Job Opportunities in Switzerland

Our Large Molecules External Manufacturing (LM Ex M) 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 highly motivated individual to fill an open Associate Director Technical Operations role, 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.

Primary responsibilities for this position include, but are not limited to, the following:

• Lead and act as the primary interface on technical issues between technical operations and the external partner.
• Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance.
• Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.
• Collaborates with procurement, external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) for inclusion in our company network.
• Executes technical due diligence assessments at external partner(s).
• Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
• Executes identification and assessment of partner risks and develops mitigation plans.
• Executes validation strategies for new and existing products.
• Provides manufacturing process support to external partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
• Supports/coordinates/manages complex investigations, with appropriate interface with other impacted manufacturing sites.
• Provides a technical review of external partner process change requests, deviations, and master batch record changes. Minimizes duplication of efforts between external partner and our systems.
• Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility.
• Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

Education and Minimum Requirements:
Bachelor’s degree in engineering, biological/chemistry sciences or related discipline with a minimum of 10 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer

Required Skills and Experience:

• Minimum of 5 of experience in Drug Substance with experience in leading Drug Substance Technical Transfers and commercial manufacturing
  
• Ability to work effectively across boundaries to build strong collaborative relation with other internal teams, such as; Global Technical Operations, External Services partner groups, and external partners.
  
• Strong professional and interpersonal communication skills are required.
  
• Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
  
• 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 Substance Manufacturing and Validation.
  
• Strong analytical problem-solving skills, root cause analysis and risk assessment/mitigation
  
• Excellent command of English (both written and oral).
  
• Travel will be a requirement of this position at approximately 25%
  
• Preferred Experience and Skills:
  
• People management experience
  
• Experience in Vaccine DS
  
• Lean Manufacturing / Six Sigma Experience
  
• Project management experience
  
• 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 stablished 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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/10/2024

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Requisition ID:R314577