- Guide CROs/CDMOs to design and perform method development and strategic validation of analytical controls employing required tests and quality measures for small molecule liquid, lyophilized, subcutaneous sterile, and solid oral dosage forms to critically assess formulation, process development, manufacture, and stability performance.
- Ensure analytical activities are aligned for the assigned projects' needs with the current regulatory, quality, and compliance requirements.
- Responsible for analytical activities such as developing/validating methods for NCEs from minimal information, methods transfer, developing specifications based on scientific data and release/stability testing, reference standards, and critical reagents meeting the highest quality deliverables.
- Author, review, and approve non-GMP documentation and ensure completeness of GMP test methods, qualification and validation protocols, stability protocols, and reports.
- Author and review SOPs relating to analytical development, quality control, and regulatory compliance.
- Collaborate transparently in a small, close team for an amicable consensus on analytical strategic plans and execute them independently in developing analytical technology controls to monitor process development, manufacture, QC, and QA for robust drug product evaluation and DS team to gain starter analytical knowledge transfer and alignment to deliver high-quality and regulatory DP/CMC documentation.
- Diligently review documentation as QC analyst with an appropriate level of compliance requirement and approve raw data to issue Certificates of Analysis for drug product batch release.
- Manage designated stability programs, review results to update/approve reports, file the approved documents in a GMP-compliant database, and track and trend the data to establish the shelf-life of drug products.
- Thoroughly investigates, reviews, and approves OOS/OOT, deviations, LIRs/CAPAs based on sound scientific root cause confirmation; follows up with required change controls; and reports and tracks abnormal results with scientific soundness and conclusion.
- Contribute technical expertise to designing phase-appropriate critical quality control strategies and stability studies for early to late-phase drug products.
- Provide vendors with efficient analytical know-how and leadership and manage their analytical activities and aligned timelines.
- Author and review Module 3 analytical sections in CTD format for IND, IMPD, NDA, MAA, and Briefing documents for regulatory-ready submissions and responses to questions.
- Support GMP/QMS-based evaluation, audit, and selection of analytical CROs/CDMOs.
- Contribute as an absolute team player with complete transparency, participate in team discussions, cross-training, and effectively communicate data and recommendations with the project cross-functional group(s) and senior management. · Responsible for analytical expenses within the allocated budgetary limits.
- Perform consistently with a high level of productivity and deliver the phase appropriate quality and accurate results quickly.
- Must include day-to-day hands-on experience with analytical methods such as HPLC / UPLC and GC, MS, dissolution, compendial, spectroscopy, KF, DSC, TGA, and working knowledge of microbiological methods such as MLT, endotoxins, sterility, etc., required to control and monitor sterile and oral drug products.
- Established track record in end-end phase-appropriate analytical method development and validation of methods for small molecule parenteral (liquid, lyophilized, and SC) and solid oral drug products.
- Demonstrated experience in cGMP and regulatory CMC, quality control, and compliance functions for analytical and microbiological/sterile methods development, and awareness of drug product development is strongly desired.
- Must demonstrate an in-depth understanding of GMPs, USP, EP, and ICH regulatory guidelines related to CMC activities.
- Knowledgeable in US FDA, EMEA, and HC regulatory analytical and QC testing requirements. Direct experience with CMC analytical requirements for IND/IMPD, NDA/MAA filing, and regulatory responding. Experience developing drug product specification requirements, control strategies, stability program management, and shelf-life establishment for early to late phase drug products.
- Testing, tracking, and trending of drug product critical quality attributes, including but not limited to release and stability data, impurity tracking and identification, impurity qualification as needed, and maintaining compliant databases and reporting.
- Strategic thinker, performs due diligence, has a high degree of accuracy, careful attention to details, and the ability to critically analyze, summarize, and present relevant data and significant conclusions to key stakeholders and decision-makers.
- Passionate about working in a close small team and matrix environment, independently performing informed judgment, strong organizational skills, and conveying written and verbal information effectively, efficiently, and timely.
- Demonstrated experience in CDMO management employing cross-functional collaboration skills. Ability to meet deadlines, make efficient and effective use of time, and manage multiple tasks with competing priorities.
- Follow procedures and perform assignments within established deadlines with high accuracy and close attention to detail.
- Work with the functional line to develop and manage budgetary requirements.
- Ability to travel up to 15% as/if required.
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Director, Drug Product Analytics - Wilmington, United States - Prelude Therapeutics
Description
ApplyDescription
As the Director of Drug Product Analytics, you will lead early to late-stage analytical development of sterile liquid, lyophilized parenteral, and solid oral dosage forms for small molecule oncology therapeutics.
Responsible for managing contract analytical activities and managing multiple contract service providers to deliver comprehensive, target quality, and compliant analytical results.
The successful candidate must demonstrate a proven track record of managing projects with minimal supervision in developing analytical methods and quality control strategy, data/review in detail, and systematic documentation, meeting all Phases of clinical study requirements.
Responsible for ensuring analytical development and stability activities meet regulatory CMC and quality compliance guidelines for IND/NDA/IMPD/MAA-ready submissions.Responsibilities
Ph.
D. in Organic/Analytical Chemistry or related discipline with 10+ years of pharmaceutical or biotech industry experience or M.S. in Organic/Analytical Chemistry, Pharmaceutical Analysis, or related field with 15+ years of progressively responsible experience as an analytics manager.
