Biocompatibility Specialist I/II/Program Manager - In Vivo Services

Pacific BioLabs (PBL) is an independent Contract Research Laboratory offering cGMP/GLP testing services in animal sciences, biocompatibility, medical device safety, analytical chemistry, and microbiology. Founded in 1982, PBL is beginning a new chapter, applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech and medical device clients.

PBL has an immediate opening for Biocompatibility Specialist I/II/Program Manager in the In Vivo Services Department. Candidates must be able to demonstrate applicable knowledge of biocompatibility testing of medical devices and accompanying regulatory ISO 10993 (Biological Evaluation of Medical Devices) guidelines. The role works closely with the Director, In Vivo Services, shared project teams, and Business Development to provide deliverables in compliance with regulatory requirements. Applicants must have a fundamental understanding of in vivo and in vitro testing, processes for initial assessment/evaluation of medical devices, medical device manufacturing processes, biological evaluation plans, toxicological risk assessments, extractable/leachables testing, test sample preparation, risk management, and process management.

Responsibilities of the Biocompatibility Specialist I/II/Program Manager include:

• Primary Sponsor-facing representative of the PBL Biocompatibility Program.
• Perform initial biocompatibility assessment of Sponsor devices utilizing industry standards in complying with ISO 10993 in an evolving regulatory environment.
• Perform scientific reviews and/or analyzes data related to Sponsor devices to provide recommended guidelines and analyses for devices considering the regulatory implications of such reviews and analyses.
• Using both internal and external sources when working with Sponsors, develop biocompatibility strategies taking into consideration materials, design, and process.
• Manage the biological assessments of multiple projects at one time, providing critical review and interpretation of available data, and elevating project constraints to upper management as necessary.
• Facilitate laboratory testing activities, including test sample preparation, for cross-departmental projects.
• Assist Sponsors with regulatory questions and inquiries through the life cycle of biocompatibility testing at PBL.
• In collaboration with Management, Study Directors/Analysts, analyze, interpret, and draw conclusions from biocompatibility testing.
• Engage in development and improvement efforts of internal/external procedures and processes supporting the biocompatibility program.
• Internal technical document creation and approval.
• Representing PBL via participation in vendor shows, professional meetings, regulatory bodies, and Sponsor meetings.

• At least 3 years of experience in the field of medical device, pharmaceutical, toxicology, or biotechnology with expertise in biocompatibility assessment.
• Ability to understand and apply regulatory guidelines, including but not limited to FDA, GLP, cGMP, ISO 10993, ISO 17025, USP pharmacopeia, and EU MDD/MDR.
• Fundamental understanding of biomaterials, biocompatibility assessment and methodology, in vivo laboratory animal testing, in vitro cell-based assays, and chemical characterization.
• Experience in conveying scientific topics in a clear and comprehensive fashion.
• Team orientated, ability to work efficiently on common deliverables with cross-functional teams and to interact professionally at all organizational levels.
• Must be flexible with an 8 hour workday between the hours of 8 am to 6 pm Monday through Friday. Working outside standard business hours may be needed in support of Sponsor needs.
• Willingness to work with and/or around laboratory animals.
• Ability to participate in and/or manage multiple projects simultaneously.
• Strong problem-solving skills.
• Excellent organizational skills with attention to detail and accuracy.
• Excellent written and verbal communication skills.
• Must be able to work with persons of diverse background and function as a team.
• Must be able to follow verbal and written direction.

PBL Benefits Include:

• Medical insurance package including dental and vision
• Life insurance
• Flexible spending account
• 401(k) with company match
• Company observed holidays and paid time off

The pay range for this position is $120,000 to $180,000/year. The base pay offered will take into account internal equity and may vary depending on the candidate’s job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.

PBL is an equal opportunity employer committed to diversity and inclusion. PBL considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans’ status, or any other legally protected factors.