Sr. Manager, Technical Services

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We are a 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 who 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, a can‑do attitude, thrive in a high‑paced environment, and embrace 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.

• Lead technical transfer of ADC processes into the North Creek facility and ensure technical responsibilities for newстве product introduction, 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.

• 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.
• স্মখ 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.
Qualification:

“Ability to develop and manage plans to achieve objectives.”

• Strong knowledge of GMP manufacture of antibody drug conjugate (ADC) and monoclonal antibody (mAb) purification production processes andجا associated at‑scale equipment and unit operations.
• Knowledge of cytotoxic drug‑linker handling and solubilization.
• 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 Delta
  
  V) used for bioprocessing control 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…