Biological Safety Consultant – Cell-Line-Derived Medical Device (Freelance / consultant)

Biological Safety Consultant – Cell-Line-Derived Medical Device (Freelance / consultant)

Glyance | Remote, with occasional travel | Contract

We are an early-stage medtech company developing a collagen-based injectable. The material is produced by a human cell line grown in bioreactors, then purified. We plan to CE-mark it as a Class III device under EU MDR.

We are looking for an experienced expert to review the biological safety of our process before we lock the design. You will help us get it right early, and support us through our first conversations with a Notified Body.

What you will do

• Review our cell line, cell banking strategy and manufacturing process for biological safety risks
• Define the testing plan for master and working cell banks, including adventitious agents and genetic stability
• Assess tumorigenicity and oncogenicity risk for an immortalised, gene-edited human cell line
• Set and justify limits for residual DNA, host cell proteins and other process impurities
• Advise on viral clearance options that suit a collagen product
• Help write the biological safety sections of the technical file
• Join early scoping meetings with a Notified Body and the consulted authority

What we are looking for

• PhD in virology, molecular biology, cell biology or a related field
• 10+ years in biologics CMC or biosafety, ideally on cell-line-derived products
• Hands-on experience with ICH Q5A(R2), Q5D and Q6B
• You have designed cell bank testing programmes and viral clearance studies
• You understand the regulatory view of immortalised and gene-edited cell lines
• Good working knowledge of EU MDR, or a willingness to learn it fast

Nice to have

• Experience as a regulator or assessor (EMA, MHRA, PEI, ANSM or similar)
• Experience with collagen, ECM or other tissue-derived products
• Familiarity with ISO 10993 and ISO 14971
• Familiarity with CRISPR edit characterisation (off-target analysis, insertion site verification)

The engagement

• Freelance or part-time consulting
• Start with a scoped review of a few weeks, with the option of a longer role
• Remote

To apply, please see here: https://forms.cloud.microsoft/r/h8Rt6e7vqe and send your cv to the email listed.