Senior Principal Investigator, Drug Product Technologies

Job Summary (Primary Function)

The Sr. Principal Investigator, Drug Product Technologies, reporting to DP Technologies (DPT) in Global Biopharmaceutical Development (GBD), is a critical role in our development team and will help lead the successful development and commercialization of biologics product candidates. The successful incumbent in this role will be a self-motivated, enthusiastic team player with a passion for playing a key role in the development of life-saving medicines.

Responsibilities

• Design and develop phase appropriate process/manufacturing to support preclinical and clinical studies.
• Lead in RFP writing, technical transfer, process and method development, optimization, qualification, validation, and activities related to all manufacturing operations, ensuring inclusive practices and diverse perspectives are considered.
• 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.
• Manage Interactive Response Technology (IRT) systems from specification, user acceptance testing and release to support randomization and management of CTM.
• Manage investigation, reporting and communication of outcomes from temperature excursions, product complaints, etc.
• 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.
• 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 CMOs sites (20%).

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Degree (such as PhD/MS/BS) in Biochemistry, Chemical Engineering, or related field with significant experience in the biopharmaceutical industry.
• Practical experience working in a controlled 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 collaborating effectively with the Quality Assurance and Clinical Supply Chain Management teams.
• Experience in risk management, deviation and root-cause investigations, and corrective and preventive actions (CAPAs).
• Proactive, detail-oriented, collaborative, and able to work effectively in a dynamic environment with minimal supervision.
• Excellent communication, organization, and collaborative skills are essential.
• Experience in formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation are highly valued.