Manage QC testing staff in performing quality control testing for drug product, drug substance, in process and raw materials in an efficient, cGMP compliant and safe manner. Major responsibilities include maintaining a high level of regulatory compliance and providing technical and compliance guidance on testing processes and results. Address technical/Analytical/Compliance issues related to QC testing and support Analytical development, Validation and transfers. Assume ownership of deviations, CAPA's, change controls and drive continuous improvement efforts including lab efficiencies , operational excellence endeavors. Support laboratory management during regulatory audits and serve as subject matter expert for QC assays.
Lead Exhibit proficiency in troubleshooting issues with sample discrepancies, instrumentation, equipment and methods. Provide testing/technical guidance on UV-VIS Spectrophotometry, HPLC, Total Protein, SDS-PAGE and others. 40%
Drive on-time closure of quality events gathering data from various sources across multiple groups. 10%
Participate in Writing, updating, reviewing, and peer proofing activities within and between departments as required. 10%
Lead a team of 3-5 Analysts ensuring individual training requirements are met and maintained. Train analysts on the theory and technical components, procedures, assays, and equipment within area of expertise. Enhance team communication and cohesiveness through coaching and developing direct reports. Serve as the Subject Matter Expert on assays under the purview of the role. 20%
Support audits and inspections including laboratory walk throughs, government agencies and Parent global quality teams. Drive remediation's through the area managers. Maintain laboratory in an audit prepare state. 10%
Support test method transfer between PSC departments, Sanofi Pasteur sites or external testing labs. 10%
BASIC QUALIFICATIONS / COMPETENCIES:
A Bachelor's degree with 4+ years experience in a regulated cGMP Laboratory setting OR
A Master's degree with 3+ years' experience in a regulated cGMP Laboratory setting
Proficiency in Chemistry based assays
Strong HPLC Experience
Experience managing others in cGMP laboratory management role
An understanding of routine QC operations, including testing and documentation practices
Method Validation/Transfer Experience
SKILLS / COMPETENCIES:
Proficiency in using Microsoft Office
Proven logic and decision-making abilities and critical thinking skills
Knowledge of continuous improvement techniques and problem-solving skills
Proven leadership, verbal and written communication, organizational, critical thinking, and action oriented
Field of Study: Chemistry/Biochemistry
Technical writing capability
Basic Statistical concepts and use in data analysis
Experience with laboratory electronic systems
Vaccine Testing experience is a big plus
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.
Principia Biopharma Inc.