Director of Aseptic Operations
- This position will be required to lead the Pfizer Kalamazoo aseptic drug product manufacturing function in a cGMP compliant environment. The leader will be responsible for providing strategic and managerial oversight to the manufacturing teams across Component Preparation, Product Formulation, Aseptic Filling, Freeze Dry, Biologic Active Ingredients, and Operations Compliance functions.
- This individual will cultivate and reinforce appropriate Pfizer values, norms, and behaviors and will provide oversight to individuals and teams on personal development, performance, and quality related issues.
- Direct the manufacture of aseptic drug products across three aseptic cores, ten formulation suites, twelve filling lines and twenty five freeze dryers, as well as all associated capital and product transfer project support.
- Ensure that the manufacturing departments are cGMP compliant.
- Ensure that the departments are staffed to meet production requirements.
- Embed and sustain IMEX processes and tiered governance, empowering teams to deliver continuous improvement and operational performance. Support and foster Supportive Leadership among people leaders within Aseptic operations through active coaching
- Creates/monitors department’s budgets. Monitors, reports and reacts accordingly to production variance reports.
- Ensures a safe manufacturing environment is in place.
- Ensures that all manufacturing methods and practices are consistent with industry and Pfizer standards.
- Ensures that colleague training programs are suitable and effective to support cGMP requirements.
- Drive effective CAPA at key suppliers to improve quality compliance and efficiency of componentry.
- Write and deliver performance reviews and perform second level reviews as required.
- Timely escalation of personnel, environmental, safety and manufacturing issues.
- Provide strategic direction for operations master planning, preparation of business justifications with direct input to capital investments, and oversee product transfers.
- 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. Note that these activities may not be time bound to core hours or presence at the site.
- Bachelor’s degree in Engineering, Science, Business or equivalent
- 10 years of directly related experience and at least 5 years in an aseptic drug product manufacturing environment
- Minimum of 5 years of leadership experience directing and developing colleagues
- Strong analytical, presentation and relationship management skills
- Experience in aseptic drug product processes
- Excellent verbal, written and presentation skills
- Demonstrated innovation and continuous improvement of work processes and deliverables
- Proven track record of delivering results consistently while being a role model for the Pfizer Leader Behaviors.
- Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Aseptic Gowning (to at least Grade C)
Off-shift and weekend work may be required as operations are 24x7
- Other Job Details:
- Last Date to Apply for Job: October 25, 2021
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Manufacturing#LI-PFE