
10. Other duties as assigned by Management.

Competencies

  1. Ability to read and follow technical instructions and drawings.
  2. Proof of at least one FDA EUA approved Vaccination for Covid-19 required. (Subject to reasonable accommodation)
  3. Mechanical aptitude: possess the skills to assemble using hand and power tools.
  4. Understanding of Good Manufacturing Practices (GMP) and its application to the job.
  5. Ability to complete required production documentation.
  6. Basic computer skills with Word, Excel, and Outlook.
  7. Attention to detail and strong organizational skills.
  8. Ability to work in high-pressure, deadline-oriented environment.
  9. Ensures that all SOPs are followed and recommend Quality Improvement Measures.
  10. Accuracy and attention to detail.
  11. Familiarly with GMP, FDA and ISO regulations.

Work Environment
This job operates in both temperature-controlled labs and warehouse environments, with fluctuating temperatures. The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is required to climb: Ascending or descending stairs and the like, using feet and legs and/or hands and arms. Body agility is emphasized. Stoop: Bending body downward and forward by bending spine at the waist. Kneel: Bending legs at knee to come to a rest on knee or knees. Crouch: Bending the body downward and forward by bending leg and spine. Stand: Particularly for sustained periods of time. Walk: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. Push: Using upper extremities to press against something with steady force in order to thrust forward, downward, or outward. Pull: Using upper extremities to exert force in order to draw, haul or tug objects in a sustained motion. Lift: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. Grasp: Applying pressure to an object with the fingers and palm. Feel: Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips. Talk: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Hear: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound. Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or fingers. Medium work: Exerting up to 75 pounds of force occasionally, and/or up to 25 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes. The worker is required to have visual acuity to perform an activity such as: operates machines where the seeing job is at or within arm’s reach; performs mechanical or skilled trades tasks of a non-repetitive nature, such as technicians, mechanics, etc. The worker is required to have visual acuity to operate motor vehicles and/or heavy equipment. The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned. Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus.

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are 6:30 a.m. to 3:00 p.m. Monday – Friday unless otherwise determined by departments needs that may include earlier or later starting and ending hours. This position may require extended weekday or weekend hours depending on business needs.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Less than 10% travel is required.

Required Education and Experience
High School Diploma or GED required, Associate Degree or higher in technical field or trade school preferred.
Two plus (2+) years’ experience with Electrical/Electronic and Mechanical Systems required.
Two plus (2+) years’ experience working in ISO/GMP environment preferred.

Antibody Qualification Associate, Technology Development

Job Description
The Antibody Qualification Associate functions with minimal supervision and guidance within the research and development (R&D) laboratory. Antibody Qualification Associate performs R&D activities on new and existing products involving Histology and Immunohistochemistry (IHC) procedures within well-defined guidelines. Antibody Qualification Associate keeps abreast of current methodologies and developments within defined areas of research. Antibody Qualification Associate participates in collaborative projects, and at times, assist other laboratory members on research-related activities.

 Reports to: Director, Technology Development

Essential Functions

  1. Perform experiments to determine titers of antibody raw materials for continued development in Design.
  2. Perform Histology, IHC, in situ Hybridization (ISH) and Immunofluorescence (IF) testing in the development of new products and the optimization of existing products.
  3. Assist in the closure of customer complaints and product investigation.
  4. Perform all activities in accordance with established SOP’s and directions from manager in a GMP and ISO regulated laboratory.
  5. Biocare’s Policy Management system Document all activities according to established procedures.
  6. Apply critical thinking and problem-solving skills to troubleshoot assays and identify areas for improvement.
  7. Monitor equipment and instrumentation for compliance to corporate procedures.
  8. At times performs histology and IHC for outside research-related projects (contractual projects) and participates in research projects for posters and publication.
  9. Other duties as assigned by Management.

Competencies

  1. Extensive experience in a laboratory environment, with an emphasis on high productivity and multi-tasking to progress on multiple projects simultaneously.
  2. Hands-on experience performing titrations of antibodies for IHC and probes for in situ hybridization Ability to work independently and manage tasks, while supporting fellow team members.
  3. Excellent verbal and written communication skills that produce clear, effective, and complete documentation.
  4. Highly organized with proofreading skills and good attention to details.
  5. Thorough understanding of product development in an ISO environment.
  6. Experience with policy and procedure management systems (i.e., Policy Tech).

Work Environment
This job operates in a research / laboratory environment. This role routinely uses standard laboratory equipment such as pipettes, automated instrumentation, microscopes, and ancillary equipment. In addition, this position routinely uses desktop or laptop computers. The worker is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work.)

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is required to crouch: Bending the body downward and forward by bending leg and spine. Reach: Extending hand(s) and arm(s) in any direction. Stand: Particularly for sustained periods of time. Walk: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. Finger: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling. Grasp: Applying pressure to an object with the fingers and palm. Feel: Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips. Talk: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Hear: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound. Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or fingers. Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. Specific vision abilities required for this job include close vision, distance vision, observation of color when looking under a microscope, color vision, peripheral vision, depth perception and ability to adjust and focus.

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Less than 10% travel is required. Required Education and Experience Bachelor’s Degree in Biology or a related field; or Associate Degree, with training in Histology & IHC. Two to five (2-5) years’ Laboratory experience in a related field, or equivalent combination of education and experience.

Required Education and Experience
Bachelor’s Degree in Biology or a related field; or Associate Degree, with training in Histology & IHC. Two to five (2-5) years’ Laboratory experience in a related field, or equivalent combination of education and experience.