Sr. Manager, QC-API Manufacturing

Pharmaron • Coventry, RI

12d • Onsite

About The Position

This position will support API manufacturing and QCA activities through managing QC Lab Testing Operations and GMP Compliance. Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects , 1,000+ CMC programs , and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers . Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Requirements

• 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

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 meeting 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree