Director, Drug Substance, Process Development & Manufacturing Sciences

Master’s degree or PhD in Engineering or a pertinent scientific discipline. Minimum 10+ years’ experience in CMC operations, with thorough working knowledge of cGMPs and regulatory requirements. Experienced CMC leader in the biotechnology industry. SME in a broad range of purification technologies and methods. Extensive and proven experience with process development, process characterization and process validation of drug substance (microbial and mammalian platforms). Proven track record of successful CMC project delivery in support of early-stage programs. Experience in early development including the transition of novel candidates from discovery through IND, Phase 1 and Phase 2 clinical trials. Proactively identify CMC risks and provide recommendations on mitigation. Identify, review and select external CROs, CDMOs and key consultants needed to allow smooth, efficient and cost-effective support for CMC programs. Excellent verbal and written communication skills. Self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards. Experience representing technical operations (CMC) at FDA meetings and regulatory inspections. Experience writing relevant CMC sections of regulatory documents/submissions. Strong technical acumen, leadership, organizational planning, and project management skills. Effectiveness in leading, managing and/or influencing people. Successful delivery on cost and schedule for projects.

Lead drug substance process development, scale-up and/or technical transfer projects from initiation through regulatory approval. Provide CMC oversight as it relates to project planning and execution, and on-going operations of assigned projects at CROs, CDMOs, etc. Significant cross functional collaboration with Quality, Quality Control, Analytical Development, Manufacturing, MS&T, Clinical and Regulatory functions. Provide CMC sections for regulatory filings (INDs, BLAs, etc.) and serve as a subject matter expert during regulatory agency meetings and/or inspections (FDA, EMA, etc.).