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Executive Director, Discovery Interface

3 months ago

Arvada, Colorado, United States Merck Full time

Job Description

We are seeking an esteemed leader in the process development and manufacturing of vaccine drug substances (DS) as an Executive Director for Discovery Interface & New Platforms (DINP), located in West Point, PA.

Our department (Vaccines and Advanced Biotechnologies, VAX) Process R&D is responsible for the development and clinical manufacturing of DS and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. 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 Executive Director will be responsible for interfacing with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology. This individual will play a pivotal role in advancing our pipeline and establishing scientific excellence by adopting new modalities and cutting-edge technologies.

Additionally, the role encompasses enhancing our external collaboration network (academia, industry, and NGOs), and guiding our scientific presence externally through publications and leading conferences.

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

Responsibilities:

Discovery interfacing

  • Establish early and robust interfaces with related Discovery organizations such as Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology.
  • Engage early in pre-clinical space to influence antigen and molecule design, build developability and manufacturability from the origin, and accelerate pipeline to PCC and FIH as needed.

Innovation and Pipeline Advancement

  • Rapidly adopt new modalities in the early Discovery stage or from licensed-in assets.
  • Establish phase-appropriate new platforms to facilitate pipeline progression and scientific excellence.
  • Drive pipeline advancement and innovation through proactive collaboration with internal and external organizations

Scientific Excellence

  • Establish scientific excellence for new modalities and early assets.
  • Build world-class Nucleic Acid platforms, including DNA, mRNA, and circular RNA.
  • Build state-of-the-art tools for process understanding and robustness, including Systems Biology.

Education:

  • PhD in biochemistry, biochemical engineering, pharmaceutical sciences, or a relevant field.

Required Experience and Skills:

Business and Technical Expertise

  • A minimum of 12 years of experience in Discovery or DS process development for vaccines/ biologics, with exposure to all stages and aspects of the product life cycle
  • Solid record of interfacing with Discovery organizations in infectious diseases and other therapeutic areas (oncology, neuroscience, immunology etc.) for target validation and proof of biology.
  • Solid skills and experience in antigen/antibody design, including protein engineering and protein modelling.
  • Solid skills and experience in modality/ host selection, matching selected target with suitable modalities and expression systems.
  • Demonstrated capability and track record of applying Systems Biology to advance pipeline.
  • Solid track record of direct Chemistry, Manufacturing, and Controls (CMC) leadership leading to multiple successful Phase 1 regulatory submissions for vaccines/biologics.

Leadership and Impact

  • Demonstrated leadership and communication capability to strongly influence senior leaders across functional areas and steer strategy and execution.
  • Demonstrated expertise in addressing complex challenges in pipeline and life cycle management through critical thinking, innovation, scientific rigor, and cross-functional collaboration.
  • Demonstrated capability and organizational intelligence to lead changes under complexed and ambiguous situations.
  • Solid track record of building high performance team to advance complexed pipeline and technology development.
  • Must be recognized in the pharmaceutical industry, through publications/presentations, for subject matter expertise.

Preferred Experience and Skills:

  • Extensive experience in upstream, downstream, analytical development, and continuous manufacturing for vaccines/biologics, with in-depth domain knowledge in one of these areas.
  • Proficient with major cell substrates ( E.coli, yeasts, HEK293, Vero, CHO, etc) and modalities (LVV, viral vectors, RNA, protein subunits, conjugates, etc).
  • Strong knowledge of global regulatory requirements for vaccines
  • Working knowledge on DPI and adjuvant development and innovation.
  • Consistently delivers breakthrough results aligned with business needs and advancing the field.

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.

PRD

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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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EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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".

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:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/28/2024

*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.

Job Posting End Date:06/28/2024

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:R265779