Associate Director, Engineering - Sterile Production Lead
MSD Malaysia, Rahway, NJ, United States
* Build and lead the Operations organization from inception, including recruiting, staffing plans, role design, onboarding, and capability development.* Partner with engineering, validation, and quality to align operational requirements with C&Q activities; ensure equipment and facilities are released for GMP use and ready for clinical campaigns.* Establish and maintain GMP-compliant operating procedures, standard work, and training programs for aseptic manufacturing, materials management, and facility operations.* Serve as the system owner from the business unit for the process equipment within the filling, formulation, and sterile supply suites.
Emphasis will be placed on the filling line, filling isolator, and lyophilizer.* Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and production control, and readiness drills.* Lead daily operations post-authorization, including production execution, scheduling, material flow, inventory controls, and collaboration with partner groups for tech transfers.* Implement an operational excellence system: tiered daily management, visual performance boards, KPI tracking (safety, quality, delivery, cost, people), deviation reduction, and continuous improvement.* Ensure robust compliance with cGMP, aseptic processing standards, data integrity, and regulatory expectations for clinical manufacturing.* Drive cross-functional coordination with Quality, Technical Operations, EHS, Supply Chain, and Program Management to deliver on clinical timelines and batch release commitments.* Manage capacity planning, scenario modeling, and resource allocation to meet clinical demand and portfolio priorities.* Establish a culture of safety, empowerment, and accountability; lead with clarity, transparency, and a focus on patient impact.* Facility transitions from C&Q to cGMP operations on schedule, with flawless execution of containment verification, media fills and audit readiness activities.* A fully staffed and trained operations team performs with high reliability, compliance, and morale.* Standard work and SOPs are deployed and adhered to; deviations and interventions trend downward quarter-over-quarter.* Clinical batches are delivered on time, at an acceptable yield, with robust quality outcomes.* Continuous improvement pipeline is active and measurable, driving gains in throughput, cycle time, and cost without compromising quality or safety.* Provide manufacturing and operational expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection.* Ability to solve complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Bringing in appropriate stakeholders when required.* Conduct all work activities with strict adherence to the safety and compliance culture on site.* Support the authoring of electronic batch records, sampling plans, and standard operating procedures.* Bachelor’s degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience.* Master’s degree with 6 years of relevant experience, or a* PhD degree with 4 years of relevant experience.* Proven leadership experience in aseptic drug product manufacturing operations within GMP-regulated environments; clinical or early-stage operations experience strongly preferred.* In-depth technical and operational knowledge of aseptic filling lines, isolators, and lyophilizers.* Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent.* In-depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements.* Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI-driven leadership.* Effective cross-functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans.* Hands-on experience with C&Q, facility start-up, media fills, environmental monitoring programs, and readiness for aseptic operations.* Experience applying consultative skills: ability to influence decision making, ability to interact with all levels of the business (senior leaders to shop floor working teams).* Project management skills (demonstrated experience in managing large project teams).* Ability to Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr
Emphasis will be placed on the filling line, filling isolator, and lyophilizer.* Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and production control, and readiness drills.* Lead daily operations post-authorization, including production execution, scheduling, material flow, inventory controls, and collaboration with partner groups for tech transfers.* Implement an operational excellence system: tiered daily management, visual performance boards, KPI tracking (safety, quality, delivery, cost, people), deviation reduction, and continuous improvement.* Ensure robust compliance with cGMP, aseptic processing standards, data integrity, and regulatory expectations for clinical manufacturing.* Drive cross-functional coordination with Quality, Technical Operations, EHS, Supply Chain, and Program Management to deliver on clinical timelines and batch release commitments.* Manage capacity planning, scenario modeling, and resource allocation to meet clinical demand and portfolio priorities.* Establish a culture of safety, empowerment, and accountability; lead with clarity, transparency, and a focus on patient impact.* Facility transitions from C&Q to cGMP operations on schedule, with flawless execution of containment verification, media fills and audit readiness activities.* A fully staffed and trained operations team performs with high reliability, compliance, and morale.* Standard work and SOPs are deployed and adhered to; deviations and interventions trend downward quarter-over-quarter.* Clinical batches are delivered on time, at an acceptable yield, with robust quality outcomes.* Continuous improvement pipeline is active and measurable, driving gains in throughput, cycle time, and cost without compromising quality or safety.* Provide manufacturing and operational expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection.* Ability to solve complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Bringing in appropriate stakeholders when required.* Conduct all work activities with strict adherence to the safety and compliance culture on site.* Support the authoring of electronic batch records, sampling plans, and standard operating procedures.* Bachelor’s degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience.* Master’s degree with 6 years of relevant experience, or a* PhD degree with 4 years of relevant experience.* Proven leadership experience in aseptic drug product manufacturing operations within GMP-regulated environments; clinical or early-stage operations experience strongly preferred.* In-depth technical and operational knowledge of aseptic filling lines, isolators, and lyophilizers.* Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent.* In-depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements.* Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI-driven leadership.* Effective cross-functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans.* Hands-on experience with C&Q, facility start-up, media fills, environmental monitoring programs, and readiness for aseptic operations.* Experience applying consultative skills: ability to influence decision making, ability to interact with all levels of the business (senior leaders to shop floor working teams).* Project management skills (demonstrated experience in managing large project teams).* Ability to Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr