AstraZeneca Pharmaceuticals LP PET Director (Sterile Ops Focus Factory) in West Chester, Ohio
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
The PET Director (Sterile Ops Focus Factory) is a leader for the Process Operation (i.e., Bulk/Fill / Packaging). In this capacity, the PET Lead oversees and leads the PET Operations to ensure high quality product in accordance with the
PET operating strategy. As a responsible leader for the PET, this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and AstraZeneca standards.
Provides direction to PET management/personnel in the efficient use of equipment
and materials to produce quality products in accordance with PET Planning
Responsible for all PET activity to include oversight of support staff, batch
scheduling and process improvement projects.
Promotes the use of safe work practices during all aspects of production and
ensures all external and AstraZeneca SHE standards are met on a daily basis.
Accountable ensure training of PET personnel on equipment, processes and
Standard Operating Procedures is met. Partners with PET Coach to develop
training plans and assist in providing resources for training.
Ensures that cGMP’s are used and followed during production of products so that all
FDA and international regulations are met. Responds to internal audit observations.
Promotes a positive work environment by effectively administering AstraZeneca
Human Resources policies and procedures including Performance Management
and by communicating information to employees and responding to their concerns.
Ensures proper documentation practices are maintained consistently to company
standards in manufacturing documents, training documentation, production logs,
Oversight for reports relative to functional area deviations, provides direction in
investigations, and recommends/implements solutions to resolve deviations.
Approves deviation investigations as appropriate. Respond to product defect
Authors, reviews, and approves Standard Operating Procedures and other
documents to ensure integration of cGMPs and improve process efficiencies.
Promotes and encourages continuous improvement in efficiency, quality, production,
and safety through the use of team driven processes and key performance
indicators and recognition and rewarding high performance.
Collaborates with PET Engineers, as applicable, to optimize process performance.
Participates in the design, selection, installation and qualification of new equipment,
facilities, and processes.
Consults, reviews, approves, and implements change control.
Provides career development and performance management for direct reports.
Co-owns life cycle management of PET/facility assets
Works collaboratively within and across PETs to ensure flow of product, sharing of
best practices, and lean behaviors.
Maintains presence across multiple operating shifts as appropriate.
Minimum Requirements (Education, skills and abilities)
Bachelor of Science in Engineering, Pharmacy, related Science or business.
Minimum 5 years experience in GMP or regulated production environment
Minimum of 5 years previous managerial experience.
Knowledge of FDA cGMP’s
Strong communication and leadership skills.
Problem solving skills.
Experience working in a LEAN manufacturing environment
Working knowledge of AZDOC-TDMS, Microsoft applications, SAP, Trackwise
Training or experience in formulation, filling, packaging, validation, technology
transfer, change control.
Knowledge or previous experience in managing technical programs/projects
Strong mechanical, electrical, troubleshooting and problem solving abilities.
Ability to direct and participate in cross-functional teams.
Project management skills
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.