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Manufacturing Manager (Packaging) - Operations

Location Newark, Delaware, United States Job ID R-157397 Date posted 23/01/2023

AstraZeneca is at an exciting time of new products and launches. We get to work with innovative and scientific products on our leading-edge end-to-end supply chain, using the latest technologies and modern facilities.

The AstraZeneca Newark Supply Site was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for the global supply of complex products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. To help maintain your best self, here’s a sneak peek into some of the things this site provides: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and a dining center.

The Manufacturing Manager is a leader for the Process Operation (ie. packing lines or unit operations) and provides oversight of several process operations (ie bottle/blister packing, roller compaction, coating). As the Manufacturing Manager, you will manage the Process/Package Operation to produce high quality product in accordance with the Process Execution Team (PET) operating strategy. As a responsible leader for the operation (potentially with other Manufacturing Supervisors/Managers), 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.

Specific to Oral Powder Packaging Line, the Manufacturing Manager is responsible for the creation and capability uplift of the team members that will support the design, testing and implementation of the new sachet lines for Newark.

What you'll do:

During Design & Implementation Phase:

  • Active participation and engagement on equipment and process design. Ensuring process is suitable and can be maintained once moving into commercial operations.

  • Recruitment and creation of teams supporting the designed operation model for the sachet lines units.

  • Creation of SOPs and documentation according to cGMP’s and site safety procedures.

  • Assist in the (re)qualification and (re)validation of processing equipment by supporting engineering in protocols and testing. As well as participates on factory acceptance test as per required.

  • Create training curricula and documentation to onboard new team members.

  • Training activities for knowledge transfer for new team members.

  • Identify areas for continuous improvement and efficiency improvements and actively participate in Kaizen/SMED events. 

During Operations:

  • 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 other Process Facilitators within the PET.  

  • Provide assistance to the PET Lead during the PET budgeting process and provides financial analysis as requested by the PET Lead, PMFC or support staff.

  • Provide ownership of the Technical Processes within the PET to include but not limited to those complex technologies such as Inspection and Vision Equipment, Bottle Packaging, Blister/Wallet Packaging and Solid Oral Dosage Manufacturing.

  • Promote and demonstrate 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 for training of PET personnel on equipment, processes and Standard Operating Procedures.  

  • Ensure proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.

  • Authors deviation investigations, generate reports for deviations, assist in the investigations, and recommend/implement solutions to resolve deviations.  Approve deviation investigations as appropriate.  Respond to product defect notifications.

Qualifications:

Essential:

  • Bachelor of Science in Engineering, Pharmacy, related Science or business.

  • Minimum of 3-5 years of experience in GMP or regulated production environment

  • Previous supervisory experience.

  • Knowledge of FDA and cGMP guidelines

  • Effective communication and leadership skills

  • Problem solving skills

Desirable:

  • Experience working in a LEAN manufacturing environment

  • Working knowledge of  Microsoft applications, SAP

  • 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

Why AstraZeneca

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

So, what’s next

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Find out more on Social Media:


    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.

    AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

    10000523 E MNMM

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