Sanofi Group QC Support Manager-Waltham, MA in Waltham, Massachusetts
We are seeking a highly-motivated QC Support Manager to join a dynamic Quality Assurance Technical Services Team. The QC Support Manager will support operational and technical aspects of clinical/commercial drug substance, drug product, reference standard, and GMP stability programs.
The successful candidate will have responsibilities is to ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and global regulatory guidelines. This includes support to the stability testing samples in CLO, supporting release testing, tracking and tackling the CLO for completion of testing, making sure the results are documented and validated in the LIMS Labware system. Additionally, the support is needed for drafting the investigation reports in enterprise system and presenting QC metric to the wide audiences. The QC support Manager routinely works with CMO/CLOs to ensure timelines are met for release and stability testing of product.
Track, maintain, measure the sample movements from different locations to ensure the timeliness of delivery to CLOs.
Ensures the necessary support is provided to QATS team by connecting with CLO to provide the timely results of the lots
Designs and manages studies. Collaborates with CLOs to ensure proper testing and reporting of stability and release samples
Track and monitor the samples from DS and DP sites to the CLOs
Proactively trends and evaluates the KPI of CLO and CMO for delivery of samples
Prepare and present the performance of lot release and stability testing cycle time
Participates in meetings and contributes toward the goals of the CMC team. Contributes to major/critical manufacturing investigations with potential product impact, and leads stability investigations (deviations, OOS, cross-site and cross-functional).
A Master of Science or Ph D ( Biotech, Bioprocess ) within the following fields of study: Analytical Chemistry, Biochemistry, Biology, Chemistry, Organic Chemistry, Pharmaceutical Chemistry, Protein Chemistry) or a in a similar field of study.
A minimum of 6 years of relevant industry experience, with at least a minimum 3 years of direct experience in QC laboratory in biological industry.
8 years industry experience in QA and QC preferred with computational savvy skills
Knowledge of analytical methods especially bioassay, biochemistry and biophysical assay is preferred with strong ability to analyze data.
Expertise on how to support QC functions is essential in QC operations team
Experience on sample management with CLOs and analytical method validation
Good understanding of statistical analysis and interpretation of data. Proficiency with cGMPs and experience with Microsoft Office (Word, Excel, PowerPoint) and SAS JMP are required.
Strong technical writing skills and communication skills are essential
Bioverativ is a global biotechnology company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 as an independent company spun out of Biogen’s hemophilia business, we build upon a strong heritage of scientific innovation and are committed to actively working with the rare blood disorders community. The company’s mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in more than two decades. For more information, visit www.bioverativ.com or follow @bioverativ on Twitter.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.
VEVRAA Federal Contractor
We Request Priority Protected Veteran and Disabled Referrals for all our locations.
Bioverativ is an E-Verify Employer in the United States
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life