Drug Product Operations Program Manager
2 weeks ago
We are seeking an Operations Program manager to drive the cross-functional execution of operations preparedness with a strong focus on resource & components planning, training and onboarding planning, and procedural systems.
This role is also focused on developing and implementing robust processes, systems, and readiness activities aligned with best practices from the company network and industry benchmarks, and ensuring "right-first time", "on-time" and an efficient startup readiness.
Responsibilities Lead the operational readiness program plan, incorporating people, process, and procedural readiness from facility design to production start-up.
Collaborate with Operational readiness lead and convert the roadmap to a clear project plan with resources and milestones identified.
Drive the definition of roles and organizational design for the new facility, ensuring alignment with operational needs and startup milestones.
Develop and maintain an integrated readiness timeline, capturing critical path activities including onboarding, training, batch record development, and procedural readiness.
Lead the design, development, and deployment of onboarding and training systems to support a high-performing manufacturing team.
Oversee the development of procedures, batch record training materials, and training documentation to support GMP operations.
Track and report readiness progress, risks, and mitigation strategies to senior leadership and site governance forums.
Support resource planning and organizational onboarding activities to ensure timely staffing and readiness of operations teams.
The role has potential to evolve into leading and managing end-to-end training plan, partnering with site training functions and functional leaders to ensure execution of both self-learning and trainer-led programs.
Facilitate cross-functional collaboration with internal and external stakeholders to embed industry best practices into startup plans and training systems.
Qualifications Bachelors degree in Engineering, Science, Manufacturing, or a related field.
3-5 years of experience in biopharma or pharmaceutical operations, including aseptic drug product manufacturing.
5+ years of experience in program or project management, preferably in a startup or facility expansion context.
Proven success in leading cross-functional teams and managing complex, matrixed initiatives.
Preferred Qualifications: PMP or equivalent project management certification.
Experience supporting startup of sterile syringe fill-finish facilities.
Familiarity with the companys network or similar global biopharma operations.
Knowledge of training systems (e.g., Learning Management Systems) and structured onboarding methodologies.
Demonstrated ability to drive cultural and operational readiness through scalable systems and processes.
Strong leader with exceptional organizational, planning, and stakeholder management skills.
Collaborative and influential across multiple functions.
Passionate about building operational excellence through people and process.
Energized by startup environments with a hands-on, proactive mindset.
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