Technical Specialist, Clinical Manufacturing

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

The clinical manufacturing technical specialist is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The initial focus of your role will be on the start-up of a new facility in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training within the production support area. You will be part of a team responsible for the execution of upstream mammalian and microbial processes. You will coordinate and lead production operations on the manufacturing floor, including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.

As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

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

• Manage own time, professional development, and be accountable for own results.

• Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.

• Adhere to Good Manufacturing Practices and standard operating procedures, and material sampling instructions.

• Execute downstream mammalian and microbial purification processes in a {Current} Good Manufacturing Practices {part of GxP} environment.

• Responsible for the equipment preparation, formulation and filling of biologic drug products.

• Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.

• Identify opportunities for continuous improvements and enable implementation, utilize continues improvement and root cause analysis tools.

• Maintain cross-functional communication with tech transfer team, quality and engineering.

• Perform troubleshooting of production support equipment and operations.

• Understand scientific principles in order to problem solve and troubleshoot test results.

• Report any deviation or observation that might lead to adverse impact to product quality.

• Complete work instructions and maintains clean room environment to comply with regulatory requirements.

Qualifications

Must-Have

• High School Diploma or GED.

• 2+ years of experience.

• Certification in assigned area, if applicable.

• Demonstrated experience in a biotechnology manufacturing or laboratory environment.

• Experience in cGMP (Current Good Manufacturing Practices) compliance as related to manufacture of biologics.

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

• Strong workload planning skills, organization, and attention to detail, and follow through.

• Excellent written and verbal communication skills.

• Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel.

Nice-to-Have

• Bachelor's Degree.

• DS Purification experience.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include full coveralls, face mask, head cover, boots and gloves.

• Ability to lift up to 25 lbs.

• Ability to stand and walk for extended periods of time.

• Ability to operate forklift or Master Mover for heavy loads.

• Ability to perform algebraic mathematical calculations and follow Standard Operating Procedures.