Use Your Power for Purpose
Pfizer’s North Creek Manufacturing Facility is clinical and commercial biologics manufacturing facility producing antibody and antibody drug conjugates for life-altering cancer treatments.
The North Creek facility is seeking a highly motivated Technical Services, Sr. Manager that desires an opportunity to significantly contribute to the development and commercialization of transformative cancer therapies. The focus of this role is to support the transfer of Antibody Drug Conjugate (ADC) production processes to and from the North Creek Facility and to provide technical and validation support to ongoing GMP manufacturing processes. Lead troubleshooting efforts directed at technically complex issues that arise in manufacturing processes and develop and implement new technologies. The ideal candidate will have conjugation and downstream production experience in a GMP manufacturing environment and have can-do attitude and thrive in a high-paced environment, in a role of constant learning and change. This role also requires great teamwork and collaboration skills to ensure an efficient way of working to maintain a high level of productivity.
What You Will Achieve
In this role, you will:
Lead technical transfer of ADC processes into the North Creek facility and ensure technical responsibilities for new product introduction competed, such as process modeling, materials planning, batch record generation and SOP generation.
Provide technical support and troubleshoot highly complex technical process issues.
Oversight of process validation, process monitoring, continuous process validation, and database management in partnership with digital groups.
Generate process and facility-related risk assessments.
Provide technical expertise to lead and close investigations, non-conformances, and corrective actions.
Evaluate new and PAT enabling technology for introduction.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience
In-depth knowledge of equipment, operations, and engineering principles related to antibody drug conjugation production
Effective written and verbal communication skills
Strong interpersonal skills and the ability to work collaboratively in a team environment across various business functions
Experience in project management and leading complex projects
Ability to develop and manage plans to achieve objectives
Bonus Points If You Have (Preferred Requirements)
Strong knowledge of GMP manufacture of antibody drug conjugate (ADC) and monoclonal antibody (mAb) purification production processes and associated at-scale equipment and unit operations.
Knowledge of cytotoxic drug-linker handling and solubilization.
Identify process and technology gaps and issues; develop solutions and implementation plans.
Knowledge of cGMPs and regulatory requirements including 21 CFR Parts 210 and 211, and ICH Q7
Experience deploying single-use technologies for manufacturing processes.
Intermediate level understanding of process automation (Wonderware and DeltaV) used for bioprocessing controls systems.
Strong leadership and team management skills
Ability to influence and drive alignment across stakeholders
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
PHYSICAL/MENTAL REQUIREMENTS
Lifting, standing, gowning in cleanroom.
Requires good math skills, basic lab chemistry calculations, working with MS Excel.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require travel from time to time
Work Location Assignment: Hybrid
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. This position requires permanent work authorization in the United States.
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