SUMMARY:

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 Pfizers 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.
You will be part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. You will be part of the manufacturing team focused on mammalian bio-processing, this includes and not limited to supporting the manufacturing operations team, reviewing Standard Operating Procedures, reviewing batch records, and standard work. As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing of previously acquired knowledge. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

MINIMUM QUALIFICATIONS:

• High School Diploma or GED
• A minimum of 0-3+ years of experience in a related role
• Demonstrated experience in a biotechnology manufacturing or laboratory environment
• Operational knowledge of computerized systems
• Familiarity with Production Control Systems, Enterprise Resource Planning Systems, and other business systems
• Maintains a safe work environment
• Demonstrated capability to work as a team member in a matrix development team
• Excellent oral and written communication skills
• Strong computer skills in Microsoft Office required, especially MS Word, MS Excel
• Understanding of scientific principles, ability to think critically, and demonstrate troubleshooting and problem-solving skills.

PREFERRED QUALIFICATIONS:

• Bachelor’s Degree
• Knowledge of cell culture and or downstream processing techniques in a manufacturing setting preferred
• Mechanical aptitude and desire to execute hands-on manual labor

• Manage own time and professional development, be accountable for own results and begin to prioritize own workflow
• Cross-functional communication with tech transfer team, quality and engineering as necessary
• Implement {Current} Good Manufacturing Practices {part of GxP} procedures and safe handling techniques for solid dosage processing within the continuous manufacture /PCMM work stream
• Perform Upstream and Downstream operations in clinical Bio-Manufacturing
• Ability to follow Standard Operating Procedures and work under minimal supervision
• Identify and support continuous improvement initiatives and root cause analysis tools
• Generate, assist, and execute documentation associated with solid dosage manufacture, such as, working batch record documentation, in-process run sheets
• Complete activities identified as Operator care tasks associated with the maintenance and operation of complex pharmaceutical manufacturing equipment
• Work in electronic systems, including QMS, Documentation, Laboratory Information Management System, Enterprise Resource Planning (e.g. SAP) etc.
• Actively participate in shift exchange activities and communication channels
• Complete training to take part in safety inspections within the facility
• Understand and comply with the policies, procedures, and working practices of Environment, Health & Safety, and where necessary contribute to the review and implementation of the practices in the plant.