Senior Associate Scientist / Scientist (Analytical R&D)

Cambrex

Waltham, Massachusetts

JOB DETAILS
SKILLS
Analysis Skills, Analytical Chemistry, Analytical Development, Application Programming Interface (API), Assays, Best Practices, Biotech and Pharmaceutical, Chemistry, Communication Skills, Current Good Manufacturing Practice (cGMP), Customer Relations, Entrepreneurship, FDA Requirements, GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Instrumentation, Laboratory, Liquid Chromatography-Mass Spectrometry (LC-MS), Maintain Compliance, Mentoring, Nuclear Magnetic Resonance, Organizational Skills, Outsourcing, Pharmaceutical Analysis, Physical Chemistry, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Product Support, Quality Control, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Research & Development (R&D), Standard Operating Procedures (SOP), Support Documentation, Team Player, Technical Leadership, Technical Presentation, Testing, Time Management, Writing Skills
LOCATION
Waltham, Massachusetts
POSTED
9 days ago
Overview:

Snapdragon Chemistry is seeking exceptional candidates for the position of Senior Associate Scientist or Scientist in our Analytical R&D group. The successful candidate will join a team of innovative and entrepreneurial scientists dedicated to providing high-quality analytical support for synthetic process development projects. We are looking for a candidate who has a passion for working in a fast-paced, dynamic environment.  The ideal candidate will hold at least a BS or MS in Chemistry with 3-5+ years of experience, or a PhD with 0+ years of experience in analytical chemistry within the pharmaceutical industry.  The candidate should have a broad experience of method development of analytical technologies such as (U)HPLC, GC, KF, LC/MS, NMR, TGA, DSC, particle size analyzer etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience in quality control testing are preferred.  Candidates must possess strong written and oral communication skills.

Responsibilities:
  • Develop, optimize, and qualify analytical methods for pharmaceutical intermediates, APIs, and high-value specialty chemicals.
  • Utilize analytical techniques, including (U)HPLC, GC, KF, LC/MS, NMR, TGA, DSC, particle size analysis, and wet chemistry assays.
  • Perform moisture content testing (e.g., Karl Fischer) and other physical/chemical property determinations.
  • Conduct USP and other compendial tests as required to support product release, stability, and compliance.
  • Author and review analytical protocols, reports, and SOPs in compliance with GMP and regulatory expectations.
  • Conduct GMP testing and documentation in support of batch release, stability studies, and method transfer activities.
  • Lead and execute method transfers between internal teams and external partners, ensuring technical alignment and smooth execution.
  • Engage in cross-site technical interactions, including collaborative work with Cambrex sites, to align analytical strategies and ensure project continuity.
  • Manage outsourced analytical testing at third-party laboratories, including project scoping, technical oversight, and data review.
  • Ensure all analytical work meets cGMP standards and company quality system requirements.
  • Maintain a strong sense of urgency to meet project timelines and client deliverables without compromising quality.
  • Communicate directly with clients to provide project updates, interpret results, address technical inquiries, and present analytical strategies and timelines.
  • Provide technical leadership, mentor junior scientists, and contribute to best practices in method development, validation, GMP compliance, and compendial testing.
Qualifications / Skills::
  • Proven experience in method development, validation, troubleshooting, and transfer for pharmaceutical synthetic molecules.
  • Broad expertise in analytical instrumentation, wet chemistry techniques, and data interpretation.
  • Experience performing moisture analysis (Karl Fischer) and other USP compendial tests.
  • Strong working knowledge of GMP requirements, ICH guidelines, and regulatory expectations (FDA, EMA).
  • Experience in quality control testing, stability programs, outsourced testing management, and cross-site collaboration preferred.
  • Peptide and/or oligonucleotide analytical experience is a plus but not required.
  • Demonstrated ability to work with urgency while maintaining accuracy and compliance.
  • Strong organizational, problem-solving, and communication skills (written and oral).
  • Ability to interact confidently with clients and work effectively in a fast-paced, multi-project environment.
Qualifications:
  • For the Senior Associate Scientist role, a BS or MS in chemistry or related field with 3-5+ years of experience is required. Pharmaceutical GMP experience is required. 
  • For the Scientist role, a BS, MS with 5-7+ years of experience or a PhD in chemistry or related field with 0+ years of experience is required. Pharmaceutical GMP experience is desired. 

About the Company

C

Cambrex

Cambrex is an innovative life sciences company with a refreshingly human approach. Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world.

With over 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets.

COMPANY SIZE
1,000 to 1,499 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1981
WEBSITE
http://www.cambrex.com