Job Title: Sr Scientist- Analytical Development ( No 3rd party submissions)

Reports To: Associate Director , Analytical Development

Location: Woburn, MA. On-Site ( Local Candidates only)

Job Type: Full-Time

About the Company

Asymchem Boston Corporation, is part of Asymchem Laboratories Co. Ltd., founded in 1999 as a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener, and more cost-effective manufacturing to support clinical research and commercialization. Asymchem currently operates eight manufacturing facilities offering solutions ranging from early clinical stage to commercial stage, including R&D, cGMP production of advanced intermediates, APIs, formulations, and clinical research services. Asymchem Group, headquartered in Tianjin, P. R. China. is a publicly traded company on the Shenzhen Stock Exchange (stock code 002821.SZ)

About the Role

This is an on-site role at 10 Gill Street, Suite J, Woburn, MA. The Senior Scientist of Analytical Development will lead analytical development activities for projects. This includes the development, qualification, and execution of analytical methods, and other related activities to provide product and process understanding for Active Pharmaceutical Ingredient (API) at the phase of early development to clinical trial.

Duties & Responsibilities:

• Lead analytical activities for development phase projects including planning and executing experiments, and summarizing data in reports, troubleshooting technical problems.
• Provide analytical development support for drug substance (and/or intermediates) using techniques including but not limited to HPLC, UPLC, GC, LC/MS, Karl Fisher, IR, NMR, dissolution and solid-state characterization.
• Phase appropriate development, qualification, and tech-transfer of analytical methods for starting materials, in-process control, DS testing to manufacture team.
• Support product release and stability study of API at development phases.
• Author and review test methods, analytical reports, protocols, SOPs to ensure consistent high quality.
• Serve as analytical development SME in internal cross functional team and external client meetings.
• Provide guidance to junior team members and deliver on-the-job training.
• Follow safety and chemical hygiene plan, responsible actions regarding chemical handling, storage and disposal.

Experience Requirements - Knowledge, Skills, & Abilities (KSAs):

• BS in Chemistry or a related field with 8+ years of relevant industrial experience in analytical development role
• MS in Chemistry or a related field with 5+ years of relevant industrial experience in analytical development role
• or Ph.D. in Chemistry or a related field with 3+ years of relevant industrial experience in analytical development role.
• Equivalent Experience will be considered in lieu of any degree.
• Prior experience on analytical method development for small molecule drug substance and/or drug product is desirable
• Technical expertise in analytical techniques including chromatography, and spectroscopy such as HPLC, GC, LC-MS, NMR, IR and KF.
• Familiar with Waters Empower Software and Electronic Laboratory Notebook (ELN) is a plus.
• Experience and knowledge of GMP compliance and ICH quality guidelines is highly desirable.
• Technical writing for regulatory dossiers (IND, IMPD, NDA, DMF etc.) is a plus.
• Ability to independently plan, organize and manage projects.
• Experience in managing scientific staff is a plus.
• Excellent oral and written communication skills for effective communication internally and externally.

Benefits:

• Day 1 Coverage for Medical, Vision (Co. Paid), and Dental Insurance
• Paid ~Life Insurance; Short-Term Disability (STD) & Long-Term Disability (LTD)
• Paid ~Holidays, Vacation & Sick Time
• Matching 401K