Executive Director, Biologics Analytical Research and Development - Military Veterans

Job Description

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, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for all of our company's pipeline. Our Discovery Interface team works closely with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology, and seeks to embed developability/manufacturability considerations into early research discussions in order to enable more seamless and rapid progression of candidates from Discovery into Process Development and Clinical Supply Manufacturing.

We are seeking an innovative, highly motivated, and experienced Associate Principal Scientist to join us at our research and development site in West Point, PA (outside Philadelphia).

The candidate will be responsible for scientific/technical leadership of a downstream/bio-purification process development team, and will also be a critical member of cross-functional program/project teams. This will require frequent collaboration with cross-functional teams including colleagues in Discovery, Analytical, Formulation, and Enabling Technologies. The candidate should have a strong background in recombinant protein therapeutic/vaccine design and understanding of various purification modalities, including but not limited to column chromatography (SEC, IEX, Affinity, MMC, HIC, etc.) and filtration unit operations (depth filtration, sterile filtration, viral filtration, TFF), as well as advanced knowledge in peptide/protein handling and purification techniques. Alternatively, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Preferably, the candidate will have experience with both recombinant protein purification and conjugation process development. Experience with affinity chromatography is also preferred.

Primary responsibilities include, but are not limited to:

• Lead early downstream process design and development for recombinant subunit and/or conjugate vaccine products.


• Contribute to the development of new principles, concepts, methods, and workflows to enable rapid early process development for new molecules emerging from Discovery.


• Design, execute, and analyze process development experiments to maximize understanding of recombinant subunit and/or conjugate vaccine production processes, thereby de-risking later stage process/product development.


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


• Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of downstream/bio-purification process development for vaccines and advanced biotechnologies.


• Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.


• Analysis of downstream/bio-purification experiments through basic analytical techniques including SDS-PAGE, UV-Vis, HPLC, Light Scattering


• Data interpretation and presentation, manuscript/patent preparation

Education Minimum Requirement:

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

Required Experience and Skills:

• For BS candidates, at least seven (7) years of experience in a pharmaceutical or biotechnology-related position.


• For MS candidates, at least five (5) years of experience in a pharmaceutical or biotechnology-related position .


• For PhD candidates, at least three (3) years of experience in a pharmaceutical or biotechnology-related position.


• Must have strong scientific and hands-on understanding of a wide variety of common downstream unit operations for large molecule purification (e.g., depth filtration, chromatography, tangential flow filtration), biotherapeutic and/or vaccine production, and purification process development.


• At least 5 years of hands-on experience in the optimization of downstream processes


• Some prior experience with statistical design of experiments (DOE) and/or algorithmic process optimization.


• Strong understanding of, or hands-on experience in, cGMP manufacturing.


• Ability to work effectively both independently and in a team-focused environment.


• Well-developed organizational, record-keeping, and timeline/resource-mapping skills.

Preferred Experience and Skills:

• Experience in purification unit operations using AKTA platform (or similar FPLC system)


• Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates)


• Demonstrated knowledge of peptide and protein biochemistry (e.g., structure, function, immunology), and cutting-edge methodologies related to protein isolation/purification


• Sound understanding of bioprocess scale-up principles


• Experience in mentoring others and leading small technical development teams


• Experience in authoring and reviewing CMC regulatory documentation

The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also 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 comply with all required training and maintain a focused attention on laboratory safety for him/herself and his/her team.

Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Some travel may be required. This position may require occasional off-hour and weekend work.

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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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:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
BSL-2

Job Posting End Date:
09/14/2024
*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.