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Associate Director, Microbiology

Date: May 22, 2019

Location: Irvine, California, US, 92618

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Teva is searching for an Associate Director, Microbiology to join our team in Irvine!

The Associate Director is directly responsible for the direction and management of the Microbiology Department functions including microbiological assays related to product release, product sterility testing, method transfer protocols/validations, and environmental monitoring program.

You will:

  • Ensure that all the activities of the Microbiology lab (i.e., environmental monitoring/sterility assurance, product release testing such as bioburden, endotoxin, and bacterial identifications, etc.) are executed in a timely and efficient manner. 
  • Design and direct the implementation of the environmental monitoring program for clean rooms, provide upper management with environmental trends and apprise them of deviations from established trends. Direct the implementation of appropriate corrective actions.
  • Provide strategic direction on areas of Microbiology, Aseptic Processing Environmental Monitoring and Contamination Control expertise and guidance for the site and global projects. Provide subject matter expertise for corporate procedures.
  • Participate in and interact with Global Corporate Quality teams (Risk assessment audit, Quality enhancement).
  • Act as company expert for aseptic processing, media fills and environmental monitoring and write policy documents in these areas, as required. Design and implement the media fill program to meet all regulatory and corporate guidelines and provide summary reports and media fill trends to upper management.
  • Lead and support investigations for microbial contamination events and establish root cause and CAPA.
  • Provide guidance and technical expertise to Microbiology personnel in all functional areas. Develop action plan for streamlining activities of the department and increase personnel efficiency. 20%
  • Direct and manage personnel developmental plans for employees, and perform performance appraisals, issue warnings and take disciplinary actions as required.
  • Oversee Operational Excellence (OPEX) program for Microbiology/EM – including new technologies
  • Direct the establishment and implementation of departmental policies in accordance with corporate and regulatory guidance.
  • Review regulatory guidance, compendial requirements and other relevant technical documents to identify and implement changes and current trends in the industry.
  • Interact with auditors and participate in audits/inspections (internal/external).  Respond to observations/deficiencies from the audits/inspections.  Assist in the preparation of regulatory submissions by compiling Microbiology related information. 
  • Prepare, administer, and manage the department budget, and assist senior management in setting departmental goals.             
  • Manage the Microbiology department activities to ensure compliance with cGMP, FDA and other regulatory agency requirements.  Assure no major compliance issues due to Microbiology department.
Qualifications
  • Bachelor’s degree in Microbiology or Biological Sciences required, Master’s degree in Microbiology or Biological Sciences preferred.
  • Minimum 10+ years of experience in Microbiology or relevant QC experience in aseptic processing or biologics required.
  • Experience with Operational Excellence, Lean Lab concepts and being a SME during regulatory inspections required.
  • Strong relevant experience in executing, developing, and managing QC Microbiology and EM programs in cGMP biotech and/or pharmaceutical environments required.
  • 10-15 years of experience in Microbiology in aseptic / sterile processing or related industry required.  A minimum of 5 years of leadership/supervisory experience is preferred
  • In-depth knowledge of cGMPs, GLP, FDA and EMEA guidelines, USP, EP and BP microbiological test methods required.
  • Thorough knowledge of Microbiological methods, aseptic processing, biologics, media fills, sterilization, environmental monitoring and quality systems required. Ability to evaluate new aseptic processes and technology for implementation.
  • Proficient in performing trending and analysis of data using statistical tools.
  • Must have good interpersonal skills - be able to interface with all levels of management, peers and subordinates, and be able to build good working teams using excellent verbal and written skills.
  • Ability to drive to build a center of excellence and lab of the future, direct and manage a personnel developmental plan for all Microbiology employees.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Irvine California
Nearest Secondary Market: Los Angeles