Senior Scientist
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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 levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionScience
• IndustriesPharmaceutical Manufacturing and Biotechnology Research

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