Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will be part of a multi-disciplinary team responsible for cGMP (current Good Manufacturing Practices) production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. Your initial focus is on the start-up of a new facility in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training of operations staff. After the start of the facility, you will transition to a team that will be responsible for the execution of microbial upstream and downstream processes.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

 It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Support completion of Good Manufacturing Practices {also cGMP} documentation.
• Execute and troubleshoot downstream mammalian and microbial purification processes in a cGMP {part of GxP} environment.
• Support tech transfer activities for new products and product changeover for operations team.
• Identify and support the resolution of quality concerns and contribute to the subsequent investigational reports within the quality system.
• Make recommendations for continuous improvement opportunities with regard to safety, quality, and efficiency.
• Assist with associated tooling, change parts and perform in-process operational checks associated with clinical manufacturing.
• Work in electronic systems including QMS, Documentation, Laboratory Information Management System Enterprise Resource Planning (e.g.: SAP) etc.
• Understand data integrity principles and application within systems.
• Work on supporting and troubleshooting of process equipment and Clean-in-place (CIP) and Steam-in-place (SIP) operations.

Qualifications

Must-Have

• Bachelor's Degree with 3+ years of experience or Masters Degree with 1+ years of experience
• Experience with Tech Transfer, Facility Fit assessments and engineering design
• Demonstrated experience in a biotechnology manufacturing or laboratory environment
• Ability to execute against Standard Operating Procedures and document entries in a compliant manner
• Demonstrated capability to work as a team member in a matrix development team.
• Maintains a safe work environment
• Excellent oral and written communication skills
• Strong analytical and computer skills

Nice-to-Have

• Prior experience in a Biological Pilot Plant or Commercial Manufacturing setting

  
Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.