Specialist Quality Control Chemistry

Company: Bayer
Location: Berkeley
Posted on: August 6, 2022

Job Description:

Specialist Quality Control Chemistry

In Bayer s Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Specialist Quality Control Chemistry, are to:

• Maintain 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;
• Lead 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;
• Investigate 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;
• Maintain close interaction and communication with other QC divisions and QA groups to ensure on-time and dependable related decisions;
• Gather 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;
• Interact 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;
• Provide coaching for other junior analysts.
  
  WHO YOU ARE
  
  your success will be driven by your demonstration of our life values. more specifically related to this position, Bayer seeks an incumbent who possesses the following:
  
  Required qualifications:
  
  
  • Bachelor's degree (preferred BS) in Biological Sciences, Biochemistry, Molecular Biology, Chemistry or related field.
  • Six (6)+ years of experience in pharmaceutical or related industry or an equivalent combination of education with at least 3+ years of experience in the relevant (business need) technical and logistical specialty;
  • 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.
    
    RELOCATION ASSISTANCE IS AVAILABLE
    YOUR APPLICATION
    Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
    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.
    IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its employees to be fully vaccinated against COVID-19. Bayer active employees are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer employees are also required to comply with state, local and customer requirements. Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 655001 Contact Us Email:
    
    Job Segment: QC, Testing, Pharmaceutical, Chemical Research, Compliance, Quality, Technology, Science, Engineering, Legal

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