Scientist/Sr Scientist- Analytical Development

Asymchem Group; Woburn (MA); On-site; USD 100,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Scientist for Analytical Development to lead critical projects in drug R&D. This role involves developing and qualifying analytical methods, ensuring high-quality standards, and providing expert guidance to junior staff. Join a forward-thinking company dedicated to innovative and sustainable pharmaceutical solutions, where your contributions will directly impact clinical research and commercialization efforts. If you are passionate about advancing drug development and thrive in a collaborative environment, this opportunity is perfect for you.

Benefits

Medical Insurance

Vision Insurance

Dental Insurance

Life Insurance

Short-Term Disability

Long-Term Disability

Paid Holidays

Paid Vacation

401K Matching

Qualifications

• 8+ years of experience in analytical development for drug substances.
• Technical expertise in chromatography and spectroscopy techniques.
• Experience with GMP compliance and ICH quality guidelines.

Responsibilities

• Lead analytical activities for development phase projects.
• Provide analytical development support for drug substances.
• Author and review test methods and analytical reports.

Skills

Analytical Method Development

HPLC

GC

LC-MS

NMR

IR

Technical Writing

Project Management

Communication Skills

Education

BS in Chemistry or related field

MS in Chemistry or related field

Ph.D. in Chemistry or related field

Tools

Waters Empower Software

Electronic Laboratory Notebook (ELN)

Job description

Scientist/Sr Scientist- Analytical Development

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Scientist/Sr Scientist- Analytical Development

Join to apply for the Scientist/Sr Scientist- Analytical Development role at Asymchem Group

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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.
• 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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