Top 3 Must-Have Skill Sets

• 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

 
 
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.