Barrington James
Senior Scientist
Barrington James - New York, New York, us, 10261
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Recruitment Consultant at Barrington James | Recruiting Quality & Regulatory Professionals for Biotech’s - USA
We’re currently partnered with a global pharmaceutical organization looking to expand their R&D Scientific team. You’ll be the go-to expert for developing and validating analytical methods for drug products and manufacturing processes, working closely with both internal teams and external partners. Job Responsibilities: The Senior R&D Scientist will be responsible for developing and validating analytical methods for APIs, excipients, and drug products using techniques like HPLC, UPLC & LC-MS. Lead extractable & leachable (E&L) studies and evaluate materials from new vendors. You will oversee R&D stability studies and support pre-formulation, formulation, and process development. Draft high-quality technical documents (protocols, reports, and submission dossiers). Document key dossier sections for 505(b)(1), 505(b)(2), and 505(j) submissions. Lead studies to support FDA responses and address deficiency letters. The R&D Scientist will collaborate with CROs, CDMOs, and regulatory authorities (FDA/EU) on technical strategy and submissions. Troubleshoot and resolve quality events, providing actionable solutions and CAPAs. Mentor junior staff and support their development in analytical techniques. Job Requirements: You should have a PhD in Analytical Chemistry or related field Extensive experience with analytical techniques including HPLC, LC & UPLC Familiarity with USP, ICH, and FDA guidelines. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Science Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Barrington James by 2x Sign in to set job alerts for “Senior Scientist” roles.
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We’re currently partnered with a global pharmaceutical organization looking to expand their R&D Scientific team. You’ll be the go-to expert for developing and validating analytical methods for drug products and manufacturing processes, working closely with both internal teams and external partners. Job Responsibilities: The Senior R&D Scientist will be responsible for developing and validating analytical methods for APIs, excipients, and drug products using techniques like HPLC, UPLC & LC-MS. Lead extractable & leachable (E&L) studies and evaluate materials from new vendors. You will oversee R&D stability studies and support pre-formulation, formulation, and process development. Draft high-quality technical documents (protocols, reports, and submission dossiers). Document key dossier sections for 505(b)(1), 505(b)(2), and 505(j) submissions. Lead studies to support FDA responses and address deficiency letters. The R&D Scientist will collaborate with CROs, CDMOs, and regulatory authorities (FDA/EU) on technical strategy and submissions. Troubleshoot and resolve quality events, providing actionable solutions and CAPAs. Mentor junior staff and support their development in analytical techniques. Job Requirements: You should have a PhD in Analytical Chemistry or related field Extensive experience with analytical techniques including HPLC, LC & UPLC Familiarity with USP, ICH, and FDA guidelines. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Science Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Barrington James by 2x Sign in to set job alerts for “Senior Scientist” roles.
R&D Manager/Principal Scientist - Polymer Formulation
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New York, NY $115,000.00-$170,000.00 4 hours ago Elma, NY $85,000.00-$100,000.00 2 days ago Corning, NY $86,728.00-$119,251.00 3 weeks ago Clinical Scientist (Manager/Senior Manager), Oncology
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Ithaca, NY $62,000.00-$154,900.00 4 days ago Ithaca, NY $62,000.00-$154,900.00 2 weeks ago New York, United States $136,000.00-$212,800.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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