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Sr, Manager, QC-API Manufacturing

$120k - $150k

Pharmaron Beijing Co. Ltd.

Position: Sr. Manager, QC-API Manufacturing Salary Range: $120,000-$150,000 Location: Coventry, RI (On-site) Job Overview: This position will support API manufacturing and QCA activities through managing QC Lab Testing Operations and GMP Compliance. Key Responsibilities Manage QC team to ensure the on-time and high quality GMP work to support the API manufacturing projects at the site. Assist in Method Transfer activities through managing method validation, method verification and raw material specification set up. Draft and review protocols, report, method and specifications. Communicate with Pharmaron colleagues as well as customers on project execution and project management. Establish and maintain metrics appropriate to GMP QC laboratories. Track and report analytical work to optimize the use of resources, and to optimize efficiency. Improve QC GMP compliance system. Review data, notebooks, logbooks and other GMP documents. Write, revise, develop and evaluate SOPs and other GMP documents. Manage the training program, develop training materials and ensure the training program meets SOP requirement. Actively participate in investigations, problem solving, and troubleshooting. Assist with investigation reports. Oversee 3rd party contract laboratories and maintain in a qualified state. Develop and motivate staff members for hard working, efficient execution, right-first time and good communication. Maintain good laboratory practices in compliance with safety and environmental requirements. Perform other related assignments and duties as required and assigned. What We’re Looking For Ph.D in Chemistry or related field with minimum of 5 year of postdoctoral or industry experience. BS or MS degree in chemistry or related field. 15+ Years of pharmaceutical industry experience. Working knowledge of cGMP and applicable FDA, EMA, and ICH guidelines. Ability to plan and manage QC activities and supervise staff. Expert application of core laboratory techniques and instrumentation to impact API, intermediates and starting materials. Good scientific judgment, Problem solving, Cross functional project management. Benefits Insurance including Medical, Dental & Vision with significant employer contributions. Employer-funded Health Reimbursement Account. Healthcare & Dependent Care Flexible Spending Accounts. 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance. 401k plan with generous employer match. Access to an Employee Assistance Program. As an Equal Employment Opportunity and Affir­mative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #J-18808-Ljbffr Pharmaron Beijing Co. Ltd.

Vacancy posted 2 days ago
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