Pfizer Director, STL Laboratories (Chemistry, Microbiology and Environmental Control) in St. Louis, Missouri
Leads the site's Chemistry, Microbiology and Environmental Control Laboratories.
Ensures that the site's Chemistry, Microbiology and Environmental Control laboratories meet defined quality standards, objectives and regulatory commitments.
Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes.
Collaborates with responsible colleagues to ensure qualification/verification, calibration and maintenance of laboratory equipment and test methods are complete and meet quality standards.
Ensures the integrity of laboratory documentation and data
Ensures that laboratory investigations and notifications to management meet quality standards and procedural requirements.
Ensures inspection readiness of the laboratories and manages interaction with customers and regulatory inspectors in the laboratories.
Fosters teamwork and colleague development.
Provides guidance and coaching to laboratory colleagues and provides direction/approval of activities and decisions.
Ensures proper use and short/long term planning of assets, budget, and personnel.
Establishes the annual budget for the relevant laboratories.
Ensures that contracts and statements of work are maintained for external vendors.
Ensures collaboration and common practices where applicable within the Chemistry, Microbiology and Environmental Control laboratories as well as with the other site laboratories .
Collaborates and consults with appropriate Center groups to ensure alignment with Corporate and/or Divisional requirements regarding corporate guidelines, best practices, and reporting requests.
" Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."
BA/BS in a life science. MA/MS or MBA preferred.
Minimum of 10 years of experience in pharmaceutical laboratories. Preferred sterile injectable, medical device and/or combination drug/device experience. Experience in Quality Assurance preferred.
Minimum of 5 years QC management experience in a cGMP environment with demonstrated success in directing and developing colleagues.
Position requires regular onsite attendance -this position cannot be performed on a remote or telecommute basis on a short or long term basis. Most work will be accomplished working from the office desk, and attending meetings. Walking within the office areas, manufacturing facility as well the laboratory area. May require traveling from one site campus to another (approx. 11 miles apart). Ability to travel (limited basis).
While performing the duties of this job, the employee is occasionally exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and/or move up to 25 pounds; specific vision abilities required by this job include ability to adjust focus.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays. Individual must be safety conscious and be willing to work in a team environment.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.
Other Job Details:
Last Date to Apply for Job: January 20, 2021
Eligible for Relocation Package: Yes
Eligible for Employee Referral Bonus: Yes
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EEO & Employment Eligibility
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Quality Assurance and Control