Executive Director, Vaccines External Development

Job Description

We are seeking an esteemed leader in the external process development and manufacturing of vaccine drug substances (DS) as the Executive Director for External Development, based in West Point, PA. This position will play a critical role in leading and coordinating key activities with strategic partners external to our company for vaccine development and manufacturing, life cycle management, and pandemic readiness, as well as driving operational excellence internally.

Our department Vaccines and Advanced Biotechnologies (VAX) Process R&D in Development Sciences & Clinical Supply (DSCS) is responsible for the development and clinical manufacturing of DS for the vaccine pipeline at our company, spanning from preclinical to commercialization stage. We are part of the Process R&D organization, which enables modality-agnostic DS process development and clinical manufacturing for all of our company's pipeline.

The individual will report directly to the Associate Vice President of VAX Process R&D and will be expected to expertly represent the group on certain capacities, including but not limited to due diligence, regulatory input, and program leadership. The role will also serve as a key mentor for the development of scientific and operational talents from a diverse background and advance our company's commitment to a diverse and inclusive work environment.

Primary Responsibilities

Strategic CMC Liaison with Hilleman Laboratories (an equal-joint venture between our company and British charitable foundation Wellcome Trust, named after the vaccine legend Dr. Maurice R Hilleman).Foster strong partnerships and facilitate collaboration to drive scientific advancements and global access of vaccines and drugs.CMC Lead for the next gen development for commercial vaccines through external collaborations.Lead CMC activities for the selected projects, which includes both clinical and commercial process development, technology transfer, manufacturing, and commercialization.Ensure effective coordination and execution of these activities to meet project timelines and objectives.CMC Liaison for Life Cycle Management (LCM) through external collaborations.Serve as the representative of DSCS for vaccine LCM projects to enable global access of vaccines.Work closely with the Clinical, Marketing, and Commercial Manufacturing team to identify LCM projects for vaccines that require external collaboration and externalization.From ideation to proposal and governance review, collaborate with internal and external stakeholders to drive the successful execution of these projects through external development.Collaborate with internal stakeholders in Discovery, Clinical, Commercial Manufacturing, Regulatory Affairs and Legal to develop a robust plan for pandemic/epidemic preparedness. This includes assessing and addressing potential risks, implementing mitigation strategies, and ensuring that the company is well-prepared to address such challenges from vaccine CMC perspective.Act as the CMC representative for external collaborations with government agencies and NGOs for pandemic/epidemic preparedness. Operational Excellence Lead at VAX PR&D: Leading operational excellence initiatives at the VAX PR&D organization.Align metrics, best practices, and standards across with other GMP pilot plants in PR&D to ensure Right First Time, efficient and compliant operations.

Education

Bachelor's Degree in microbiology, biochemistry, chemical engineering, or a relevant field.

Required Experience And Skills

A minimum of 20 years of leadership and managerial experience in vaccine CMC development, clinical GMP manufacturing, and commercial GMP manufacturing.Strong knowledge and expertise in vaccine development and CMC development, with a track record of leading Product Development teams and CMC development teams.Proven track record in strategic collaborations and international partnership management of vaccine development and GMP manufacturing for both DS and DP.Experience in pandemic/epidemic readiness planning and operation.Demonstrated ability to lead and drive operational excellence initiatives.Excellent communication, leadership, and influencing skills.Based in West Point, PA is required.

Preferred Experience And Skills

Extensive hands-on experience in vaccine process development, clinical and commercial manufacturing, as well as Quality oversight.Solid experience and proficient with major cell substrates (E. coli, yeasts, HEK293, Vero, CHO, etc) and modalities (LVV, viral vectors, RNA, protein subunits, conjugates, etc). Extensive experience in state-of-the-art LVV development is desired.Strong knowledge of global regulatory, quality and manufacturing requirements for vaccines.Working knowledge on Drug Product Intermediates and adjuvant development and manufacturing.Experience in navigating complex governance processes and facilitating decision-making.Passionate for vaccine equity and global access.Resourceful leadership in mentoring and advocating diversity, equity and inclusion for talent development.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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About

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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 another’s thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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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

Domestic

VISA Sponsorship

Yes

Travel Requirements

25%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Requisition ID:R288185