POSITION SUMMARY
The Senior Scientist, Biological Process Development is a highly skilled and collaborative team member responsible for designing, executing, and interpreting experiments that advance drug substance process development for the company’s live biotherapeutic product (LBP) pipeline. This role spans both upstream and downstream processing activities for drug substance - from fermentation optimization and scale-up through harvest, concentration, lyophilization, and preparation for drug product manufacturing. In addition to strong bench science capabilities, the Senior Scientist will play an active role in coordinating technical activities with external contract development and manufacturing organizations (CDMOs) and specialist vendors, serving as an informed day-to-day liaison between internal development programs and the external partner network.
KEY RESPONSIBILITIES
Process Development
- Design and execute fermentation development experiments using bench-top and pilot-scale bioreactors, including operation of anaerobic culture systems appropriate for LBP organisms.
- Optimize culture media, seed train procedures, and process parameters to maximize product quality and ensure process robustness and consistency.
- Support scale-up activities from laboratory to pilot scale; generate data packages and technical summaries to support scale-up decisions and technology transfer to manufacturing partners.
- Develop and optimize downstream unit operations including centrifugation, filtration / concentration (e.g. tangential flow filtration), and lyophilization for LBP drug substance.
- Develop and characterize formulation intermediates and bulk drug substance presentations, including assessment of cryoprotectants, excipients, and storage conditions on organism stability.
- Plan and execute pilot stability studies for in-process intermediates and bulk drug substance; analyze and interpret data to establish in-process limits and bulk storage specifications.
CDMO & Vendor Coordination
- Serve as a technical contact for CDMO relationships related to DS/DP development, managing day-to-day scientific communication, protocol review and approval, batch record review, and data package assessment.
- Prepare comprehensive technology transfer packages including process descriptions, batch manufacturing records (BMRs), in-process control specifications, and raw material lists; support the execution of engineering and qualification runs at external sites.
- Collaborate with the external partners / CDMOs to ensure drug substance attributes and presentation are compatible with downstream lyophilization, fill/finish, and final formulation requirements.
- Coordinate upstream process development runs at CDMO facilities, including preparation of technical protocols, remote and on-site support during execution, and critical review of batch records and process data.
- Participate in technical review meetings with CDMO partners; clearly communicate process requirements, evaluate proposed process modifications, and escalate technical risks as appropriate.
Documentation, Mentorship & Collaboration
- Maintain accurate, timely, and audit-ready laboratory notebooks, experimental records, and electronic data files.
- Author and contribute to process development reports, technical summaries, standard operating procedures (SOPs).
- Ensure all in-house experimental work is conducted in compliance with applicable biosafety, EH&S, and laboratory safety requirements.
- Participate in internal scientific reviews, cross-functional team meetings, and project updates; present data clearly and concisely to diverse audiences including non-technical stakeholders.
- Provide day-to-day technical guidance and mentorship to scientists and research associates within the process development group.
- Collaborate closely with Analytical Development, CMC, Quality, Clinical, and Regulatory to ensure internal and external development activities are aligned and on schedule.
- Contribute to a culture of scientific rigor, continuous improvement, and open knowledge sharing across the company.
QUALIFICATIONS
Required
- Ph.D. in Microbiology, Biochemical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, or a closely related discipline with 3+ years of industry experience.
- Demonstrated hands-on expertise in microbial upstream process development, including bioreactor operation, media optimization, and process parameter characterization at bench and/or pilot scale.
- Practical experience in downstream processing of microbial products, including centrifugation, filtration, TFF, concentration, and bulk formulation.
- Strong scientific writing skills; experience authoring process development reports, SOPs.
Preferred
- Experience working with anaerobic organisms, spore-forming bacteria, or other fastidious microorganisms in a development or GMP-adjacent setting is strongly preferred.
- Prior experience at a live biotherapeutics, microbiome therapeutics, or cell-based medicine company.
- Familiarity with lyophilization as it relates to drug substance or drug product development for biological products.
- Exposure to GMP manufacturing environments, batch record review, or deviation investigation processes.
- Experience coordinating development or manufacturing activities with external CDMOs, CMOs, or contract laboratories, including preparation of technical documents and participation in cross-organizational technical reviews.
- Experience with GxP, ICH, and FDA/EMA guidelines for biologics and microbiome-based products.
