Principal Project Manager (Biopharma)

Location: USA - NC - Durham - Hamlin Rd

Company

hirify.global provides biopharmaceutical manufacturing services, including new product introductions, product reintroductions, and technical transfer activities.

What you will do

• Own the NPI/PRI program for the Boulder site and coordinate inputs required for scheduled manufacturing starts.
• Monitor key milestones for resin selection and lock, bill of material development, process lock, and material procurement.
• Own technical transfer schedules and milestones, including Make-A-Batch, Test-A-Batch, process model completion, batch records, sample plans, LIMS coordination, and BOM maturity.
• Coordinate NPI/PRI change control, including implementation, deliverables, material changes, and process changes.
• Coordinate batch production records, supply chain readiness, and process overview training.
• Guide standardization of production record content and format while escalating risks that may affect manufacturing start dates.

Requirements

• Bachelor’s degree in engineering or bioscience, plus 8+ years of experience in the pharmaceutical or biotechnology field, or equivalent experience.
• 5+ years of management experience, including at least 5 years of project management and 5 years of GxP operations.
• Knowledge of cGMP decision-making in biopharmaceutical manufacturing, including quality systems, manufacturing, and validation.
• Strong technical writing, communication, presentation, coordination, problem-solving, and risk assessment skills.
• Proficiency with MS Project.
• Broad understanding of applicable codes and regulations, including Quality Systems and cGMP requirements across FDA, EU, and ICH jurisdictions.
• Ability to evaluate and escalate risk, deliver projects under aggressive timelines, develop staff, and provide coaching.
• Strong orientation toward quality and customer service, with a high level of integrity and personal responsibility.

Nice to have

• Background in process validation.
• PMP certification.
• LEAN or Six Sigma certification.

Culture & Benefits

• Full-time employment at the Durham, North Carolina site.
• hirify.global is an EEO/AA employer and encourages qualified applicants from diverse backgrounds to apply.