AstraZeneca Pharmaceuticals LP Process Lead-Operations in Frederick, Maryland

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.

Main Responsibilities

Scope:

Responsible for operation of upstream / downstream / central services processing equipment according to established SOPs and driving continuous improvement opportunities. The Process Lead is the operational subject matter expert to represent the shift and/or functional area as needed for investigations, CAPAs, and receipt of tech transfer information. The position reports to the area manager with dotted-line responsibilities to the shift supervisor to support daily manufacturing and in-direct floor support activities which include:

  • Direct on floor support (50-70% time on shop floor)

  • Qualified in Lead Technician duties and 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 (30-50% time for 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

Knowledge:

  • 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 ability to trend performance to identify unexpected excursions or trends

Problem Solving

  • Develops solutions to complex problems requiring ingenuity and creativity/innovation

  • Ensures solutions are consistent with organization’s objectives

  • Ability to apply investigation and troubleshooting methodology to perform investigations and recommend CAPAs

Freedom to Act:

  • Work is reviewed for soundness of judgment and overall quality and efficiency

  • Exercises considerable latitude in determining objectives and approaches to assignment

Impact:

  • Effects of decisions are long-lasting and influence the future course of the organization

  • Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources and/or loss of batch(es).

Interpersonal Communication:

  • Contacts are frequent with individuals representing other departments

  • Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation

Supervisory/Management Skills:

  • Deep problem solving skills

  • Strong influencing skills

  • Decision making skills

Education/Experience

  • BS/BA degree in relevant field.

  • AS degree in relevant field plus experience acceptable

  • Minimum of 5 - 7 years (with Bachelors) biotechnology or pharmaceutical industry experience in process development, manufacturing, or similar role; 8 – 10 years with Associates

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.

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.