Senior Research Investigator II – Analytical Development, Biologics
Position Summary
This position will serve as a leader and SME in separation area of analytical development (LC/CE and related analytical techniques). The role will lead analytical development activities related to analysis of therapeutic proteins in multiple areas such as characterization, formulations development, and process development and manufacturing.
Roles and Responsibilities
• Major activities include product characterization, method development/optimization, methods transfer, and analytical support of process development and manufacturing.
• The role requires managing CRO/ CMOs in addition to in-house work.
• Serve as technical expert and SME in cross-functional team to review analytical data and provide guidance on method development and product characterization.
• Author/review method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and other relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
• Advance Amicus scientific and regulatory approaches via active participation and leadership across industry trade groups and conferences.
• Supervise, mentor and troubleshoot for junior scientists.
Requirements:
Requirements
• A PhD in chemistry, biochemistry or related field with 5+ years of relevant experience.
• Lead biologics analytical methods development/optimization activities and support process development, formulation development and manufacturing etc.
• Build the scientific knowledge, capabilities, and strategies in biomolecular characterization that enable fast to clinic/fast to market product development and commercialization.
• Define science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
Experience and Skills
• Deep knowledge and hands-on experience with analytical methods used for biopharmaceutical characterization, especially in the area of chromatography and CE (CE-SDS and cIEF).
• Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization.
• Experience in interacting with CROs/CMOs is preferred
• Experience working in a development, GMP and GLP environment as it applies to laboratory and stability functions
• Team oriented and able to manage multiple projects cross various development stages.
• Strong leadership, team building, organizational, communication and interpersonal skills.
• Excellent oral and writing skills.
Travel
• Position requires up to 25% USA and International travel
