Sr. Manager, Technical Services

Role Summary

Senior Manager, Technical Services at Pfizer’s North Creek Manufacturing Facility, focused on transferring Antibody Drug Conjugate (ADC) production processes to and from the site and providing technical and validation support to GMP manufacturing. Leads troubleshooting of technically complex issues, evaluates new technologies, and drives continuous improvement in a fast-paced, collaborative environment. Requires conjugation and downstream production experience in GMP manufacturing and strong teamwork skills.

Responsibilities

• Lead technical transfer of ADC processes into the North Creek facility and ensure technical responsibilities for new product introduction are completed, including process modeling, materials planning, batch record generation, and SOP generation.
• Provide technical support and troubleshoot highly complex technical process issues.
• Oversee 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.

Qualifications

• Required: Bachelor's degree with at least 6 years of experience; or a Master’s with 5 years; or a PhD with 1+ years of experience.
• Required: In-depth knowledge of equipment, operations, and engineering principles related to antibody drug conjugation production.
• Required: Effective written and verbal communication skills.
• Required: Strong interpersonal skills and ability to work collaboratively across various business functions.
• Required: Experience in project management and leading complex projects.
• Required: Ability to develop and manage plans to achieve objectives.
• Preferred: Strong knowledge of GMP manufacture of ADC and mAb purification, at-scale equipment and unit operations.
• Preferred: Knowledge of cytotoxic drug-linker handling and solubilization.
• Preferred: Identify process and technology gaps and develop solutions and implementation plans.
• Preferred: Knowledge of cGMPs and regulatory requirements including 21 CFR Parts 210 and 211, and ICH Q7.
• Preferred: Experience deploying single-use technologies for manufacturing processes.
• Preferred: Intermediate understanding of process automation (Wonderware and DeltaV) used for bioprocessing controls systems.
• Preferred: Strong leadership and team management skills.
• Preferred: Ability to influence and drive alignment across stakeholders.
• Preferred: Experience using AI tools to support problem solving and productivity, with an interest in responsible AI practices.

Skills

• Technical transfer and process modeling
• GMP manufacturing and quality systems
• Process validation and risk assessment
• Problem solving and root cause investigation
• Cross-functional collaboration and project leadership
• Automation and digital data integration
• Regulatory knowledge relevant to ADC/mAb operations

Additional Requirements

• Physical: Lifting, standing, gowning in cleanroom; reading and interpreting technical documents; routine math and Excel use.
• Travel: May require travel from time to time.
• Work Location: Hybrid