Aseptic fill finish manufacturing or manufacturing technical services experience including control strategies and process performance monitoring
Ability to use scientific principles with bench and pilot scale models for process performance characterization
Fill/finish process scale-up and technology transfer experience including gap analysis, root cause analysis, and risk assessment tools such as Fishbone diagrams and FMEA
Experience performing data analysis using advanced statistical/analytical techniques and statistical analysis software
Job Overview
Fully onsite role with standard working hours
BS with 1–2 years of experience required
Role focused on drug product process development for parenteral drug products
Candidate will perform experiments, organize data, analyze results, establish experimental design, develop and implement protocols, and communicate results to cross-functional teams with minimal supervision
Key Responsibilities
Design, execute, and document data packages related to drug product design and process development
Communicate findings through presentations
Develop solutions to technical problems during process characterization and aseptic manufacturing
Support clinical and commercial process introductions or process transfers into manufacturing network
Author and review technical protocols, reports, product impact assessments, and regulatory sections supporting IND and marketing submissions
Support fill/finish manufacturing operations through troubleshooting, root cause analysis, non-conformance investigations, and process improvements
Participate in cross-functional and matrix team environments
Preferred Qualifications
BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, or Biotechnology with 3+ years of pharmaceutical/biotechnology industry experience
MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, or Biotechnology
Experience with aseptic fill/finish unit operations including freeze/thaw, mixing, sterile filtration, filling, stoppering, and visual inspection
Understanding of process-related stresses impacting biologics quality and stability
Experience with process scale-up, technology transfer, process characterization, and active process monitoring
Familiarity with DOE and QbD principles
Familiarity with cGMPs, regulatory filings, and compliance for sterile injectable products manufactured by aseptic processing
Experience working with Analytical Sciences, Process Development, Manufacturing, Regulatory, Compliance, Quality, and Project Management teams
Strong organizational, technical problem-solving, and communication skills
Ability to learn dynamic information quickly
Familiarity with electronic record keeping, GMP, laboratory notebooks, statistical analysis, and laboratory or pilot plant process equipment
Nice to Have
Experience leveraging generative AI, LLMs, and in silico modeling to support research, development, and testing processes
Day-to-Day Responsibilities
Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection, and fill/finish process development
Apply science/engineering principles and first principles modeling to solve technical problems
Support commercialization and lifecycle management activities for pipeline and commercial products
Perform statistical and analytical data analysis
Author reports and present scientific data to team leads
Additional Information
Possible extension: Yes
Red flag: Preference for industry experience
Interview process: 2 interview rounds
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.
