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Qc Senior Scientist, Analytical

Company

Evotec

Address , Redmond
Employment type FULL_TIME
Salary
Expires 2023-10-18
Posted at 8 months ago
Job Description
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.
Responsibilities:
  • Provide subject matter expertise during internal project team meetings and interactions with clients
  • Identify gaps, design collaborative solutions, and implement laboratory improvements
  • Conduct analytical testing and provide hands on training to staff
  • 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
  • Oversee laboratory investigations, deviations, OOS, and CAPAs.
  • Provide expertise for the IOPQ of laboratory instrumentation, analytical equipment troubleshooting and routine equipment maintenance
  • Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved
Requirements:
  • Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance biological manufacturing and release / stability testing
  • Excellent communication and collaboration skills
  • 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.
  • Attention to detail and highly organized
  • Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP)
  • 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
  • Method validation experience
  • Understanding of biologics manufacturing processes
  • Experience with ELISA based impurity or potency methods
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.