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Job Description

We are seeking an esteemed leader in RNA-based vaccine development as a Director in the Discovery Interface & New Platforms group, based in West Point, PA.

Our department, Vaccines and Advanced Biotechnologies (VAX) Process R&D, is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline at our company, 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.

Under the direction of the Executive Director, this role will lead process development efforts for RNA-based vaccine candidates. The successful candidate will serve as the technical lead and people manager for a group of upstream and downstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for plasmid starting materials and RNA-based vaccine production. These responsibilities also include the manufacture of cGMP clinical bulks and tech transfer to clinical or commercial manufacturing facilities. Duties may include pre-clinical, clinical, and commercial process development, process scale-up and engineering, development of innovative process monitoring and/or process control strategies. The successful candidate will also be responsible for representing VAX PR&D as a bioprocess expert in internal, cross-functional project teams and external conferences/consortia as well as due diligence for business development. This role will closely collaborate with leaders within VAX PR&D as well as with partner groups within analytical development, drug product development, enabling technologies, discovery, and commercial manufacturing.

Primary responsibilities include, but are not limited to:

• Technical lead and direct or indirect people manager of a team

• Develop program strategies and guides future technological investment activities based on regulatory and industry trends.

• Advance a culture of scientific excellence, by serving as a subject matter expert (SME) in the areas of plasmid and/or RNA process development, characterization, and technology transfer.

• Drive the development of new principles, concepts, and methods to enable accelerated process development, process scale-up, and technology transfer to meet program deliverables.

• Support/lead strategic initiatives and drive innovation in vaccine and advanced biotechnology process development.

• Represent functional area in cross-functional and strategic teams engaged in novel vaccine and advanced biotechnology development.

• Provide mentorship, technical oversight and strategic guidance to direct reports.

• Author/review required regulatory and technical documentation.

The successful candidate will be expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to maintain focused attention on compliance training and laboratory safety for his/her team.

Travel may be required.

Education Minimum Requirement:

• Must have a BS or MS or PhD in engineering or biological sciences

Required Experience and Skills:

• For BS, at least twelve (12) years of experience in biotechnology related position

• For MS, at least ten (10) years of experience in biotechnology related position

• For PhD, at least eight (8) years of experience in biotechnology related position

• Must have strong scientific understanding of process development principles.

• Excellent scientific understanding of fermentation, plasmid purification, in vitro transcription (IVT), and/or RNA purification techniques

• At least 4 years of hands-on experience in RNA product process development.

• Prior experience of statistical design of experiments

• Strong understanding and experience in technology transfer and cGMP manufacturing at clinical or commercial scale

• Experience in mentoring/managing teams of scientists/engineers

• Sound understanding of the regulatory guidelines governing cGMP manufacture

Preferred Experience and Skills:

• Prior experience in fermentation, IVT, and nucleic acid purification process development

• Prior experience in RNA-based vaccines

• Strong foundation in engineering principles and their application to bioprocess unit operations

• Prior experience in the development of lab, pilot, and commercial scale processes

• Prior experience in implementing PAT approaches to solve bioprocess challenges

• Project management experience including participation or preferably leadership of technical working groups

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life.

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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

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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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

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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”.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/24/2024

*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: 05/24/2024

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: R293669