Your tasks and responsibilities
The primary responsibilities of this role, Director Quality Control Analytical Chemistry, are to:
Who you are
- Provide scientific and operational leadership in the areas of cGMP-compliant biopharmaceutical testing services that include protein characterization, product and intermediate characterization, release testing, facility/utility testing, method validation, and potency testing.
- Provide effective leadership including: developing and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; assisting with Performance Calibration/Talent Pool Management; individual goal setting/performance reviews; managing the development of employees, training and development; quality and safety and supporting supervisors/managers in individual/department/business objectives.
- Provide technical expertise in the performance in the areas of responsibility and share with / transfer to the functional areas within the Bayer Biotech network.
- Possess a strong and current knowledge of cGMP compliance and maintain strong cGMP Compliance in the activities of the Chemistry function. Interfaces with regulators, inspectors and can interpret cGMP to solve technical issues using scientific compliant solutions. Familiarization with Quality Systems (OOS, CAPA, Deviations, etc.) and Data Integrity requirements.
- Work collaboratively with Bayer Supply Center functions and the Bayer Biotech network, to ensure that QC analytical methods are aligned with process needs/capabilities and product requirements. Identify and address technical and validation gaps in analytical methods and implement improvements in analytical methods per ICH requirements.
- Develop and implement operational excellence initiatives to increase productivity and quality, and decrease cost and cycle time
- Identify and address potential problems related to the successful delivery of Chemistry and Infrastructure services.
- Address unanticipated issues and problems in an expedient, efficient and cost effective manner
- Provide support to the functions of the Quality organization outside of areas of direct managerial and technical responsibility, with specific focus on the Bayer Biotech network. Work on abstract problems across functional areas of the business. Erroneous decisions will have a serious impact on the overall success of functional, divisional, or company operations. In addition, work independently on complex technical and managerial problems in which analysis of situations or data requires in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
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:
- Master's Degree in Science or Technical field;
- 12 years of experience in Biotech with 10 years in management positions;
- Method development, biotechnology principles, protein characterization, biotech process (fermentation/bioreactor, purification and drug product), broad cGMP experience and knowledge of regulatory compliance, ability to interact with and gain the support of senior management;
- Strong leadership and interpersonal skills;
- Skilled in achieving results and managing others to achieve functional/site/company objectives.
Preferred Qualifications: Your application
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. Country:
United States Location:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.