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.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio.  In addition to serving as the global COVID vaccine production site for AstraZeneca , the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines.  Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world.    We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves.  Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events.

The Senior Manager will lead the development and implementation of strategies to improve overall performance over time and influence the strategic direction for a Process Execution Team (PET). They may act as a representative for the manufacturing function within AstraZeneca on projects and working teams. They have primary responsibility for the personnel, facilities and equipment within a PET operating area. This may include personnel responsibilities across multiple shifts and responsibilities to provide direction to Process Facilitators within the PET to optimize quality and performance of the operation. They will be responsible for independent decision making for operations within the PET in the absence of or in support of the PET Lead. As a responsible leader, they must maintain effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and AstraZeneca standards.

What you'll do:

• Provide direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with the PET Plan or Rhythm Wheel.
• Responsible for all PET activity to include coordination of support staff, scheduling, and improvement initiatives. This coordination may be across shifts and across Process Facilitators directly reporting to this role. This individual must have the ability to manage large groups and meet performance management goals.
• Mentor and coach Process Facilitators on individual and team development.
• Provide assistance to the PET Lead during the PET budgeting process and provides financial analysis as requested by the PET Lead.
• Promote the use of safe work practices during all aspects of production and ensures all external and AstraZeneca Safety, Health, and Environmental (SHE) standards are met on a daily basis.
• Accountable to ensure adequate level of training for PET personnel on equipment, processes, SHE, and Standard Operating Procedures. Partner with PET Coach to develop training plans and assist in providing resources for training.
• Ensure that cGMP’s are used and followed during production of products so that all FDA and international regulations are met.
• Ensures timely responses to internal and external audit observations.
• Promote 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.
• Ensure proper documentation practices are maintained consistently to company standards in manufacturing documents and training documentation.
• Ensures PET reports for deviations and recommended/implemented solutions to resolve deviations are completed in a timely fashion. Approves deviation investigations and responds to product defect notifications as appropriate.
• Promote and encourage continuous improvement in efficiency, quality, product delivery, and safety through the use of team driven processes, key performance indicators, and recognition and rewarding for high performance.
• Collaborate with OE Engineers & PET Engineers to optimize process performance.
• Participate in the design, selection, installation, and qualification of new equipment, facilities, and processes.
• Provide career development and performance management for direct reports.
• Co-own life cycle management of PET/facility assets
• Work collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.
• Perform roles for PET Lead when designated.

Essential for the role:

• Bachelors degree required in Administration, Business, Engineering, Pharmacy, or related Science.
• Minimum 8 years’ experience in GMP or regulated environment.
• Minimum of 5 years supervisory experience.
• Knowledge of FDA cGMP’s.
• Strong communication and leadership skills.
• Problem solving skills.

Desirable for the role:

• Experience working in a LEAN manufacturing environment.
• Working knowledge of Microsoft applications, SAP, and Track wise.
• Training or experience in formulation, filling, packing, validation, and technology transfer, Knowledge or previous experience in managing technical programs/projects.
• Strong mechanical, electrical, troubleshooting, and problem-solving abilities.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.