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 Characterizationmethods. 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, improvesexisting methods used in testing to optimize efficiency whereverpossible. Establishes/maintains, minimizes workload, streamliningexisting systems and ensuring adherence to all appropriate guidance both internally and externally. Contributes to continuous improvementopportunities by developing methods coordinating validation and drafting SOP's where necessary;
- Investigate questionable test results, writes investigation/testplans, initiates, and investigates IR's and OOS/Invalid/Unexpectedreports when applicable. Collaborates effectively with QArepresentatives to manage the initiation, investigation, and closure ofincident reports;
- Maintain close interaction and communication with other QCdivisions and QA groups to ensure on-time and dependable relateddecisions;
- Gather information necessary to support changes to existingmethods according to approved procedures. Initiates Change Controlrequests in Bayer's document management system and follows through until the completion of workflows;
- Interact with regulatory agencies, customers and internalauditors/inspectors. Represents QC Protein Characterization atoperational and cross-functional meetings, prepares and presentsinformation, provides decision making support at meetings anddisseminates 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:
- 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