MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Chemical Technical Operations (CTO) organization is seeking a highly motivated individual to fill a new position to support the manufacture of sterile and non-sterile drug substances and intermediates. The Associate Director, CTO, External Manufacturing Technology, Sterile API position is a technical leadership role, reporting to the Director, Chemical Technical Operations, External Manufacturing Technology, Sterile API . The technical lead will provide process support to External Partners (EP) in MSD External Manufacturing (ExM) Focus Factory to resolve production issues, evaluate and manage process change requests, proactively assess and manage process/technical risks, and provide guidance on process improvement and capacity optimization. This individual will be expected to provide leadership and technical solutions to complex technical problems and projects, have strong influencing skills and the ability to excel working on cross-functional, cross-company, global teams.
Responsibilities include:
Functions independently with minimal oversight
Collaborates with Focus Factory team members (eg. Operations and Quality) and others to facilitate supply of products from EP’s with an End-to-End mindset.
Coordinates with impacted (downstream and upstream) MSD sites and EP’s.
Maintains strong technical connectivity with the MSD Sterile Network and represents the small molecule API Platform technical team as the point of contact to the Sterile Network.
Builds technical capability in the Focused Factory team in aseptic processing and sterile operrations.
Initiate and drive change controls to completion
Provide technical transfers and validation support as well as development of plans to meet capacity needs.
Provides rapid responsive support to EPs to resolve manufacturing issues and minimize supply disruptions.
Proactive partnership with EP's to achieve business goals, mitigate risks and continuously improve performance so as to establish a common culture that benefits both MSD and EP
Demonstrates consistently a strong compliance and EHS mindset in driving excellence in supply performance in the Focused Factory, ensuring inspection readiness at all times.
Partners effectively and leads the interface with our research division groups (Process Chemistry, Chemical Engineering R&D, Analytical R&D), as well as other MSD
Science and Technology groups (Supply Analytical Sciences, Center for Mathematical Sciences, Material Sciences etc.) on aligned priorities.
Executes technical due diligence assessments at potential EP’s.
Provides expert consultation and review of small molecule manufacturing technical matters.
Provides a 'calibrated' technical review of EP process change requests and deviation reports.
Understands the true regulatory requirements and partners with Operations, Quality, Regulatory and the EP in applying efficient ways to meet these requirements.
Qualifications
BSc/MS/Ph.D in in chemical/biochemical engineering, pharmaceutical science or chemistry or related fields
Minimum of 7 years of post-qualification experience, including four (4) or more years of experience with sterile/aseptic processing. Manufacturing experience in the areas of Sterile and API process production, with demonstrated experience in process start up, process optimization, and technical transfer.
Experience in biological manufacturing including fermentation, chromatography, and downstream purification is a plus.
Experience in leading technical teams in the areas of process development / commercialization / tech transfer / supply of API products
Flexibility and the ability to work independently, with excellent organizational skills.
Strong Leadership Behavior attributes including a global mindset, an end to end supply chain view, ability to collaborate across functions and geographies and multi-task effectively, strong interpersonal and communication skills, ability to establish and maintain strong working relationships with technical, quality and operations leaders in the internal and external network.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.
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