Associate Director, Engineering
MSD Switzerland
Switzerland-LU-Luzern
vor 7 Tg.

Description

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 Global Technical Operations External Manufacturing Sterile Organization is seeking a highly motivated individual to fill an open position to support sterile drug product manufacture at contract manufacturing sites in Europe.

This position is located in Lucerne, Switzerland. The position is an exciting opportunity to work with key strategic external manufacturing partners, lead a technical team of direct reports, and work on high visibility network initiatives with direct access to senior management.

The incumbent will be responsible for driving change in sterile manufacturing, managing risk platforms, and participating on global center of excellence technical teams.

The position has upward growth potential and the opportunity to manage many different sterile products and areas. The department is growing in the coming years and we are seeking top talent to fill leadership positions.

The incumbent will be responsible for the management of the technical interface between MSD and key strategic external manufacturing partners in the sterile small and large molecule, Formulation, Filling and Packaging.

This individual will also be responsible for management of a technical team of direct reports. This individual will be expected to provide leadership and technical solutions to complex technical problems and projects as well as coach junior staff.

This individual must have strong influencing skills and the ability to excel working on cross-functional, cross-company, global teams.

This individual will be responsible for leading and executing technical transfers of a manufacturing process to support Supply from Commercialization to an external partner and other scenarios.

Responsibilities will also 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.

Main responsibilities include but are not limited to :

  • Manages technical issues relating to the global external manufacturing of commercial Drug Product.
  • Provide technical leadership within Technical Operations, Sterile group for the management of sterile drug product.
  • Driving change both internal and external ensuring state of the art technology and processes are implemented and maintained.
  • Lead to resolve technical issues relating to a product line or major technical projects within Technical Operation.
  • Lead a small group of Technical Operations staff to manage technical programs and contract manufacturing organizations.
  • Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
  • Lead and act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers.
  • Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections.
  • Lead critical technical projects relating to the manufacturing of commercial sterile drug product.
  • Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPA and change controls.
  • Coordinates and manages risk assessments and develops solutions to complex issues that require a high degree of ingenuity, creativity and innovation.
  • Requires understanding and application of principles, concepts, practices and standards that govern the manufacturing of sterile products.

    Qualifications

    Education Minimum Requirement :

  • BS in Chemical Engineering, Chemistry, Biotechnology, or other Engineering / Science related Disciplines.
  • Required Experience and Skills :

  • Ability to work effectively across boundaries to build strong collaborative relation with other internal Global Technical Operations, Sterile, External Services partner groups, Small and Large Molecule Sites and external partners.
  • At least Seven (7) or more years of manufacturing experience in the areas of process start up, routine manufacturing and / or technical transfer or have demonstrated experience in these areas, including Three (3) or more years of experience in sterile / aseptic processing or formulation and filling.
  • Strong professional and interpersonal communication skills are also required.
  • Must be able to multi-task and work within tight deadlines.
  • Flexibility and the ability to work independently as well as excellent organizational skills.
  • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
  • Strong analytical problem solving skills, root cause analysis and risk assessment / mitigation.
  • Proven team building skills.
  • Strong technical and leadership skills, strong business acumen, and strong interpersonal and communication skills.
  • Excellent command of English (both written and oral).
  • This role includes approximately 25% travel to within Europe and the US.
  • Preferred Experience and Skills :

  • Experience managing direct reports.
  • Lean Manufacturing / Six Sigma Experience.
  • Project management experience.
  • Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
  • 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. MSD is not accepting unsolicited assistance from search firms for this employment opportunity.

    Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.

    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

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