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 highly motivated EU Regional lead, reporting to the Vaccine ExM Technical Operations Lead, who will be accountable for managing the regional team of focus factories, and providing technical guidance and oversight to our external network of CMO partnerships across biologics and vaccines (Drug Substance and Drug Product) for both commercial and pipeline products.

The qualified candidate will bring a passion for people development, a drive technical depth, and will maintain and expand collaborative partnerships with internal and external partners to ensure that technical support flowing into established Virtual Focus Factories is aligned with the needs and expectations of each external site and aligns with the overall strategy of creating an efficient, robust, compliant, cost-effective supply for our portfolio of life saving products.

Primary Responsibilities

In this role, the qualified candidate will drive technical rigor and structured support for technology transfer of pipeline and in line products to new and established CMO partnerships, as well as provide in depth technical support to and monitoring of establish products across our network of CMO partnerships. They will bring practical experience and expertise across vaccines and biologics to support right-first-time technology transfer, efficient and effective resolution of complex investigations, sustained robust process performance, and continuous improvement.

In addition to providing technical leadership, the qualified candidate will have a demonstrated ability to attract, coach and develop talent and to build an inclusive culture that leverages diverse talent to fully enable a high performing team and organization. They will foster a highly collaborative and inclusive environment within the team and across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a boundary less organizational mindset (right people, place, time).

Education Requirements:

· A Bachelor’s degree in Engineering or Science is required. An advanced degree in Engineering, Science, or Business is preferred

· Bachelor of Science (BS) Degree in life sciences or equivalent with twelve (12) years of relevant experience

· Master of Science (MS) Degree in life sciences or equivalent with ten (10) years of relevant experience

· PhD in life sciences or equivalent with eight (8) years of relevant experience

Skill Requirements:

· Technical Expertise in Vaccines or Biologics Drug Substance Technical Operations, with a demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results.

· Direct technical leadership experience in leading a technical Transfer of a large molecule Drug Substance program.

· Organizational management and experience building lean and agile teams

· Understanding of cost levers driving productivity and process improvements

· Ability to solve complex problems and create solutions that drive value

· Ability to drive technical excellence by modeling and teaching scientific problem-solving approaches to team and peers, and leveraging network capabilities and expertise

· Engages partners and performs work with a service mindset

· Build diverse talent with the capabilities necessary for future success

· Support and sponsor teams, and remove barriers as needed

· Communicates a sense of urgency, high performance bars and changes to deliverables in a timely manner with workgroup and stakeholders

· Balances technical rigor and business outcomes effectively in solving problems

Preferred Experience and Skills

Desired:

· Green belt or demonstrated Lean Six Sigma track record

· Experience in complex international environment with matrix organization structures is preferred

· Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred

· Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements

Travel Requirements:

· 25-50% for partner assignments outside of primary location. Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments

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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

Job Posting End Date:

03/31/2025

*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.