Principal Scientist, Analytical/Method Development
Proclinical is urgently recruiting for a Principal Scientist of Analytical/Method Development for a leading biotechnology company located in Boston, MA. As the Principal Scientist, you will contribute to the planning and execution of analytical development activities of small molecule candidates from the pre-Development Candidate stage through commercialization for both drug substances and drug products.
- Assist analytical functional lead to lead the design and execution of analytical method development, validation, and transfer for drug substances (DS) and drug products (DP) in development in collaboration with Quality Control.
- Develop and implement phase appropriate specifications in collaboration with key stakeholders.
- Apply critical thinking to the phase appropriate control strategies for DS and DP in collaboration with Process Chemistry, Formulation Development, and Quality.
- Manage analytical activities at Preferred Provider CMO partners.
- Work with Regulatory Affairs and Preferred Provider CMO's to author, manage and coordinate analytical-related sections for clinical regulatory submissions
- Author and/or review analytical development and validation reports
- Author and/or review pertinent sections of clinical and commercial regulatory submissions.
- Coordinate internal and external structural confirmation and elucidation studies for Reference Materials, impurities, unknowns, etc.
- Establish and maintain effective working relationships with key internal and external stakeholders.
- Ensure analytical milestone are completed to meet the program timelines
Skills and Requirements:
- S degree in chemistry or related discipline with 10+ years or PhD with 5+ years of experience in small molecule analytical development in the pharmaceutical industry.
- Experience with a broad array of chromatographic (HPLC, GC) toward stability indicating method development (assay/content uniformity/impurity method), spectroscopic techniques toward structural elucidation/characterization (mass spectrometry and NMR), dissolution method development and testing for drug product, Karl Fischer water content testing.
- Comprehensive understanding of analytical development, regulatory, and quality requirements, including GMPs and ICH guidelines.
- Experience in managing analytical outsourcing activities at CROs and CMOs
- Excellent communication skills, both written and verbal, keeping key stakeholders and management informed of status, issues and recommended solutions.
- Ability and track record of successfully working in cross-functional teams to progress projects as a representative of CMC team and/or CMC team leadership
- At home in a results-driven, highly accountable environment where you can make a clear impact
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.