Job Description
Why Patients Need You
The incumbent will be responsible for management of the manufacturing process supporting 2 line operation in purification in a multi-product cGMP facility capable of manufacturing commercial, clinical mammalian product drug substance.
The senior manager of manufacturing operations is responsible for management of all operational personnel working in the facility whose primary focus is on the execution of manufacturing processes, technical assessment of processes including technology transfer, maintaining a culture of compliance, innovation, and continuous improvement within their assigned Asset Group.
The senior manager will be expected to coach and guide the people in their group on the following:
Current cGMP procedures and expectations
Creating and maintaining a culture where adherence to Pfizer Quality and Compliance is non-negotiable
Process and technical knowledge to ensure right first time execution of GMP operations
Lead troubleshooting activities, provide investigations support, analyze process data, and identify and implement process improvements and a culture of continuous improvement.
This is a senior and highly visible position. The ideal candidate will be expected to engage within their own organization as well as peers in other assets and senior site leadership at the site level.
How You Will Achieve It
Oversight of a production group for 2 line operation in purification/ buffer and glass wash area of ~56 people, including a mix of both exempt and non-exempt colleagues
The person will have 4 shift PLs reporting to them and could also have 1-3 individual contributors reporting to them. Responsible for coaching/mentoring both technical and non-technical staff. Establishes tactical activities for hourly and/or professional staff to support day to day operational goals.
Guide people in their group with process and technical knowledge to lead troubleshooting activities, provide investigations support, analyze process data, and identify and implement process improvements and a culture of continuous improvement.
Strong understanding of industry knowledge (GMP regulations applicable) and has a developed understanding of business operations.
Represent Suite CD asset at the IBP demand and supply meetings-provide capacity assessment, understand training gaps and operational readiness for 0-24 month POR look ahead
Work with Tech transfer, EMU and STS groups to understand Operational readiness and facility readiness and execute to plan.
Understanding and exposure to IMEx management system is a plus
Actively shares knowledge with others across assets through existing knowledge sharing processes/systems.
Across the manufacturing assets, identifies and makes improvements to existing work processes/products. Learns to take appropriate risks and applies ingenuity
Working with their staff solve complex problems within area of responsibility and on cross-functional teams outside immediate area of expertise
Supports developmental and training opportunities for direct reports.
Responsible for coaching/mentoring both technical and non-technical staff.
Encourages the participation and perspectives of all team members. Effectively listens to and explains difficult issues to reach shared understanding and building alignment.
Builds alignment across manufacturing assets. Regularly interacts with key stakeholders including Engineering, Quality, Technical Services, and Operational Management departments.
Decision making autonomy within their direct team. Decision escalated when impact has significant impact on department.
Demonstrates effective written and oral communication skills. Ensures timely flow of information to appropriate individuals.
Recognizes and helps to manage change that impacts multiple areas/assets.
BASIC QUALIFICATIONS
BS in an Engineering or Science discipline with 10+ years or MS in an engineering or Science discipline with 9+ years in relevant experience or PhD with 7+ years relevant experience
Knowledgeable in cGMP operations processes involved in the production including buffer preparation and glass wash operations , purification, UF/DF and final product filling
Knowledgeable/experienced with DMAIC processes, investigation processes, and automation a plus.
PREFERRED QUALIFICATION
Previous experience in a cGMP environment and management experience required
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
Gowning required to enter suite
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
No travel anticipated
Relocation support available
Work Schedule: 8am-5pm
OTHER JOB DETAILS
Last Date to Apply for Job: June 9th, 2023
Eligible for Relocation Package – YES
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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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.
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.