Senior Principal Investigator, Drug Product Process Development (Biologics)

Location: Wilmington, Delaware, United States; travel to CDMO sites approximately 15%.

Company

hirify.global is a biopharmaceutical company developing life-saving medicines and biologics product candidates.

What you will do

• Lead phase-appropriate drug product process development and manufacturing support for preclinical, clinical, registration, validation, and commercial activities.
• Design and oversee primary and registration batch manufacturing, process characterization, qualification, and validation.
• Manage CDMOs, CMOs, consultants, vendors, technical transfers, supply agreements, timelines, and budgets.
• Collaborate with Quality Assurance, Regulatory Affairs, Clinical Supply Chain, operations, and cross-functional product development teams.
• Author and review CMC sections for IND, IMPD, BLA, amendments, regulatory responses, Investigator’s Brochures, and Pharmacy Manuals.

Requirements

• PhD, MS, or BS in Biochemistry, Chemical Engineering, or a related field, with 15+ years of biopharmaceutical industry experience.
• Hands-on experience in cleanroom environments and biologics drug product manufacturing.
• Knowledge of drug substance thawing and compounding, sterile filtration, filling, stoppering, lyophilization, capping, visual inspection, and labeling.
• Experience with filtration systems, filling lines, filling isolators, environmental monitoring, CDMO management, risk management, deviations, root-cause investigations, and CAPAs.
• Experience writing CMC sections for IND and BLA submissions.
• Proactive, detail-oriented, collaborative, well-organized, and able to work effectively with minimal supervision in a fast-paced environment.

Nice to have

• Formulation development and lyophilization cycle development experience.
• Experience with drug product process characterization and validation, equipment validation, and cleaning validation.

Culture & Benefits

• Fast-paced environment with opportunities to contribute beyond the immediate scope of the role.
• Work with internal and external teams on biologics development and commercialization programs.
• Opportunity for professional growth and increased responsibility within the organization.