Senior Manager – Analytical Development & Quality Control

Senior Manager – Analytical Development & Quality Control

Requirements

• BS or MS in Chemistry, Pharmaceutical Science or related discipline.
• 6+ years of relevant industrial experience in analytical development/QC.
• Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, QbD, process validation, manufacture sampling and testing, stability study, method validation and transfer, etc.
• Effective written and verbal communication skills and interpersonal skills.
• Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.
• Strong problem-solving skills with sound technically driven decision-making ability
• Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Ability to multi-task and thrive in a fast-paced innovative environment.

Responsibilities

• Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of RevMed clinical and commercial programs.
• Managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP).
• Participating in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.
• Providing support for stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.
• Coordinating and managing outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs), including but not limited to in-process control test, final release test, and stability study.
• Managing quality events related to QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.
• Authoring and/or reviewing QC related documents, including methods, protocols, reports and memos.
• Managing reference standards and reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.
• Collaborating with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.

Preferred Qualifications

• Experience in solid oral dosage including dissolution testing.
• Commercial QC experience is preferred.
• Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred.
• Chromatographic experience in development, optimization, and troubleshooting.