MSAT总监
Director, MSAT
总监,MSAT
地点:此职位目前为远程办公。随着项目推进,预计未来会转为美国东海岸/中西部的现场办公,预计时间在2027年。此职位为全职,工作时间为周一至周五,上午8点至下午5点。
您将获得:
该职位的全年固定薪资预计在205,200美元至239,400美元之间。此外,以下是您将享有的福利包概要:
- 与绩效相关的奖金。
- 医疗、牙科和视力保险。
- 401(k)匹配计划。
- 寿命保险,以及短期和长期残疾保险。
- 员工援助计划。
- 带薪休假(PTO)。
此职位的薪酬将根据候选人的资格、技能、经验和相关知识进行确定。
您将负责:
我们正在寻找一位总监,MSAT,领导一个指定的美国增长投资项目的流程准备策略,支持小分子药物原料的生产。此职位在整个设施设计、建设、调试、确认、验证、启动和运营交接过程中担任主要的MSAT负责人,确保制造流程稳健、符合GMP,并能够支持可靠的临床和商业生产。总监将与工程、制造、质量、自动化、EHS和项目领导紧密合作,确保运营和技术要求贯穿整个设施生命周期。
- 领导指定的美国增长投资项目的MSAT工作流,确保小分子制造运营的成功流程实施和运营准备
- 制定并执行流程稳健性和准备路线图,在设计、建设、调试、确认和启动活动中协调内部和外部利益相关者
- 提供与流程相关的调试、确认、验证准备、启动活动及向商业运营转移的领导
- 负责流程生命周期管理活动,包括流程引入、技术转移、验证策略、流程监控、持续改进和监管支持
- 与工程、制造、质量、自动化和EHS团队合作,确保流程要求被纳入设施、设备和自动化设计决策中
- 推动技术
查看英文原文
Director, MSAT
Location: This position is currently remote. A future transition to an on-site location on the U.S. East-Coast/Mid-West is anticipated as the project progresses, with an expected timeline 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 base annual salary for this position is expected to range between $205,200 to $239,400. In addition, below you will find a comprehensive summary of the benefits package we offer:
- Performance-related bonus.
- Medical, dental and vision insurance.
- 401(k) matching plan.
- Life insurance, as well as short-term and long-term disability insurance.
- Employee assistance programs.
- Paid time off (PTO).
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
What will you do:
We are seeking a Director, MSAT to lead the process readiness strategy for an assigned U.S. growth investment project supporting small molecule drug substance manufacturing. This role serves as the primary MSAT leader throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring manufacturing processes are robust, GMP-compliant, and capable of supporting reliable clinical and commercial production. The Director will work closely with Engineering, Manufacturing, Quality, Automation, EHS, and Project Leadership to ensure operational and technical requirements are embedded throughout the facility lifecycle.
- Lead the MSAT workstream for an assigned U.S. growth investment project, ensuring successful process implementation and operational readiness for small molecule manufacturing operations
- Develop and execute the process robustness and readiness roadmap, coordinating internal and external stakeholders throughout design, construction, commissioning, qualification, and start-up activities
- Provide leadership for process-related commissioning, qualification, validation readiness, start-up activities, and transfer to commercial operations
- Own process lifecycle management activities, including process introduction, technology transfer, validation strategy, process monitoring, continuous improvement, and regulatory support
- Partner with Engineering, Manufacturing, Quality, Automation, and EHS teams to ensure process requirements are incorporated into facility, equipment, and automation design decisions
- Drive technology transfer, process scale-up, and product introduction activities supporting clinical and commercial small molecule manufacturing programs.
- Identify, assess, and mitigate technical, operational, and project-related risks while ensuring long-term process reliability, compliance, and operational excellence
- Build, develop, and lead a high-performing MSAT organization while providing strategic updates, readiness assessments, and recommendations to senior leadership and project governance teams
What we are looking for:
- Master’s degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline preferred; Bachelor's degree with significant relevant experience will also be considered
- 12+ years of experience in pharmaceutical or API manufacturing, including leadership experience within MSAT, Technical Operations, Process Engineering, or Manufacturing Operations
- Demonstrated experience supporting or leading small molecule drug substance manufacturing processes, including process scale-up, technology transfer, process validation, commercial manufacturing support, and lifecycle management and process robustness
- Proven experience supporting major capital investment projects, facility start-ups, manufacturing expansions, or large-scale operational growth initiatives
- Strong knowledge of GMP manufacturing operations, regulatory requirements, commissioning, qualification, validation, process performance monitoring, technology transfer, and inspection readiness within a small molecule manufacturing environment
- Experience leading cross-functional teams and influencing stakeholders across Engineering, Manufacturing, Quality, Automation, Analytical Development, Supply Chain, EHS, Finance, and Project Management organizations
- Experience leading technology transfer, process scale-up, and commercialization within a multi-product API manufacturing or CDMO environment, including cross-site product transfers, is preferred.
- Demonstrated success building and developing high-performing technical teams while driving operational excellence, continuous improvement, and organizational readiness
- Excellent communication, strategic planning, and risk management skills, with experience presenting to executive leadership, governance committees, customers, and external stakeholders
- Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve
- Travel: Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives
About Lonza
At Lonza, 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 tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Originally posted on Himalayas