Senior Principal Investigator, Drug Product Process Development

Responsibilities

• Design and develop phase appropriate process/manufacturing to support preclinical and clinical studies.
• Design and oversee execution of drug product activities in preparation for registration and validation, and commercial activities.
• Manage and execute Primary/Registration batch manufacturing aligned with regulatory filings.
• Lead in RFP writing, technical transfer, process and method development, optimization, qualification, validation, and activities related to all manufacturing operations.
• Evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, negotiate effective supply/technical agreements.
• Work closely with contract manufacturers (CMOs), Supply Chain leads, Quality and operations partners to ensure supply continuity with optimal cost and quality.
• Participate in cross functional project teams for product development as CMC functional area representative.
• Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator’s Brochure and Pharmacy Manual.
• Ensures that key project milestones and schedules are met.
• Manage consultants, vendors, and CDMOs to meet agreed upon program timelines/budgets.
• Travel to various CDMO sites (15%)

Qualifications

• PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with 15+ years of experience in biopharmaceutical industry.
• Hands-on experience working in a cleanroom environment and in drug product manufacturing of biologics.
• Experience and knowledge in the entire drug product manufacturing process, from drug substance thawing and compounding, sterile filtration, filling, stoppering, lyophilization, capping, to visual inspection and labeling.
• Familiar with filtration systems, filling lines, filling isolators, and environmental monitoring.
• Experience in CDMO management and working closely with the Quality Assurance and Clinical Supply Chain Management functions.
• Experience in risk management, deviation and root-cause investigations and CAPAs.
• Experience in writing CMC sections of IND and BLA (Biologics License Application).
• Experience in formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation are highly desired.
• Proactive, detail-oriented, collaborative, and able to work effectively in a fast-paced environment with minimal supervision.
• Excellent Communication, Organization, And Collaborative Skills Are Essential.