Process Lead

Responsible for the operation of upstream, downstream, and central services processing equipment according to established SOPs, the Process Lead drives continuous improvement opportunities. As the operational subject matter expert, you will represent the shift and/or functional area as needed for investigations, CAPAs, and receipt of tech transfer information. Your decisions will have long-lasting effects and influence the future course of the organization. Errors in judgment or failure to achieve results could result in significant expenditure of company resources and/or loss of batch(es).

Accountabilities

• Direct on-floor support:
  - Qualified to support on-floor coaching
  - On the floor manufacturing execution as needed by shift supervisor
  - Shift representative for shop floor investigations and CAPA execution

• In-direct floor support:
  - Trend process performance and data trending to assess batch performance
  - Lead and engage in continuous improvement projects
  - Author, review, and approve batch records and direct SOPs for manufacturing
  - Final review of completed manufacturing documentation per compliance standards and established timelines
  - Logbook reviews, where applicable
  - Assess training competency of and provide training to shift personnel
  - First line of defense for process and equipment troubleshooting on the shift
  - Identify and execute standardized work and process improvements

• Other duties as assigned or identified
• Demonstrated expertise in hands-on manufacturing operations
• Expert processing equipment knowledge to perform or assist in investigations and CAPA execution
• Demonstrated understanding of manufacturing processes with the ability to trend performance to identify unexpected excursions or trends
• Develops solutions to complex problems requiring ingenuity and creativity/innovation
• Ensures solutions are consistent with the organization’s objectives
• Ability to apply investigation and troubleshooting methodology to perform investigations and recommend CAPAs
• Deep problem-solving skills
• Strong influencing skills
• Decision-making skills

Essential Skills/Experience

• Minimum of 4 years (with Bachelors) biotechnology or pharmaceutical industry experience in process development, manufacturing, or similar role;
• 5 – 7 years with Associates
• 7+ years with high school diploma

Desirable Skills/Experience

• BS/BA degree in relevant field preferred; AS degree in relevant field plus experience acceptable

At AstraZeneca, we lead our Operations function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients. We ensure everyone's voice is heard on site, building trust and respect with our teams. Adaptable and agile, we draw on the diverse expertise of our teams, working cross-functionally to overcome any obstacles. We inspire our teams with ambition and initiative, ensuring everyone has a platform to share their ideas.

Join us in making a difference! Apply now to be part of our journey.

The annual base pay (or hourly rate of compensation) for this position ranges from $91,703.00 to $137,555.00 Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors

Date Posted

14-Jul-2025

Closing Date

27-Jul-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.