Scientist - Process Development, Upstream
About The Position
Catalent is seeking Scientists, Process Development – Upstream to support the development, optimization, characterization, and transfer of mammalian cell culture processes for biologics manufacturing. Scientists in this role may support projects across multiple development stages, including early-phase process development, process characterization, validation readiness, and clinical/commercial manufacturing support. Successful candidates may be assigned to different upstream development teams based on business needs and experience. Opportunities include support of early-stage process development programs as well as late-phase process characterization, validation, and commercial manufacturing initiatives. The successful candidate will combine strong laboratory expertise with data analysis, technical problem-solving, technical writing, and cross-functional collaboration to deliver high-quality process solutions for internal and client programs.
Requirements
- Bachelor's degree in a STEM discipline with a minimum of 6 years relevant experience, Master's degree with a minimum of 3 years relevant experience, or PhD with relevant academic experience.
- Experience with upstream process development, mammalian cell culture, bioreactor operations, or related biologics development activities.
- Ability to independently design, execute, analyze, and troubleshoot complex experiments in a fast-paced environment.
- Strong understanding of GMP documentation practices, data integrity requirements, and technical writing, including protocols, reports, and SOPs.
- Demonstrated analytical and problem-solving skills with the ability to interpret data, identify process improvements, and recommend technical solutions.
- Proficiency with Microsoft Office applications and laboratory or manufacturing software systems.
Nice To Haves
- Experience in upstream biologics process development, process characterization, or process optimization.
- Experience with technology transfer, validation support, scale-up, or commercial manufacturing programs.
- Working knowledge of statistical analysis tools and Design of Experiments (DOE).
- Experience with automated small-scale bioreactor systems such as Ambr® 250 or similar technologies.
- Experience authoring technical reports, protocols, and regulatory-supporting documentation.
- Experience in a GMP-regulated biopharmaceutical, biotechnology, or CDMO environment.
- Previous client-facing experience.
Responsibilities
- Design and execute upstream process development studies supporting biologics programs from early development through commercial readiness.
- Perform mammalian cell culture activities including cell bank thawing, seed train expansion, bioreactor operations, and analytical testing.
- Support process optimization, process characterization, scale-up, validation readiness, and technology transfer activities using platform methods and statistical tools, including Design of Experiments (DOE).
- Analyze experimental data and communicate results through presentations, technical recommendations, and project updates.
- Maintain GMP-compliant documentation and author or review technical documents including protocols, reports, SOPs, and regulatory-supporting documentation.
- Serve as a technical resource for internal teams and external clients by communicating project progress, presenting results, and supporting project execution.
- Contribute to continuous improvement initiatives, laboratory operations, and the training and mentoring of junior team members.
- Other responsibilities as needed.
Benefits
- Competitive compensation package, including incentive opportunity.
- Day-one medical, dental, and vision coverage.
- 401(k) with company match.
- Tuition reimbursement and professional development opportunities.
- Generous paid time off and holiday schedule (152 hours + 8 holidays)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
