Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Senior Manager QC Stability

Your tasks and responsibilities

 

The primary responsibilities of this role, Senior Manager QC Stability, are to: 

 

  • Manage the design, execution and technical oversight of commercial stability programs for several protein pharmaceutical products in line with Bayer directives, ICH guidance, and global regulations;
  • Design and manage investigative stability programs for several protein pharmaceutical products and supporting various process improvement initiatives in line with Bayer directives, ICH guidance, and global regulations;
  • Establish new, and improve existing standards and controls programs ensuring alignment with laboratory SME, laboratory managers and written SOP;
  • Implement processes for tracking the life cycle management of these standards and controls;
  • Provide strategic technical guidance and management support for all stability operations and related discrepancies, corrective and preventative actions;
  • Collaborate effectively with QA representatives to manage the initiation, investigation, and closure of discrepancy events;
  • Represent the organization at outside stability benchmarking groups or consortiums;
  • Summarize and evaluate stability data and control trending using statistical analyses software like JMP. Author Quality Control technical reports;
  • Prepare Stability sections for regulatory submissions;
  • Interact directly with internal as well as external auditors/inspectors from governmental regulatory agencies, and partners/suppliers;
  • Build relationships with various internal stakeholders inside the QC, QA, and regulatory affairs organizations as well as with external customers to streamline processes across the organization, implement improvements, and facilitate communication;
  • Actively manage laboratory operations associated costs and ensure compliance with cost center goals;
  • Identify opportunities to reduce costs and operate more efficiently, and make recommendations to management;
  • Ensure that all stability, standards and controls group personnel are properly trained and adhere to their training plans; ensure compliance with programs and adherence to GMP and health, safety and protection of environment;
  • Provide effective leadership including, individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area, and supporting workforce diversity and quality.

     

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 in a science or technical field;
  • Six to eight years of experience in pharmaceuticals or a related industry with three or more years in management positions; OR
  • An equivalent combination of education and experience;
  • Working knowledge of cGMP and regulatory compliance (US and other international agencies);
  • Experience with Stability Program management and data evaluation per ICH Guidance;
  • Experience with stability indicating analytical methods such as Chromatography, potency assays, Gel Electrophoresis, binding assays;
  • Experience with statistical data analysis and trending software such as JMP;
  • Strong leadership, interpersonal, communication and team building skills;
  • Ability to multi-task and good adaptability to changing business requirements in a dynamic corporate environment;
  • Experience with LIMS.

 

Preferred Qualifications:

 

  • M.S. preferred.

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: CA-Berkeley