Scientist, PRD (Process Analytical R&D)

Cambrex Corp.; Waltham (MA); On-site; USD 74,000 - 110,000; Full time

Benefits offered by this job

Healthcare

Life Insurance

Retirement planning

Job summary

Cambrex Corp. in Massachusetts is seeking a Senior Associate Scientist or Scientist for our Analytical R&D group.

The role focuses on providing high-quality analytical support for synthetic process development, with a strong foundation in organic chemistry and analytical sciences. The successful candidate will work on UHPLC, LC/MS, NMR, GC, and other techniques to characterize intermediates, APIs, and impurities, collaborating with process chemists to solve development challenges, while adhering

Qualifications

• BS or MS in chemistry with 3–5+ years in analytics; PhD with 0+ years welcome.
• Strong knowledge of analytical method development using UHPLC, LC/MS, NMR, and GC.
• Familiarity with GMP, regulatory requirements (FDA/EMA) and QC testing.
• Excellent written and verbal communication; cross-site collaboration.

Responsibilities

• Partner with Process Development to support route scouting and optimization.
• Develop analytical strategies to support scale-up and impurity investigations.
• Characterize intermediates, APIs, and impurities with multiple techniques.
• Lead method transfers and ensure GMP compliance.

Skills

Analytical chemistry

Organic chemistry

GMP compliance

Regulatory knowledge

Communication skills

Education

BS in Chemistry

MS in Chemistry

PhD in Chemistry

Tools

UHPLC/HPLC

GC

Karl Fischer

LC/MS

NMR

TGA

DSC

Particle size analysis

Job description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Job 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 with a strong foundation in organic chemistry and analytical sciences who is passionate about working in a fast-paced, dynamic environment.

The ideal candidate will hold a BS or MS in Chemistry with 3-5+ years of experience, or a PhD with 0+ years of experience in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related field within the pharmaceutical industry. The candidate should possess a strong understanding of synthetic chemistry and reaction processes, combined with broad experience in analytical method development using technologies such as (U)HPLC, GC, KF, LC/MS, NMR, TGA, DSC, particle size analysis, and other techniques used to characterize pharmaceutical intermediates, APIs, impurities, and process-related materials. Knowledge of regulatory guidelines and experience in quality control testing are preferred. Candidates must possess strong written and oral communication skills and be able to work closely with process chemists to solve complex development challenges.

Responsibilities

• Partner closely with Process Development scientists to support route scouting, reaction optimization, impurity investigations, and process understanding activities.
• Apply knowledge of organic chemistry, reaction mechanisms, and impurity formation pathways to develop analytical strategies that support process development and scale-up.
• Characterize reaction mixtures, intermediates, APIs, starting materials, and process impurities using a variety of analytical techniques.
• 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.

Qualifications/Skills

• Strong background in analytical chemistry with a solid understanding of organic chemistry, synthetic processes, and pharmaceutical process development.
• Experience supporting process chemistry programs through analytical method development, impurity characterization, reaction monitoring, and troubleshooting.
• Demonstrated understanding of synthetic reaction pathways, degradation mechanisms, impurity profiling, and control strategies.
• Proven experience in method development, validation, troubleshooting, and transfer for pharmaceutical intermediates, APIs, and 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.
• 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.

Education, Experience & Licensing Requirements

• 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.

The estimated salary range of $74,000 - $92,000 reflects an anticipated range for the Senior Associate Scientist, ARD position. The estimated salary range of $92,000 - $110,000 reflects an anticipated range for the Scientist, ARD position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, and certifications or other professional licenses held.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affi­mative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.