Cambrex
Principal Scientist / Principal Engineer - Peptide Manufacturing
Cambrex, Waltham, Massachusetts, United States, 02254
Overview
Cambrex Snapdragon Boston is currently seeking exceptional candidates for its Principal Scientist / Principal Engineer - Peptide Manufacturing role at its Waltham, MA R&D center. The successful candidate will join a group of innovative and entrepreneurial engineers and scientists to enable the delivery of high quality, complex chemical matter to our clients. This role focuses on peptide synthesis and manufacturing to bridge R&D and GMP manufacturing, optimize synthetic strategies, and ensure robust, compliant, and efficient peptide production processes. Responsibilities
Lead process development and scale-up of peptide synthesis, including solid-phase peptide synthesis (SPPS), solution-phase synthesis, cleavage, purification, and lyophilization. Design and execute DOE studies to optimize reaction conditions, resin loading, coupling strategies, and purification and isolation methods (e.g., RP-HPLC, IEC, TFF, lyophilization). Evaluate and select appropriate resins, reagents, and solvents for phase-appropriate manufacturing. Partner with analytical development to define and control critical quality attributes (CQAs) and critical process parameters (CPPs). Lead tech transfer of peptide processes to internal or external GMP manufacturing sites; serve as technical SME during manufacturing campaigns. Author and review process development reports, batch records, validation protocols, CMC documentation (e.g., Module 3), and regulatory filings (IND, NDA). Collaborate cross-functionally with QA, QC, regulatory, and supply chain to ensure technical alignment and compliance. Troubleshoot scale-up issues, support deviation investigations, and lead process improvements based on data-driven risk assessments. Mentor junior scientists and engineers; contribute to building peptide capabilities and infrastructure. Qualifications
Expertise in SPPS instrumentation (e.g., CEM, Biotage, CS Bio, Liberty Blue) and downstream peptide purification. Proven experience with GMP manufacturing and tech transfer of peptide APIs. Strong understanding of regulatory guidelines (ICH Q8/Q9/Q11, FDA/EMA expectations) and process validation. Familiarity with quality risk management, ICH M4/CTD, and QbD principles. Excellent problem-solving, communication, and project leadership skills. Understanding of quality control testing, specifications, and GMP documentation requirements. Proficiency in analytical method development and interpretation, with working knowledge of HPLC, LC-MS, and other relevant techniques for peptide characterization. Prior experience in a CDMO or biopharma setting strongly preferred. Preferred Skills
Experience with cyclic peptides, conjugates (e.g., PEGylated, lipidated peptides), or complex synthetic intermediates. Working knowledge of Peptide-Drug Conjugates (PDCs) or hybrid synthesis technologies. Familiarity with automation platforms and digital process monitoring tools. Why Join Us
Innovative science and cutting-edge facilities Collaborative and growth-oriented culture Opportunity to make a global impact in therapeutic development Education
PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, with 5-8+ years of peptide manufacturing experience; or MS/BS with 10+ years in peptide process development or GMP manufacturing. 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. Seniority level
Mid-Senior level Employment type
Full-time Industries
Pharmaceutical Manufacturing
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Cambrex Snapdragon Boston is currently seeking exceptional candidates for its Principal Scientist / Principal Engineer - Peptide Manufacturing role at its Waltham, MA R&D center. The successful candidate will join a group of innovative and entrepreneurial engineers and scientists to enable the delivery of high quality, complex chemical matter to our clients. This role focuses on peptide synthesis and manufacturing to bridge R&D and GMP manufacturing, optimize synthetic strategies, and ensure robust, compliant, and efficient peptide production processes. Responsibilities
Lead process development and scale-up of peptide synthesis, including solid-phase peptide synthesis (SPPS), solution-phase synthesis, cleavage, purification, and lyophilization. Design and execute DOE studies to optimize reaction conditions, resin loading, coupling strategies, and purification and isolation methods (e.g., RP-HPLC, IEC, TFF, lyophilization). Evaluate and select appropriate resins, reagents, and solvents for phase-appropriate manufacturing. Partner with analytical development to define and control critical quality attributes (CQAs) and critical process parameters (CPPs). Lead tech transfer of peptide processes to internal or external GMP manufacturing sites; serve as technical SME during manufacturing campaigns. Author and review process development reports, batch records, validation protocols, CMC documentation (e.g., Module 3), and regulatory filings (IND, NDA). Collaborate cross-functionally with QA, QC, regulatory, and supply chain to ensure technical alignment and compliance. Troubleshoot scale-up issues, support deviation investigations, and lead process improvements based on data-driven risk assessments. Mentor junior scientists and engineers; contribute to building peptide capabilities and infrastructure. Qualifications
Expertise in SPPS instrumentation (e.g., CEM, Biotage, CS Bio, Liberty Blue) and downstream peptide purification. Proven experience with GMP manufacturing and tech transfer of peptide APIs. Strong understanding of regulatory guidelines (ICH Q8/Q9/Q11, FDA/EMA expectations) and process validation. Familiarity with quality risk management, ICH M4/CTD, and QbD principles. Excellent problem-solving, communication, and project leadership skills. Understanding of quality control testing, specifications, and GMP documentation requirements. Proficiency in analytical method development and interpretation, with working knowledge of HPLC, LC-MS, and other relevant techniques for peptide characterization. Prior experience in a CDMO or biopharma setting strongly preferred. Preferred Skills
Experience with cyclic peptides, conjugates (e.g., PEGylated, lipidated peptides), or complex synthetic intermediates. Working knowledge of Peptide-Drug Conjugates (PDCs) or hybrid synthesis technologies. Familiarity with automation platforms and digital process monitoring tools. Why Join Us
Innovative science and cutting-edge facilities Collaborative and growth-oriented culture Opportunity to make a global impact in therapeutic development Education
PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, with 5-8+ years of peptide manufacturing experience; or MS/BS with 10+ years in peptide process development or GMP manufacturing. 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. Seniority level
Mid-Senior level Employment type
Full-time Industries
Pharmaceutical Manufacturing
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