We are building a sterile manufacturing operation from the ground up and are seeking an experienced lyophilization expert to lead the technical development of our freeze-drying processes and facility.
This is not a maintenance or operator position. We are looking for someone who has deep hands-on experience designing, developing, validating, and operating pharmaceutical lyophilization processes in a GMP environment.
The successful candidate will be instrumental in building every aspect of the operation—from facility design and cleanroom implementation to cycle development and commercial manufacturing.
Responsibilities
- Lead the design and implementation of a pharmaceutical lyophilization operation from an empty facility through commercial production.
- Develop and optimize lyophilization cycles for peptides, proteins, biologics, and small-molecule formulations.
- Design freeze-drying recipes based on formulation characteristics, thermal analysis, and process requirements.
- Select, install, commission, and qualify lyophilization equipment.
- Develop equipment specifications and work with vendors during installation and startup.
- Establish cleanroom procedures, environmental monitoring programs, and contamination control strategies.
- Assist in cleanroom layout, workflow design, personnel flow, and material flow.
- Develop SOPs, batch records, equipment procedures, and preventive maintenance programs.
- Support IQ/OQ/PQ, process validation, media fills, and ongoing process verification.
- Work closely with engineering, quality, and manufacturing to establish a robust GMP operation.
- Troubleshoot process failures, cycle optimization opportunities, and equipment issues.
- Assist with technology transfer and scale-up from development through commercial manufacturing.
Required Qualifications
- 10+ years of pharmaceutical lyophilization experience.
- Extensive experience with sterile injectable manufacturing.
- Demonstrated experience developing lyophilization cycles—not simply operating existing recipes.
- Strong understanding of:
- Primary and secondary drying
- Critical product temperature
- Collapse temperature (Tc)
- Glass transition temperature (Tg')
- Eutectic systems
- Shelf temperature optimization
- Chamber pressure optimization
- Controlled nucleation (preferred)
- Experience with peptides, proteins, biologics, and small-molecule formulations.
- Experience commissioning or bringing new lyophilization equipment online.
- Strong knowledge of aseptic processing and cGMP requirements.
- Experience establishing or operating ISO-classified cleanrooms.
- Familiarity with environmental monitoring, gowning programs, contamination control, and sterile operations.
- Experience writing SOPs, validation protocols, and GMP documentation.
- Ability to independently troubleshoot technical and operational issues.
Preferred Qualifications
- Experience building or significantly expanding a sterile manufacturing facility.
- Experience with Bosch, SP Scientific, Millrock, Telstar, GEA, or equivalent pharmaceutical lyophilizers.
- Experience with formulation development and excipient selection.
- Familiarity with FDA inspections and regulatory expectations.
- Experience supporting commercial manufacturing at scale.
- Engineering, pharmaceutical sciences, chemistry, or related technical degree (advanced degree preferred).
About the Opportunity
This is an opportunity to build something from the ground up. Rather than stepping into an established operation, you'll play a central role in creating the facility, selecting equipment, developing processes, and establishing the technical foundation for a growing sterile manufacturing business.
We're looking for someone who enjoys solving difficult technical problems, creating robust processes, and taking ownership of an operation that will continue to expand for years to come.
Pay: $65,000.00 - $80,000.00 per year
Benefits:
- Flexible schedule
- Health insurance
- Paid time off
Work Location: In person
