Job Title: Manufacturing Transfer Specialist / Process Development Scientist (Scale-Up)
Job Description: Element Staffing is recruiting for a mid-level Manufacturing Transfer Specialist / Process Development Scientist for a fast-growing Contract Development and Manufacturing Organization (CDMO) specializing in sterile injectables and complex drug product scale-up located in San Diego, CA. This position sits directly at the operational bridge between R&D formulation concepts and commercial-scale cGMP manufacturing lines. The successful candidate will lead bench-to-pilot and production plant tech transfers, execute filter validation studies, optimize lyophilization cycles, and serve as a primary technical interface with external Contract Manufacturing Organizations (CMOs).
Duties/Responsibilities/Qualifications:
• Bench-to-Plant Scale-Up: Lead process development, scale-up, and technical transfer of liquid and lyophilized drug formulations from benchtop R&D to pilot and commercial-scale manufacturing plants.
• Master Batch Record (MBR) Oversight: Draft, review, and approve technical Master Batch Records (MBRs), executed batch records, campaign summaries, and process flow diagrams (PFDs) for pilot and full-scale production.
• Filter & Process Validation: Plan, execute, and document critical filter validation studies (bacterial retention, compatibility, extractables/leachables) and fluid-path equipment parameters for sterile processing lines.
• Lyophilization Cycle Optimization: Develop, scale, and optimize freeze-drying/lyophilization cycles for complex drug products, ensuring cycle robustness and product quality parameters during scale-up.
• CMO & Tech Transfer Interface: Act as the primary technical point-of-contact for external CMO/CDMO partners, managing facility fit evaluations, equipment gap analyses, and on-site manufacturing campaign oversight.
• Process Deviation & Root Cause Analysis: Lead investigations into scale-up anomalies, batch yield losses, and manufacturing plant deviations, implementing data-driven Corrective and Preventive Actions (CAPA).
Additional Information:
• Years of Experience: 3–5 years of hands-on process development, scale-up, or technology transfer experience in a cGMP pharmaceutical manufacturing plant or CDMO environment.
• Education: Bachelor’s (B.S.) or Master’s (M.S.) degree in Chemical Engineering, Bioengineering, Pharmaceutics, Chemistry, or a related discipline.
• Shift/Schedule: Standard daytime hours (Monday – Friday). Candidates must be flexible to support active manufacturing plant runs and periodic CMO travel.
• Requirements: Proven experience in bench-to-plant scale-up, MBR generation, filter validation, and lyophilization process parameters for sterile injectables or complex liquid formulations. Direct familiarity with cGMP scale-up guidelines, unit operations (mixing, sterile filtration, aseptic filling), and CMO interface management.
• Exclusions: Candidate backgrounds restricted primarily to bench analytical chemistry, routine QC release/stability testing, or pure method validation without direct manufacturing scale-up experience will not be considered.
• Compensation: $42.00 – $55.00/hr ($87,360 – $114,400 annualized equivalent) DOE
• Location: San Diego, CA
For immediate consideration, please send your resume to resumes.westcoast@element-staffing.com.
Keyword Cloud
Skill Areas:
Manufacturing Transfer Specialist, Process Development Scientist, Scale-Up Engineer, Technology Transfer, Tech Transfer Engineer, Bench-to-Pilot Scale, Commercial Manufacturing, Master Batch Records, MBR Review, Filter Validation, Lyophilization Scale-Up, Freeze Drying, Sterile Injectables, Aseptic Processing, Unit Operations, Facility Fit Analysis, Process Flow Diagrams, PFDs, CMO Interface, CDMO Management, Root Cause Analysis, CAPA, Process Optimization, cGMP Plant Operations.
Industry:
Biopharmaceutical Manufacturing, CDMO, CMO, Sterile Injectables, Complex Drug Product, Process Engineering, Technology Transfer, Life Sciences Staffing.
Geography:
San Diego, La Jolla, Sorrento Valley, Torrey Pines, Carlsbad, Oceanside, San Diego County, SoCal, Southern California, On-site.