SRG is seeking a Scientist, Process Development for a client in Cambridge, MA.
This position is with a major biopharma company, and qualified candidates will have a PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or a related field and 1-2 years of related biopharma industry experience.
- Support process development, formulation, scale up, and process characterization of RNAi products.
- Work closely with cross-functional teams and contract manufacturing organizations on drug product development, process transfer and oversight of manufacturing processes.
- Lead formulation development and characterization of CNS DP. This includes literature review, experimental design, execution, data analysis, and report writing.
- Investigate the mechanism of particulate formation and identify the key DP components and the process parameters required for a robust phase II/III CNS DP formulation.
- Support the in-house and external CNS drug product production of non-clinical, developmental and clinical materials.
- Manage in-house lab activities for CNS DP Participate in cross functional project meetings, provide scientific expertise, and achieve DP deliverables.
- Technical support for optimization of contract manufacturing processes. Author and review of technical protocols and reports in support of manufacturing process characterization activities
- Author and review quality section of regulatory filings
- PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or a related field
- 1-2 years of experience in the biopharma industry supporting parenteral drug product formulation and drug delivery
- Strong understanding of formulation and process of designing experiments and interpreting results
- Hands-on experience in parenteral drug product formulation, aseptic operation, and process
- Expertise with analytical and characterization methods for drug products and processes including UPLC, HPLC, UV/vis spectroscopy, viscosity, density, titration and experience of compendia assays, particulate analysis, including micro flow imaging
- Proficient using JMP and MS office, including word, visio, excel, presentation, one note
- Excellent oral and written communication, and interpersonal skills
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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