Synthetic Chemistry Process Lead
2 weeks ago
Key Responsibilities:
- Maintain a comprehensive process knowledge database for Chemistry and Conjugation, encompassing related raw materials, scale, impurities, and data analysis using statistical or other methods.
- Collaborate with Contract Manufacturing Organizations (CMOs) to design and execute experiments testing process changes, analyzing results through statistical means or otherwise. Familiarity with One-Factor-At-A-Time (OFAT) and Design of Experiments (DoE) experimental design and analysis is beneficial.
- Provide technical support for Chemistry and/or Conjugation process-related investigations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, and other related activities.
- Work collaboratively with Analytical Development, Project Management, Manufacturing Operations, Quality Assurance (QA), Quality Control (QC), Regulatory, and Contract Manufacturers to achieve corporate objectives.
- Effectively communicate in both written and verbal forms with managers, peers, and external partners.
- Visit CMO sites as needed to inspect manufacturing readiness and process performance, perform Process Improvement Plan (PIP) and troubleshooting duties as necessary.
- Draft and review technical and regulatory documents supporting process and analytical development activities for regulatory filing and inspection purposes.
Qualifications and Experience:
- A PhD or MSc in Synthetic Organic Chemistry, Synthetic Method Development, or a related discipline; or a BSc in Chemistry with at least 5 years of specifically related industrial experience in Process and Analytical Development.
- Demonstrated expertise in multi-step synthetic campaigns to complex and/or difficult-to-purify molecular targets.
- Proven ability to rationally analyze and characterize chemical entities, including analytical method optimization and qualification.
- Proven track record in efficiently resolving technically challenging problems.
- Strong interpersonal and team skills, enabling collaboration in a fast-paced cross-functional environment.
- Experience working with third-party Contract Research Organizations (CROs) and CMOs to develop processes and analytical methods supporting Good Manufacturing Practice (GMP) manufacturing.
- Familiarity with process development, characterization, scale-up, and manufacturing in the cGMP environment is advantageous.
- Strong data management skills, including familiarity with statistical analysis of process information.
- Familiarity with protein expression and handling, and/or bioconjugation techniques is beneficial.
- Excellent oral and written communication skills, integrating complex data into clear and accurate reports and presentations.
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