Director/Senior Director, Biologics Drug Substance Development

Key Responsibilities: Process Development & Technical Leadership: Lead cell line, cell culture, and purification process development for biologics drug substance. Provide technical leadership and strategic direction for drug substance development across programs. Process Characterization & Validation Lead late-stage process characterization to establish process understanding, identify critical process parameters (CPPs), and develop robust process control strategies. Lead process validation/PPQ, including validation strategy, protocol development, execution, data analysis, and troubleshooting. Technology Transfer & Manufacturing Lead scale-up, technology transfer, and manufacturing readiness activities from development through commercial manufacturing. Manage external development and manufacturing partners/CDMOs and ensure successful execution of technical activities and program milestones. Identify technical risks and develop effective mitigation strategies to support program timelines and successful regulatory and manufacturing outcomes. Regulatory Support Support preparation and submission of BLA/MAA CMC documentation, with a focus on drug substance process development, characterization, validation, and manufacturing. Provide technical leadership during regulatory interactions and preparation of responses to agency questions. Team & Partner Management Manage staff across cell line, upstream, and downstream process development. Work closely with Quality, Regulatory, Manufacturing, and external partners/CDMOs.

What You Bring: Ph. D. or M.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related scientific discipline. 10+ years of industry experience in biologics process development and CMC, with increasing levels of technical and leadership responsibility. Strong experience in cell line, upstream, and/or downstream process development, with a broad understanding of biologics drug substance manufacturing. Demonstrated experience leading late-stage process characterization and process validation/PPQ. Direct experience supporting or leading a BLA submission and associated regulatory interactions. Experience with technology transfer, commercial-scale manufacturing, and manufacturing process implementation. Experience working effectively with CDMOs and external development/manufacturing partners. Strong understanding of biologics CMC, QbD, risk assessment, CPP/CQA relationships, and process control strategies. Proven ability to lead technical teams and cross-functional development programs. Excellent scientific judgment, problem-solving, communication, and collaboration skills. The position will be based in the United States. We are committed to ensuring all employees, both current and future, receive fair and equitable pay. Base pay is one component of the total compensation package, and is determined within a range according to role, level, and location. This provides the opportunity for growth as you gain experience and develop within a role, while also allowing for differentiation based on performance. The base pay range for this role is between $185,000-$290,000 and reflects our good faith estimate of the minimum and maximum target for the position as of the date of posting and may be modified in the future. The final base pay within the range will be determined by work location and additional factors, including job-related skills, experience, relevant education or training, and market demand for your expertise. Ollin RECRUITING:Ollin Biosciences, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, pregnancy, genetic information, veteran status, disability, or any other protected characteristic as outlined by federal, state or local laws. We are committed to creating an inclusive environment for all employees. Ollin Biosciences, Inc. does not accept unsolicited resumes from any agency that we have not directly engaged for a specific role. Our managers and employees will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to Ollin Biosciences, Inc. from recruiters do not constitute any type of relationship between the recruiter and/or recruiting agency and Ollin Biosciences, Inc. and do not obligate Ollin Biosciences, Inc. to pay fees should we hire from those resumes.