Technical Expert, Clinical Manufacturing, Fermentation

ROLE SUMMARY

At Pfizer, we innovate every day to make the world a healthier place. It was the vision of Pfizer at the very beginning and it holds true today in everything we do. From scientific discovery to breakthrough products to our essential partnerships around the world, we’re committed to quality healthcare for everyone. Because every individual matters. Our medicines and vaccines save or improve countless lives and our consumer products empower people to take care of themselves. Pfizer Corporate Responsibility believes that all individuals, everywhere, deserve access to quality healthcare and the opportunity to lead healthy lives.

Diversity, equality and inclusion are an integral component of Pfizer's mission to build a vibrant culture. We maintain the highest standards of ethics and compliance in all of our business practices.

This Technical Expert 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.

The initial focus of this role will be part of the Fermentation suite startup team to prepare the facility for operational readiness. This includes and not limited to support interviewing of manufacturing operations team, develop training, SOPs, batch records, and standard work. May also include commissioning and qualification of process equipment.

ROLE RESPONSIBILITIES

• Lead manufacturing operations on the production floor.
• Ensure all safety and compliance procedures are followed at all times.
• Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
• Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
• Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
• Serve as SME for Fermentation cell culture operations.
• Provide training to manufacturing staff on process and equipment.
• Own Non-Conformances (NC) and Corrective and Preventive Actions (CAPA), facilitate the drive towards continuous improvement in all Manufacturing areas.
• Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
• Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
• Participate in the design, development, and implementation of processes in support of the manufacturing floor.
• Effectively uses process automation systems (i.e. Delta V and OSI/Pi Historian) and supporting business systems (i.e. Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc.)

BASIC QUALIFICATIONS

• HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent.
• Requires a minimum 5+ years of experience in a biotechnology manufacturing or laboratory environment.

PREFERRED QUALIFICATIONS

• Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting
• Prior experience of mammalian cell culture and/or microbial fermentation, harvest, chromatography and TFF processes.
• Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)
• Experience with Quality Management and Change Management Systems (i.e. Trackwise)
• Ability to follow Standard Operating Procedures and work under minimal supervision.
• Strong mechanical aptitude and ability to interface with computerized systems required.
• Demonstrated capability to work as a team member in a matrix manufacturing team.
• Excellent verbal and written communication skills

Other Job Details:

• Eligible for Relocation Package: NO
• Eligible for Employee Referral Bonus: YES
• #LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.