Description
We are seeking a highly organized and execution-focused Project Manager to lead ramp-up and tech transfer activities for a peptide API manufacturing facility.
You will drive cross-functional coordination across Operations, Quality (QA/QC), and global partners to ensure successful process transfer, facility readiness, and on-time program delivery.
You Will:
- Lead end-to-end project management for peptide manufacturing technology transfers, process implementation, and startup activities.
- Develop, maintain, and execute detailed project plans, timelines, milestones, and risk mitigation strategies across multiple programs.
- Coordinate the transfer of peptide manufacturing processes, including SPPS, purification, and lyophilization, from R&D or external manufacturing sites into commercial operations.
- Partner with Manufacturing, Engineering, Quality, and Process Development teams to ensure successful process validation and GMP manufacturing readiness.
- Serve as the primary cross-functional project lead, coordinating activities across Operations, QA/QC, Engineering, Supply Chain, and global stakeholders.
- Facilitate project meetings, drive accountability, resolve cross-functional issues, and communicate project status to leadership.
- Partner with Quality to ensure all project activities comply with cGMP requirements and support the development of SOPs, batch records, validation protocols, and other controlled documentation.
- Support facility startup activities, including equipment qualification (IQ/OQ/PQ), operational readiness, and execution of initial GMP manufacturing campaigns.
- Help establish scalable project management processes, governance, and best practices to support a growing manufacturing organization.
- Collaborate with global teams and external partners to align technical requirements, project timelines, and key deliverables while effectively managing communication across multiple time zones.
You Have:
- Bachelor's degree in Chemical Engineering, Chemistry, Life Sciences, or a related scientific discipline.
- 5+ years of project management experience in pharmaceutical, biotechnology, or other regulated manufacturing environments.
- Direct experience leading technology transfer, process scale-up, manufacturing startup, or commercialization projects strongly preferred.
- Experience supporting peptide API manufacturing or other complex chemical manufacturing processes is a plus.
- Demonstrated success managing complex, cross-functional projects with aggressive timelines and multiple stakeholders.
- Strong understanding of technology transfer, process validation, and cGMP manufacturing workflows.
- Proven ability to influence cross-functional teams and drive alignment without direct authority.
- Highly organized with the ability to balance structure and execution in a fast-paced, evolving environment.
- Strong risk management and problem-solving skills, with the ability to anticipate challenges and implement practical solutions.
- Excellent written and verbal communication skills, with experience presenting to both technical and non-technical stakeholders.
- Comfortable collaborating with global teams and working flexible hours as needed to support international partners and project milestones.
Our Benefits:
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats