Global Technical Operations at MSD is seeking a degree-level educated individual with good technical knowledge of sterile formulation and filling unit operations to join our Biological-Sterile (GTO Bio-Sterile) External Manufacturing organization, supporting sterile drug product manufacture at contract manufacturing sites. Our team strives to not only provide technical excellence to our work but to be strong partners, collaborators and leaders within the small and large molecule lines of business at MSD as well as externally to identify and incorporate new and innovative approaches.
In this highly visible role, you will execute technical transfers to and from External Partners (EP's) and ensure project timelines are met. Your responsibilities will include leading the technical interface with the external partners in the area of process support to aid in the resolution of production issues that could impact Supply and also to provide guidance on process optimization.
Work location is Lucerne, Switzerland; business travel of up to 25% will be required depending on site needs or vendor support.
Main activities include but will not be limited to: • Execute technical transfers, provide on-going support to External Partners to resolve manufacturing issues, and develop plans to meet capacity needs • Execute technical due diligence assessments at External Partners • Independently provide coordination, communication, and oversight of assigned External Partner technical issues • Collaborate with Purchasing, Relationship Manager, Quality, Regulatory and others to evaluate External Partners for inclusion in the MSD Network • In concert with Commercialization, Quality, and Regulatory, ensure that External Partners are inspection-ready for all new product introductions and transfers • Develop and execute validation strategies for new and existing products • Provide a single point of technical contact to assigned EP's, impacted Manufacturing Division sites and Commercialization • Provide expert consultation and review of sterile processing technical matters • Provide a 'calibrated' technical review of EP process change requests, atypicals, and Master Batch Record changes • Understand the true regulatory requirements and partner with Operations, Quality, and the EP to develop more efficient ways to meet these requirements • Based on calibrated oversight model, minimize duplication of efforts between EP and MSD systems • Partner with External Partners to achieve business goals and to establish a common culture that benefits both MSD and External Partners
Qualifications: Required skills and Experience: • Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science or Chemistry/Biology • At least 5 years of manufacturing experience in the areas of sterile/aseptic process start-up and technical transfer or demonstrated shop floor experience in sterile/aseptic manufacturing • Familiarity with project management methodology • Business travel will be a requirement of this position at approximately 25% • Proven ability to multi-task and work within tight deadlines • Logical thinking, demonstrated flexibility and the ability to work independently • Excellent organizational skills and ability to function within a highly matrixed environment • Strong professional and interpersonal communication skills • Communication skills, demonstrated ability to interpret and communicate issues to senior management • Fluency in English, both oral and written Preferred skills and experience: • Project Management and Basic Statistical Analysis experience • Proven analytical and technical problem-solving abilities • Experience performing root cause analysis and utilizing six sigma tools • Demonstrated ability to drive change, influence decision making and interact with all levels of the business • Solid business acumen • Proven team building skills
MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.
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