Cambrex
Scientist / Sr. Scientist, Analytical Development
Cambrex, Waltham, Massachusetts, United States, 02254
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 broad experience in method development of analytical technologies such as (U)HPLC, GC, KF, LC/MS, NMR, TGA, DSC, particle size analyzer, etc. 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.
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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 broad experience in method development of analytical technologies such as (U)HPLC, GC, KF, LC/MS, NMR, TGA, DSC, particle size analyzer, etc. 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.
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