Merck
Associate Director, Engineering (API Drug Substance)
Merck - Rahway, New Jersey, United States, 07065
Work at Merck
Overview
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Overview
Technical Lead
As a Technical Lead, you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in managing the technical interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing process support, resolving production issues, evaluating process change requests, and proactively managing process and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative efforts. Key responsibilities include: Operate independently on priorities established with assigned External Partners. Foster proactive partnerships with External Partners to meet business goals, identify and mitigate risks, and continuously enhance performance. Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence. Serve as the primary technical contact for assigned External Partners while coordinating with impacted company sites and External Partners. Collaborate with internal teams to ensure seamless product supply with an end-to-end mindset. Initiate and drive change controls to completion. Provide rapid support to External Partners to resolve manufacturing challenges and minimize supply disruptions. Collaborate with Research Laboratories groups during New Product Introductions/Technical Transfers and new technology. Offer on-site support at External Partners as required, proactively identifying risks and supporting all phases of execution. Conduct technical due diligence assessments and provide expert consultation on chemical manufacturing matters. Review process change requests and deviation reports while ensuring regulatory compliance. Education and minimum requirements: Bachelor's degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing or development, in the areas of process start up, technology introduction, manufacturing and/or technical transfer. A minimum of 7 years of experience in manufacturing, specifically in API process production, development, optimization, and technical transfer. Skills requirements: Exceptional organizational skills and the ability to work independently. Proven leadership attributes including a global mindset, an end-to-end supply chain perspective, and strong collaborative abilities across functions and geographies. Demonstrated capacity to solve complex technical challenges, lead project teams, and influence stakeholders effectively. A solid understanding of small molecule pharmaceutical manufacturing processes. Fluency in English is essential. Willing to travel up to 50% of the time. Salary range: $139,600.00 - $219,700.00 The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
As a Technical Lead, you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in managing the technical interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing process support, resolving production issues, evaluating process change requests, and proactively managing process and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative efforts. Key responsibilities include: Operate independently on priorities established with assigned External Partners. Foster proactive partnerships with External Partners to meet business goals, identify and mitigate risks, and continuously enhance performance. Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence. Serve as the primary technical contact for assigned External Partners while coordinating with impacted company sites and External Partners. Collaborate with internal teams to ensure seamless product supply with an end-to-end mindset. Initiate and drive change controls to completion. Provide rapid support to External Partners to resolve manufacturing challenges and minimize supply disruptions. Collaborate with Research Laboratories groups during New Product Introductions/Technical Transfers and new technology. Offer on-site support at External Partners as required, proactively identifying risks and supporting all phases of execution. Conduct technical due diligence assessments and provide expert consultation on chemical manufacturing matters. Review process change requests and deviation reports while ensuring regulatory compliance. Education and minimum requirements: Bachelor's degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing or development, in the areas of process start up, technology introduction, manufacturing and/or technical transfer. A minimum of 7 years of experience in manufacturing, specifically in API process production, development, optimization, and technical transfer. Skills requirements: Exceptional organizational skills and the ability to work independently. Proven leadership attributes including a global mindset, an end-to-end supply chain perspective, and strong collaborative abilities across functions and geographies. Demonstrated capacity to solve complex technical challenges, lead project teams, and influence stakeholders effectively. A solid understanding of small molecule pharmaceutical manufacturing processes. Fluency in English is essential. Willing to travel up to 50% of the time. Salary range: $139,600.00 - $219,700.00 The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.