Scientist / Sr. Scientist, Analytical Development
- Cambrex
- Waltham, Massachusetts
- Full Time
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. Start a career where You Matter by applying today! Job Overview Snapdragon Chemistry is seeking exceptional candidates for the position of Scientist or Sr. Scientist in Analytical Sciences. 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 in Chemistry with 8+ years of experience, an MS with 5+ years of experience, or a PhD with 1+ 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. Education, Experience & Licensing Requirements A BS, MS or PhD in chemistry or related field. Pharmaceutical GMP experience is required. 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 / Affirmative 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.A BS, MS or PhD in chemistry or related field. Pharmaceutical GMP experience is required.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.