Pfizer Hiring BSc & MSc Biochemistry & Biotechnology Candidates – Associate Post

Pfizer Hiring BSc & MSc Biochemistry & Biotechnology Candidates

Pfizer is hiring candidates with Bachelor’s Degree or Master’s Degree in biochemistry, biotechnology for the post of Sr. Associate in Process Technology at North Carolina – Sanford united states. Intrested and eligible candidates may check out all the details on the same below:

Job Title: Process Technology Sr. Associate

Location: United States – North Carolina – Sanford

Eligibility Criteria: 

Bachelor’s Degree or Master’s Degree in biochemistry, biotechnology, chemical engineering, or equivalent science-related field or engineering discipline

Experience: 3-5 years of demonstrated experience in process or quality engineering in a pharmaceutical / medical device setting

• Demonstrated technical capability and aptitude for technical learning
• Sound understanding of statistical experimental design and analysis
• Familiarity with the operation of cell culture and/or purification technology
• Ability to work on own initiative
• Excellent communication skills and fluency in English

Preferred 

Master’s degree, 2+ years Relevant pharmaceutical experience

• Experience with AAV manufacturing or mammalian cell culture
• Previous experience executing as a Technical Services Scientist {Product transfers and Process validation experience}
• Validation and analytics knowledge
• Basic knowledge of Delta V

What You Will Achieve at Pfizer

• The incumbent works as part of a team to perform scientific, operational and process engineering tasks as they relate to technology transfer, scale-up operations, capital projects and routine manufacturing support. The incumbent should have the cross-functional scientific ability/skills/knowledge to work in any of the gene therapy production areas including cell culture and purification. Although the incumbent may be hired to work primarily in a particular area, they are expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance pipeline projects.
• The incumbent works with some direct supervision and is responsible for executing optimization, implementation, troubleshooting, tracking, and reporting of a variety of manufacturing processes for clinical and commercial production of gene therapy drug substances. The incumbent must also be able to maintain GMP documentation essential and document the manufacture of clinical and commercial grade material. The incumbent must comply with applicable safety, occupational health, loss prevention and environmental requirements.

How You Will Achieve It

• As AAV gene therapy products progress to commercial manufacturing, the incumbent will work with Operations, Quality, Process Engineer, Manufacturing Science & Technology, and other groups to support the manufacturing process as the technical lead. This includes the following:
• Review, recommend and execute process improvements and optimizations to existing processes with engineering principles (i.e. cycle time reduction, equipment efficiency, PAT, CPV, APR). Analyze root causes of process problems including but not limited to equipment failure, instrument malfunction, automation changes, and recommend technical solutions. Develops guides and executes implementation of solutions to complex process engineering problems.
• Coordinates the development and execution of studies to identify, resolve and/or correct manufacturing problems or process improvements, producing reports to substantiate findings, and establish validation acceptance criteria.
• Support and enhance the technical capability of the manufacturing environment including process control and improvement. Implement process control and reporting tools to ensure process trends are reviewed in a timely manner
• Serves as the technical support for commercial products by serving as the point of contact for manufacturing. Ensures relevant technical information is relayed to group members and manufacturing colleagues and solicits this personnel for feedback and improvement. Works with manufacturing to ensure production efficiencies.
• Understand and provide input to the development of detailed process flow diagrams and step-by-step process fits of unit operations. May create, edit and maintain SOPs, Master Batch Records and Compounding Records as needed for commercial production within the approved QA document management system. Lead the revision process of documents as needed
• Collaborate with development personnel during engineering practice runs. Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, Master Batch Records, and Compounding Records. Provide suggestions for innovative approaches to scale-up issues related to new projects. Incumbents must be able to recognize unique differences among different gene therapy processes and contribute to the scientific team that works through the issues encountered. The incumbent is aware of new process parameters co-developed with colleagues and is able to introduce them into the process with area champion or supervisor input.
• The incumbent interacts with all functional groups at the site but would have primary interactions with engineering, manufacturing science, and technology (MSAT), manufacturing, and quality. The position also interacts with contacts at other PGS sites and center functions as well as PharmSci for new product/tech transfer activities.
• Participates in all internal and external audits related to validation activities.
• Takes a leadership role in cross-functional teams to resolve problems to optimize output, minimize contamination, and minimize cost.
• Interact with Manufacturing Operations, Engineering, and Product Development groups to proactively assess people/facilities capabilities and capacity
• Provide day-to-day support for technical issues in Mfg

Pfizer Hiring BSc & MSc

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