Senior Manager, Analytical Development & QC

The Opportunity:

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, the position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP), including managing stability programs, reference materials, and raw materials at contract organization. The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.

• Provide support for stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.

• Coordinate and manage 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.

• Manage 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.

• Author and/or review QC related documents, including methods, protocols, reports and memos.

• Lead method validation/transfer activities at CDMOs and / or contract testing labs (CTLs)

• Manage reference standards and reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.

• Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.

Required Skills, Experience and Education:

• 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.

Preferred Skills: 

• 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. #LI-Hybrid #LI-CT1