Site Leader/ Operations Director - Peptide API
Listed on 2026-08-04
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Manufacturing / Production
Regulatory Compliance Specialist, Pharmaceutical Manufacturing, Lean Manufacturing / Six Sigma
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.
- 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.
- 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.
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
Hims considers all qualified applicants…
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