Job Detail

JOB DESCRIPTION

Job Description

The Organon S&T PTO External Manufacturing Sterile Tech-Ops 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 -part, 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 incumbent will be responsible for the management of the technical interface between Organon and key strategic external manufacturing partners in the sterile small and large molecule, Formulation, Filling and Packaging. 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. The incumbent must have strong technical and leadership skills, strong business acumen, and strong interpersonal and communication skills.

Key Responsibilities:

• 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.


• 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, continued process verification, 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.

Education:       

• Bachelor of Science 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


• Longtime experience of manufacturing experience in the areas of process start up, routine manufacturing and/or technical transfer or have demonstrated experience in these areas, including several years of experience in sterile/ aseptic processing or formulation and filling


• Strong professional and interpersonal communication skills


• 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


• Willing and flexible for traveling within Europe approx. 25%


• Excellent command of English (both written and oral)

Preferred Experience and Skills:

• Lean Manufacturing / Six Sigma Experience


• Project management experience


• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections 


• Authentic, Empathetic, Curious and Courageous

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Specified

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

No

Number of Openings:

1

Requisition ID:OR000016C