Principal Scientist, Analytical Development Position Available In Miami-Dade, Florida

Location:

REMOTE Salary:

$110,000.00 USD Annually – $145,000.00

USD Annually Description:

Our client is currently seeking a Principal Scientist, Analytical Development The Principal Scientist, Analytical Development (CMC) role is pivotal in ensuring the development, validation, and regulatory readiness of drug substance (DS) and drug product (DP) analytical methods, as well as overseeing the document organization, batch release, and regulatory submissions. The ideal candidate is highly skilled and detail-oriented with a strong background in analytical development, regulatory compliance, and technical report writing.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to: Design, review, and approve DS and DP method transfer, method validation, method development, and test method documentation. Author and review IND/NDA sections related to DS & DP analytical methods. Evaluate and analyze SPE method data for placebo fingerprinting and method bridging. Serve as the Module 3 authoring resource, including creating tables and performing data quality assessments (DQA). Author and review development reports, technical reports, and related documentation for regulatory submissions. Review stability data and author corresponding IND/NDA sections. Track retest dates for impurities, reference standards, and APIs to ensure compliance. Oversee DP batch release activities, including reviewing Company documentation to confirm adherence to GMPs and checklist completion. Conduct protocol and technical report reviews to ensure accuracy and compliance. Maintain and organize analytical documents on SharePoint, ensuring the latest versions are accessible. Review and approve documentation related to stability, testing methods, and regulatory submissions. Partner cross-functionally with internal and external stakeholders to advance analytical method development. Implement best practices for documentation and analytical development processes.

Qualifications:

PhD in Chemistry, Analytical Chemistry, or related field, with 8+ years of relevant experience in the pharmaceutical/biotech industry (or equivalent combination of education and experience). Expertise in analytical method development, validation, and regulatory requirements (IND/NDA submissions). Strong knowledge of GMPs, ICH guidelines, and stability study protocols. Proficiency in SharePoint for document management. Excellent organizational, communication, and technical writing skills. Proven ability to manage multiple priorities and meet deadlines in a fast-paced environment. Experience with SPE methods and placebo fingerprinting analysis. Previous experience in CMC roles or supporting regulatory submissions. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively “Judge”) to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge’s Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.

Contact:

arawat@judge.com This job and many more are available through The Judge Group. Find us on the web at www.judge.com