Cambrex
Scientist/Senior Scientist Analytical Development
Cambrex, Waltham, Massachusetts, United States, 02254
Overview
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 meaningful work, learn new skills in a safe environment, strengthen connections with coworkers and the community, and contribute to patient outcomes. We offer a competitive benefits package including healthcare, life insurance, retirement planning, and more. Job Overview
We are seeking exceptional candidates for the position of Scientist or Senior Scientist in Analytical Sciences. The successful candidate will join a team dedicated to providing high-quality analytical support for pharmaceutical process development projects in a fast-paced environment. This role requires a strong background in analytical chemistry in the pharmaceutical industry and the ability to lead method development, validation, transfer, and GMP/compliance activities. 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 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 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
Bachelor’s, Master’s, or PhD in chemistry or a 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 successful completion of a comprehensive pre-employment screen, which may include drug testing, criminal record checks, identity verification, reference checks, and education/employment verification as permitted by law. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or other protected characteristics.
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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 meaningful work, learn new skills in a safe environment, strengthen connections with coworkers and the community, and contribute to patient outcomes. We offer a competitive benefits package including healthcare, life insurance, retirement planning, and more. Job Overview
We are seeking exceptional candidates for the position of Scientist or Senior Scientist in Analytical Sciences. The successful candidate will join a team dedicated to providing high-quality analytical support for pharmaceutical process development projects in a fast-paced environment. This role requires a strong background in analytical chemistry in the pharmaceutical industry and the ability to lead method development, validation, transfer, and GMP/compliance activities. 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 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 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
Bachelor’s, Master’s, or PhD in chemistry or a 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 successful completion of a comprehensive pre-employment screen, which may include drug testing, criminal record checks, identity verification, reference checks, and education/employment verification as permitted by law. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or other protected characteristics.
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