Sr. Manager, Site Technical Services
Pfizer Inc.
Washington – Bothell, NY
Job posting number: #7267416 (Ref:pf-4911486)
Posted: July 26, 2024
Job Description
Why Patients Need You
Provide technical expertise in all areas in support of the site goals of being clinical and commercial site for recombinant proteins and antibody drug conjugates products and a technical leader in the area biologics manufacture. Lead troubleshooting efforts directed at technically complex issues that arise in manufacturing processes. Lead complex projects to address issues and develop and implement new technologies. As member of the site senior leadership team participate in developing short- and long-term strategies for the site. Lead efforts in the area of technology transfer, validation, informatics and process monitoring Lead effort in developing strategies around technologies and advanced manufacturing options. Directs the efforts of assigned staff in compliance with all regulatory requirements, cGMPs and company policies, procedures and goals.
What You Will Achieve
Assures the appropriate interaction of all required group, including Quality, Operations, Engineering & Maintenance, Materials Management, Regulatory Affairs.
How You Will Achieve It
The Site Technical Services group is responsible for the following:
Tech transfer of processes into and out of the North Creek
Site validation of equipment and systems, as well as process validation of new processes and process changes.
Oversight of the informatics program including multi variant analysis, process monitoring, continuous process validation and database management in partnership with IT groups
Providing technical support and leadership on highly technical, complex process issues. Evaluation and introduction of new and PAT enabling technology
The Site Technical Services Director (STSD) participates as a fully active member of the Pfizer Global Supply (PGS) North Creek site leadership team. The STSD has responsibilities for delivering on the site strategy via sponsorship and leadership of both functional and cross functional projects and is expected to be an active participant on all cross-site teams.
Other responsibilities include:
Manages and leads all aspects of Site Technical Services and is accountable for setting the strategic direction for the function and ensuring its alignment with both the site and the network.
Has accountability to lead the budget and resource planning process for the function.
Develops ways of working that will support and contribute to the site safety efforts and will meet all required environmental and industrial hygiene requirements
Sets the objectives for his/her leadership team.
Advances the functions use of Right First Time/Six Sigma/ Innovation problem solving methodologies and leads efforts to advance Operational Excellence tools and innovative solutions.
Acts as the site point of contact with external stakeholders, providing technical/site and leadership input into these site teams.
Provides a platform of open communication within the function and the site, and also between the site and the network/business.
Actively develops relationships within Pfizer and establishing relationships outside of Pfizer that will be beneficial to the site and PGS performance.
Supports and actively collaborates with Quality, Manufacturing, and Regulatory to meet the increasing expectations of Board of Health inspections, and when necessary, supports regulatory submission.
Has responsibility for Site Technical Services talent planning and development that includes coaching and mentoring, development and performance management.
Embraces and demonstrates leadership in our cultural journey, has change management abilities and brings innovative ideas to increase awareness, participation and engagement.
BASIC QUALIFICATIONS
BS in a scientific or engineering discipline required.
15+ years of pharmaceutical or cGMP manufacturing experience required.
10+ years of experience in the field of biological production process, cell culture, and protein purification required.
5+ years of direct management experience, including demonstrated experience leading technically complex projects and senior level scientist and engineers, required.
Must have administrative, managerial skills, technical report writing, computer, and presentation skills.
Working knowledge of the relevant portions of cGMP regulation is required.
Demonstrated 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.
Demonstrated ability to communicate and interact across functional and divisional boundaries.
Demonstrated leadership skills including effective team and individual development.
Demonstrated ability to operate in a “matrix” organizational environment, transcending organizational boundaries, while leading change and delivering innovative solutions to the business.
Demonstrated ability to seize accountability, to hold people responsible, and to act decisively.
Demonstrated use of Operational Excellence techniques leading to achievement of best-in-class organization
OTHER JOB DETAILS
Work Location Assignment: Flexible
Last Day to Apply: August 6th, 2024
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
