POSITION SUMMARY
The Technical Lead, Drug Substance & Drug Product Development serves as the scientific and operational anchor for CMC activities supporting the company’s live biotherapeutic product (LBP) pipeline. This individual provides strategic technical leadership across all stages of development - from early feasibility through late-stage clinical manufacturing - with accountability for drug substance (DS) process development, drug product (DP) formulation and fill/finish, and readiness for technology transfer. The role requires deep expertise in anaerobic and/or aerobic microbial bioprocessing, a rigorous CMC mindset, and the ability to translate complex scientific challenges into actionable development plans aligned with regulatory expectations.
KEY RESPONSIBILITIES
Drug Substance Development
- Direct in-house fermentation development activities, including bioreactor operation, media and feed optimization, process parameter screening, and scale-up from bench to pilot scale within internal laboratory facilities.
- Lead upstream and downstream process development for live biotherapeutic organisms, including strain characterization, fermentation optimization, harvest, and purification/concentration strategies appropriate for anaerobic and/or aerobic microbial systems.
- Define and optimize critical process parameters (CPPs) and critical quality attributes (CQAs) in support of design space development and process characterization studies conducted both in-house and at external sites.
- Coordinate technical activities with CDMO partners responsible for drug substance development and GMP manufacturing; serve as the technical point of contact for day-to-day scientific interactions, and perform batch reviews, deviation investigations and risk assessments.
- Author and review process development reports, batch records.
- Develop technology transfer packages and oversee execution of engineering and conformance runs at external manufacturing sites; ensure robust knowledge transfer from internal development to CDMO operations.
Drug Product Development
- Lead in-house formulation development activities, including excipient screening, cryoprotectant and lyoprotectant optimization, and assessment of formulation variables impacting organism viability, potency, and stability.
- Direct lyophilization process development internally and in collaboration with external lyophilization vendors and CDMOs, including cycle design, cycle optimization, and scale-up from laboratory lyophilizers to pilot and production-scale equipment.
- Oversee fill/finish process development, primary and in-process controls strategy; coordinate with contract fill/finish organizations on process fit assessments, and batch execution oversight.
- Collaborate with external vendors for specialized DP development activities and analytical development supporting formulation characterization and stability programs.
- Oversee drug substance and drug product stability programme including analysis of stability data.
CMC Strategy & Regulatory
- Serve as the DS/DP technical lead for cross-functional project teams; represent DS/DP development in program reviews, governance meetings, and due diligence activities.
- Develop and maintain integrated DS/DP development plans, risk registers, and stage-gate deliverables in alignment with target product profiles (TPPs), accounting for activities distributed across internal teams and the external partner network.
- Collaborate with Regulatory and CMC to prepare for and support regulatory agency interactions, including pre-IND, Type B, and scientific advice meetings, as well as INDs/IMPDs.
- Ensure development activities are conducted in compliance with applicable GxP, ICH, and FDA/EMA guidelines for biologics and microbiome-based therapies, whether executed internally or at external sites.
Team & External Partner Management
- Directly manage or mentor scientists and research associates within the DS/DP development group; provide technical guidance, set priorities, and support professional development.
- Contribute to supplier selection process for external development and manufacturing partners including CDMOs, contract analytical laboratories, lyophilization specialists, and packaging and cold-chain vendors.
- Maintain ongoing technical oversight of CDMO and vendor activities through regular cross-site communication, on-site visits, data review, and formal governance mechanisms; escalate and resolve technical issues in a timely manner.
- Collaborate closely with CMC, Analytical Development, Quality, Clinical Operations, and Supply Chain to ensure internal and external development activities are aligned and on schedule.
QUALIFICATIONS
Required
- Ph.D. in Microbiology, Biochemical Engineering, Pharmaceutical Sciences, or a closely related discipline.
- Minimum 5 years of directly applicable industry experience in pharmaceutical or biopharmaceutical drug substance and/or drug product development.
- Demonstrated experience with microbial bioprocesses; experience with anaerobic organisms, spore-forming bacteria, or complex microbial consortia strongly preferred.
- Hands-on expertise in downstream processing and/or drug product formulation, including lyophilization, vialing, and container-closure integrity.
- Thorough knowledge of ICH and GMP guidelines.
Preferred
- Prior experience at an LBP, microbiome therapeutics, or live biotherapeutic company.
- Experience managing CDMO relationships and overseeing technology transfer activities.
- Exposure to FDA or EMA interactions for biologics or novel pharmaceutical entities.
- Familiarity with relevant guidance documents for microbiome-based therapeutics (e.g., FDA Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products).
