Principal Scientist / Principal Engineer - Peptide Manufacturing

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 About the Company Snapdragon Chemistry, Inc. is a leader in chemical process development with expertise in continuous flow and process intensification technologies. Our company is catalyzing the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where organic chemistry underpins product development. We rely on our most valuable resource - our people - to maintain a leadership position in this market. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in flow chemistry and product development while also cultivating and furthering your career. At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture. Position Summary Cambrex Snapdragon Boston is currently seeking exceptional candidates for its Principal Scientist / Principal Engineer - Peptide Manufacturing position at its Waltham, MA R&D center. A successful candidate will be joining a group of innovative and entrepreneurial engineers and scientists to enable the delivery of high quality, complex chemical matter to our clients. We are seeking a highly experienced and innovative Principal Scientist or Principal Engineer with deep expertise in peptide synthesis and manufacturing to lead the development, scale-up, and commercialization of peptide-based drug substances. This role will be pivotal in bridging R&D and GMP manufacturing, optimizing synthetic strategies, and ensuring robust, compliant, and efficient peptide production processes. Responsibilities 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/Skills Required Experience and Skills: 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. Prefrred 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, Experience & Licensing Requirements Education: PhD. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, with 5-8+ years of peptide manufacturing experience; or M.S./B.S. 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.Education: PhD. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, with 5-8+ years of peptide manufacturing experience; or M.S./B.S. with 10+ years in peptide process development or GMP manufacturing.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.