Job Summary: The Director of Downstream Process Development will lead the development and optimization of downstream processes for the production of novel biologics. This role is responsible for designing, scaling up, and transferring purification processes from laboratory scale to manufacturing, ensuring compliance with regulatory guidelines and meeting project timelines. The ideal candidate will have extensive experience in chromatography, filtration, and process validation, as well as a strategic vision for developing innovative solutions in downstream processing.
Key Responsibilities:
Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement.
Establish clear objectives, KPIs, and development plans for team members.
Oversee the design, development, and optimization of downstream processes, including purification methods like chromatography (affinity, ion exchange, size exclusion, etc.), filtration, and ultrafiltration/diafiltration.
Lead efforts in process scaling and technology transfer from R&D to GMP manufacturing, ensuring robust and reproducible results.
Drive process characterization and validation in accordance with regulatory guidelines (FDA, EMA, ICH).
Perform CMC risk assessment activities in a phase-appropriate manner, ensuring proper measures are in place in support of production and filing requirements.
Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.).
Oversee the project lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones.
Identify opportunities for innovation and improvement in downstream processes, driving cost-effective and scalable solutions.
Travel 20-25% in support of manufacturing activities at CDMOs. Collaborate with cross-functional teams, including upstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success.
Qualifications & Requirements:
Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8-10 years of experience in downstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry.
Strong expertise in the purification of biologics, including monoclonal antibodies, proteins, viral vectors, or similar biologics.
Experience with scale-up and technology transfer to GMP manufacturing.
Extensive knowledge of downstream purification techniques (e.g., chromatography, filtration) and associated analytical methods.
Proven track record in process characterization, validation, and regulatory submissions.
Familiarity with automated process development tools and high-throughput screening technologies.
Experience working with CDMOs and external manufacturing partners.