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ExM Tech Ops – Drug Substance Lead (m/f/d)

Boxmeer, Netherlands; Luzern, Switzerland

Job Description

Our Large Molecules External Manufacturing (LM ExM) network spans US, EU and AP, and includes the drug substance and drug product manufacture of vaccines and biologics products.  The LM External Manufacturing Technical Operations organization provides technical oversight to established commercial products and new product introductions within this complex network.

We are currently seeking a Sr. Specialist level ExM Tech Ops – Drug Substance Lead to fill an open position to support drug substance manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule line of business at our company.

Our Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

Responsibilities include:

  • Work with external partners to achieve business goals and to establish a common culture that benefits both our company, external partners, and patients

  • Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers

  • Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events

  • Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings

  • Develops solutions to complex technical 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

  • Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities

  • Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners

  • Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory

  • Responsible for participation in creating, sharing, and adopting best practices and business process strategies

Education Minimum Requirement:

  • Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field

Required Experience and Skills:

  • Minimum of 7 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology or Engineering

  • Ability to work independently as well as excellent organizational skills

  • Strong professional and interpersonal communication skills

  • Must be able to multi-task and work within tight deadlines

  • Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation

  • Proven team building skills

  • Excellent command of English (both written and oral)

  • Travel will be a requirement of this position at approximately 25%

Preferred Experience and Skills:

  • Experience in biologics manufacturing

  • Experience with the manufacturing of ADCs

  • Project management experience

  • Experience in deviation management and/or change control and/or equipment support, and/or project management

  • Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections

THE COMPANY

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in 2021 in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

Our Tribschenstrasse office, located in the city of Luzern has a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID: R287285

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