Description
Compensation
The salary range for this role is $100K – $120K, with equity offered.
About the Role:
The Supervisor, CGMP Manufacturing – Downstream leads day-to-day downstream peptide production at our cGMP facility, including preparative HPLC purification, lyophilization, and final packaging.
Responsibilities:
Upstream Execution:
- Direct cGMP SPPS operations, including resin preparation, coupling and deprotection cycles, in-process checks, and resin washing and drying.
- Direct cleavage operations, including cocktail preparation, cleavage, filtration, precipitation, and isolation of crude peptide.
- Ensure upstream execution follows approved batch records, SOPs, and safety requirements.
Downstream Execution:
- Direct cGMP purification operations, including prep HPLC column packing and equilibration, loading, gradient runs, fraction collection, and pooling.
- Direct lyophilization and final isolation operations, including cycle execution, unloading, and final packaging and labeling.
- Ensure downstream execution follows approved batch records, SOPs, and safety requirements.
Equipment & Floor Operations:
- Oversee equipment readiness across upstream and downstream.
- Oversee equipment qualification, preventive maintenance, and vendor relationships.
- Troubleshoot issues on the floor in real time and escalate appropriately.
Scheduling:
- Build and manage the integrated upstream and downstream production schedule.
- Plan campaigns across multiple concurrent products.
- Coordinate the hand-off of crude peptide from upstream to downstream.
Process, Quality & Continuous Improvement:
- Lead investigations of deviations, failed batches, and process excursions.
- Author, review, and maintain master batch records, SOPs, and work instructions.
- Support scale-up, tech transfer, and new product introductions.
- Drive yield, throughput, and cost-efficiency improvements.
Audit Readiness & Compliance:
- Keep the area inspection-ready at all times.
- Ensure manufacturing operations comply with cGMP, internal SOPs, and master batch records.
- Support audits and regulatory inspections.
Team Development:
- Lead, coach, and develop chemists, operators, and technicians.
- Own onboarding and GMP training.
- Foster a culture of safety, initiative, accountability, and open communication.
Requirements:
- Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, or a related discipline.
- 3+ years of cGMP manufacturing experience in pharmaceutical, biopharmaceutical, or peptide manufacturing.
- Hands-on experience with preparative HPLC purification and lyophilization.
- 1+ years in a leadership or supervisory role managing production teams.
Preferred Qualifications:
- Experience with commercial-scale SPPS (upstream) or prep HPLC and lyophilization (downstream).
- Experience supporting process validation, PPQ campaigns, and tech transfer of new peptide products into GMP manufacturing.
Benefits:
- Competitive salary & equity compensation.
- 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.