Job Description

Job Description

Our Engineers support 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.

General Summary:

The Large Molecule (LM) External Manufacturing Technical Processes and Systems Lead for vaccines and/or biologics will be based in the USA and report to the Executive Director, Large Molecule ExM Technical Leader. The right candidate will be someone who can navigate a complex network of drug substance and/or drug product, across vaccines and/or biologics modalities and tech support models. In addition, the candidate needs to partner with technical functions to evolve the technology support model to ExM operations in a way that is most efficient and effective for the organization. The Technical Leader will be responsible to lead the transformation of the Large Molecule External Manufacturing Tech model for CMOs: from defining and implementing standard work, driving operational excellence in the technical space, influencing multiple technical and operations stakeholders, and transforming our Ways of Working. This role is critical to the organizations ability to drive efficiencies and effectiveness, increase predictive prioritization in alignment with efficient resource model, and utilizing digital transformation within the technical space in External Manufacturing. As part of the LM ExM Technical leadership team, this individual will have key accountability for owning standard work and transformational initiatives that include prospective risk-driven technical decision making.

Position Profile:

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

The Technical Lead is accountable for ensuring External Manufacturing can assure supply of quality, cost effective externally produced products (Phase III through maturity/decline) and establishing / maintaining mutually beneficial technical relationships with our internal technical partners and CMO leadership, supporting the vaccine and biologics businesses. The Leader is tasked with partnering with Global Technical Operations (vaccines and biologics) and Manufacturing Systems Design and Commercialization leadership supporting Exteranl Manufacturing Sites to determine the most effective way to leverage technical teams to successfully expand the External Network of partners and products, while sustaining support to the growing portfolio of products. The leader will also have the critical role of supporting, defining and standardizing enhanced technical oversight models for our most critical partnerships and assets, and execution across SMEs and aligned technical groups. This individual must be able to lead through uncertainty and leverage the broader Large Molecule network to ensure the right individuals are engaged with clear roles and responsibilities defined. The Leader is expected to collaboratively design a fit for purpose model to support the Large Molecule network, recognizing the high degree of complexity associated with our externally facing portfolio. This individual will also partner with the broader LM technical network to ensure clear and consistent technical communications on ExM products across the network.

The Leader will support the ExM business via CMO evaluations, contract negotiations, CMO Governance meeting (as appropriate), and management of a Balanced Scorecard. This individual works in collaboration with the LM ExM Technical Platform and Operations Leads, Modality specific technology leads, Quality and Procurement.

The primary focus of the Leader is to provide technical and project leadership to Large Molecule External Manufacturing business for:

* Providing a single voice for Cross Operating Unit (OpU) Technical Initiatives on ExM leadership team

* Define and implement standard work on tech transfers and commercial support

* Own technical transformation initiatives within the Biologics and Vaccines CMO space

* Ensure key Tech Transfers are positioned for successful business outcomes

* Portfolio based technical oversight, management and planning support for all LM ExM Tech Ops projects

* Ensure targeted communications and alignment across technical functions

* Influence peer technical functions to adopt and drive new Ways of Working at the CMO interface

* Refine and own technical resource model for new programs within the portfolio

* Accountable for supporting the ExM Operations lead in assuring risk identification/mitigation

Candidate Profile:

Education Minimum Requirements:

* BS degree in Engineering or Science is required. An advanced degree in Engineering, Science, or Business is preferred.

Required Experience and Skills:

* Minimum of 15 years post-bachelors degree expertise in Drug Substance and/or Drug Product, in biologics and/or vaccines manufacturing, and/or technical support of operations is required.

* Advanced problem-solving skills and experience leading teams to resolve highly complex business or technical issues is required.

* Excellent leadership, team management, change management, interpersonal, collaboration, and analytical skills, including verbal and written communication, is required.

* Capability in leading and delivering required outcomes in a complex matrix organization is required.

Preferred Experience and Skills:

* Technical and/or Operational expertise in both Large Molecule Drug Substance and Drug Product is preferred.

* Expertise and demonstrated accomplishments leading complex technical transfers is required.

* Experience in leading cross-functional teams in support of manufacturing operations at internal sites or external partners is preferred.

* Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity is preferred.

* Advanced problem-solving skills and experience leading teams to resolve highly complex business or technical issues is required.

* Excellent leadership, team management, change management, interpersonal, collaboration, and analytical skills, including verbal and written communication, is required.

* Capability in leading and delivering required outcomes in a complex matrix organization is required.

* Ability to motivate an organization around a common vision and deliver expected results is preferred.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

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Who we are

We are known as Our Company., Inc., Kenilworth, New Jersey, USA in the United States and Canada and Our Company everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R94364