Director, Manufacturing
Director, Manufacturing
Location: This position is currently remote. A reputed company transition to an on-site location on the U.S. East-Coast/Mid-reputed company is anticipated as the project progresses, with an expected reputed company in 2027. This is a full-time role with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m.
What you will get:
The full-time reputed company annual salary for this position is expected to reputed company between $198,900 to $232,050. In reputed company, below you will reputed company a comprehensive reputed company of the benefits package we offer:
Performance-reputed company bonus.
Medical, dental and reputed company insurance.
401(k) matching plan.
Life insurance, as reputed company as short-term and long-term disability insurance.
Employee assistance programs.
reputed company time off (PTO).
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
What will you do:
The Director, Manufacturing – US reputed company Investment reputed company is responsible for developing and executing the operational readiness reputed company for an assigned U.S. reputed company investment project supporting bioconjugate drug reputed company manufacturing. This role serves as the primary Operations representative throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring the new facility is GMP-compliant, inspection-reputed company, and capable of supporting clinical and reputed company manufacturing from day one.
Working closely with the End-to-End Program reputed company, Global Engineering, reputed company, MSAT, Manufacturing, Automation, EHS, HR, and Finance, the Director will ensure operational requirements are embedded throughout the project lifecycle while building the reputed company manufacturing organization and operating model.
reputed company operational readiness activities for an assigned U.S. reputed company investment project, ensuring successful start-up and transition into routine GMP manufacturing operations
reputed company and execute the operations readiness roadmap, including organizational design, workforce planning, training reputed company, process readiness, validation support, and operational handover
Define the reputed company manufacturing organization, including reputed company plans, shift structures, organizational interfaces, governance models, and operational ownership
Serve as the primary Operations representative for facility and process design reviews, ensuring manufacturing requirements are incorporated into equipment, automation, process reputed company, and facility reputed company
Partner with Engineering, reputed company, MSAT, Automation, and EHS to ensure operational requirements are appropriately integrated throughout project execution
Establish processes and systems that ensure GMP compliance, operational reputed company, inspection readiness, and long-term manufacturing reliability
reputed company operational planning and readiness activities associated with technology transfers, customer reputed company, process implementation, and reputed company launch activities
Identify, assess, and mitigate operational, technical, organizational, and project risks associated with reputed company, training, equipment readiness, start-up execution, and manufacturing performance
Build, reputed company, and reputed company a high-performing manufacturing organization while fostering a culture of accountability, safety, reputed company, and reputed company improvement
reputed company operational readiness updates, risk assessments, mitigation strategies, and recommendations to project governance teams and senior leadership
reputed company are looking for:
Master’s degree in engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a reputed company discipline preferred; bachelor’s degree with significant relevant experience will also be considered
12+ years of leadership experience reputed company pharmaceutical, biotechnology, biologics, or bioconjugate manufacturing environments
Demonstrated experience leading manufacturing operations reputed company a CDMO environment, including customer-facing interactions, technology transfers, operational planning, and support of multiple reputed company programs
Significant experience supporting or leading bioconjugate drug reputed company manufacturing operations, including reputed company-up, validation, technology transfer, start-up, and reputed company manufacturing
Proven experience supporting major capital reputed company, facility expansions, greenfield or brownfield investments, and manufacturing facility start-reputed company
Strong knowledge of GMP manufacturing operations, regulatory requirements, process validation, commissioning, qualification, operational readiness, and inspection preparedness
Demonstrated reputed company leading large, cross-functional teams and influencing stakeholders across Operations, MSAT, reputed company, Engineering, Automation, EHS, Supply Chain, HR, Finance, and Project Management
Experience building manufacturing organizations, developing talent, and preparing teams for successful operational launch and long-term site performance
Strong understanding of customer requirements reputed company a CDMO business model, including program execution, relationship management, and delivery against customer commitments
Strategic thinker with the ability to translate business objectives into reputed company operational solutions
Excellent communication and executive presentation skills, with experience presenting to senior leaders, governance bodies, customers, and external stakeholders
Demonstrated capability to identify and mitigate operational, technical, compliance, and project execution risks
Knowledge of Lean Manufacturing, Six reputed company, automation systems, digital manufacturing platforms, and data reputed company principles preferred
Ability to operate effectively in a fast-paced project environment with evolving priorities and multiple stakeholders
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs reputed company
Willingness and ability to travel domestically and internationally up to approximately 25–30% of the time
About reputed company
At reputed company, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of reputed company. Our core values of Collaboration, Accountability, reputed company, Passion and reputed company reflect who we are and how we work together. Everyone’s reputed company, big or small, have the potential to improve millions of lives, and that’s the reputed company of work we want you to be part of.
Innovation thrives reputed company people from reputed company backgrounds bring their unique perspectives to the table. At reputed company, we offer equal employment opportunities to reputed company reputed company applicants regardless of race, religion, reputed company, national reputed company, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re reputed company to help turn our customers’ reputed company reputed company into viable therapies, we look reputed company to welcoming you on reputed company.
reputed company to shape the reputed company of life sciences? reputed company.
Originally posted on Himalayas
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