Manager, Analytical R&D
$100,000–$130,000 year
On-siteChantilly, Virginia, United States
Job Summary
Manage day-to-day laboratory operations and supervise group activities, including planning method development, validation, and tech transfer for APIs, excipients, and finished products. Oversee analytical techniques, data interpretation, and troubleshooting while preparing and reviewing SOPs, protocols, and reports to ensure GMP compliance with FDA and ICH guidance. Coordinate in-process release testing, stability studies, and additional investigations such as cleaning validation and multimedia dissolution. Collaborate with product development, regulatory affairs, and quality teams to support new ANDA submissions and commercial launches, while investigating deviations and implementing CAPAs. Report regularly to the department and R&D heads, review staff performance, and maintain cGMP compliance across the AR&D function.
Required Qualifications
- Bachelor's degree in Analytical Chemistry or Chemistry or related field
- 10+ years of experience
- MS/PhD with 7+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical development
- Knowledge of API, excipient and finish product in generic pharmaceuticals
- Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size
- Functional understanding of small molecule analytical development and associated regulatory and quality requirements
- In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance
- Excellent verbal and written communication skills
- Excellent problem solving and interpersonal skills
- Must be able to stand for long periods of time (up to 12-hour shifts)
- Must be able to maneuver at least 40 pounds
- Must be able to wear a respirator and pass associated respirator tests and/or requirements
- Must be able to wear all required PPE
- Must be able to see details at close range (within a few feet of the observer)
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