Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The QC Senior Scientist will provide oversight in a fast paced, collaborative QC Analytical laboratory that supports GMP testing of clinical biological products. In addition to performing product testing, the Senior Scientist will provide oversight on project teams for both internal and client interactions and will author GMP documents such as SOPs, specifications, stability protocols, and method validation protocols and reports. The staff member will assist with the oversight of the daily laboratory operations and manage a small group of QC scientists. The successful candidate will have extensive laboratory compliance experience, exceptional attention to detail and have experience designing and implementing laboratory efficiency improvements.
- Conduct analytical testing and provide hands on training to staff
- Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved
- Provide subject matter expertise during internal project team meetings and interactions with clients
- Provide expertise for the IOPQ of laboratory instrumentation, analytical equipment troubleshooting and routine equipment maintenance
- Author stability summary reports, product specifications, stability protocols, SOPs, guidance documents and analytical methods
- Provide technical support during analytical method transfer into the QC laboratory
- Identify gaps, design collaborative solutions, and implement laboratory improvements
- Oversee laboratory investigations, deviations, OOS, and CAPAs.
- Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance biological manufacturing and release / stability testing
- Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP)
- Understanding of biologics manufacturing processes
- Excellent communication and collaboration skills
- Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).
- Proficient with Waters Empower, Sciex 32 Karat and Microsoft Office applications (Word, Excel)
- Experience with Waters HPLC, UPLC and Beckman PA800 CE systems
- Experience with ELISA based impurity or potency methods
- Method validation experience
- Attention to detail and highly organized
- BS in Biochemistry, Chemistry or related field with 8-12 years of experience and a minimum of 5 years of hands-on experience in a cGMP compliant laboratory.
The base pay range for this position at commencement of employment is expected to be $100,000 to $135,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.