Bayer Sr Spec Protein Characterization in Berkeley, California
Your tasks and responsibilities
- Maintains subject matter expertise for Protein Characterization methods. Keeps current with revisions to test methods used in Protein Characterization division. Revises methods and related SOP’s affected by the changes and changes arising as a function of a CAPA, per approved Change Control.
- Leads technical training of staff employees
- Troubleshoot assays and analytical instrumentation, improves existing methods used in testing to optimize efficiency wherever possible. Establishes/maintains, minimizes workload, streamlining existing systems and ensuring adherence to all appropriate guidance both internally and externally. Contributes to continuous improvement opportunities by developing methods coordinating validation and drafting SOP’s where necessary.
- Investigates questionable test results, writes investigation/test plans, initiates and investigates IR’s and OOS/Invalid/Unexpected reports when applicable. Collaborates effectively with QA representatives to manage the initiation, investigation, and closure of incident reports.
- Maintains close interaction and communication with other QC divisions and QA groups to ensure on-time and dependable related decisions.
- Gathers information necessary to support changes to existing methods according to approved procedures. Initiates Change Control requests in Bayer’s document management system and follows through until the completion of workflows.
- Interacts with regulatory agencies, customers and internal auditors/inspectors. Represents QC Protein Characterization at operational and cross-functional meetings, prepares and presents information, provides decision making support at meetings and disseminates information back to QC Protein Characterization.
- Provides coaching for other junior analysts
Who you are
Minimum Education Bachelor's Degree in a science or technical field. Minimum Experience Minimum 6 years of experience in pharmaceutical or related industry or an equivalent combination of education and experience. 3+ years experience in the relevant (business need) technical and logistical specialty Special Skill/Knowledge • Demonstrable experience with cGMP and regulatory compliance (FDA, EMA and other international agencies). • Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments. • Thorough knowledge of chemical analytical methods, Chromatography (SEC, ION, NORMAL, REVERSE, ION-PAIR, etc), UPLC and wet chemistry . Knowledge of biologics and manufacturing processes. • Strong computer skills and knowledge (Word, Excel, Access, Powerpoint),. • Prior experience in a QC Protein Characterization laboratory and hands on experience with LIMS, SAP and related chromatographic software (EMPOWER). • Ability to work independently with minimum supervision • Ability to coach and train others
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.