About the Role:We are seeking a highly motivated, hands-on Operations Leader to help build and scale manufacturing operations for a peptide API facility. This role is responsible for establishing/enhancing production processes, implementing/modifying GMP systems, and leading day-to-day manufacturing activities. The ideal candidate thrives in fast-paced, ambiguous environments and is equally comfortable setting strategy and executing on the floor.
You Will:- Build and scale peptide API manufacturing operations from early-stage development through commercial readiness.
- Develop and implement production workflows for peptide synthesis, including SPPS, purification, and lyophilization.
- Drive facility readiness through equipment qualification (IQ/OQ/PQ), process validation, and manufacturing startup activities.
- Provide hands-on technical leadership by troubleshooting peptide synthesis, purification (HPLC), and downstream manufacturing processes.
- Lead and develop a growing manufacturing team while remaining actively engaged in day-to-day operations as needed.
- Establish production planning, scheduling, and operational systems to support scalable manufacturing.
- Build and implement cGMP-compliant quality systems, including batch records, SOPs, deviations, CAPAs, and change controls.
- Partner closely with Quality to establish a strong culture of compliance and prepare the facility for regulatory inspections (FDA, EMA, etc.).
- Collaborate with R&D to transfer peptide manufacturing processes into production and optimize processes for scalability, yield, and robustness.
- Identify and implement process improvements that increase operational efficiency, product quality, and manufacturing reliability.
- Establish and maintain environmental health and safety programs while proactively identifying and mitigating operational and compliance risks.
- Partner cross-functionally with Supply Chain, Engineering, Quality, and other stakeholders to ensure manufacturing readiness and continuous improvement.
- Support hiring, onboarding, training, and development of a high-performing manufacturing organization.
You Have:- Bachelor's degree or higher in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
- 8+ years of experience in pharmaceutical or biotechnology manufacturing, preferably including early-stage or startup environments.
- Direct experience in peptide API manufacturing strongly preferred.
- Proven experience building manufacturing processes, systems, and operational infrastructure from the ground up rather than inheriting mature operations.
- Hands-on technical expertise with solid-phase peptide synthesis (SPPS), peptide purification (HPLC), and downstream processing, with the ability to troubleshoot complex manufacturing challenges.
- Strong working knowledge of current Good Manufacturing Practices (cGMP), including experience implementing and maintaining quality systems in a regulated environment.
- Demonstrated ability to lead and develop small, growing technical teams while remaining actively involved in day-to-day operations.
- Ability to thrive in a fast-paced, evolving environment with limited resources, balancing competing priorities and adapting to changing business needs.
- A bias for action with strong decision-making skills, capable of driving progress with incomplete information while continuously improving processes and outcomes.
- Excellent problem-solving, communication, and cross-functional collaboration skills.
Our Benefits (there are more but here are some highlights):- 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
