Coventry, RI About Pharmaron 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 . To learn more, visit www.pharmaron.com .
Job Overview:
The Senior Scientist-Stability Manager, QC will support GMP manufacturing activities through analytical sample testing, data review and stability management in compliance with all applicable guidelines Key Responsibilities Manage stability studies, draft stability protocols and report, coordinate and perform sample testing. Train and mentor junior QC scientist, provide technical and compliance guidance. Review experimental data, notebooks, method, protocols / reports. Actively participate in investigation of laboratory deviations, OOS, OOT, and atypical results. Write investigation reports. Actively participate in project teams and perform assigned tasks. Ability to work successfully in both a team/matrix environment as well as independently. Ensure high quality in QC and analytical work, and accurately document all necessary and relevant information in a clear concise manner as per cGMPs. Participate, support and facilitate site audits as directed and required. Maintain good laboratory practices and in compliance with safety and environmental requirements. Write, revise, develop, and evaluate SOPs. Perform other related assignments and duties, as required and assigned. What We're Looking For MS with 6-8+ years of experience or BS with 8-10+ years of experience in pharmaceutical industry. Experienced in stability program management Expert in GMP QC compliance Experienced investigation of lab deviations, OOS, OOT and troubleshooting QC problems 3 years of experience with core analytical instrumentation such as
HPLC, GC, FTIR, KF
Evidence of ability to effectively contribute to multi-disciplinary scientific teams Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance Evidence of ability to effectively scientifically supervise staff Why Pharmaron? 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.
Collaborative Culture:
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits:
As part of our commitment to your well-being, we offer a comprehensive benefits package: 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 How to
Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! 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. #LI-KS1
