Distinguished Scientist, Biologics Process Development

Job Description

We are seeking an exceptional scientific leader for the role of Distinguished Scientist (equivalent to the Executive Director level) in Biologics Process Development (BPD) group within the Biologics Process Research and Development (BPR&D) organization at Kenilworth, NJ.

The candidate will serve as the overarching scientific leader in BPD, the group responsible for developing upstream and downstream fed batch/ continuous processes for biologics in our company's pipeline. The incumbent will be responsible for conceiving our end-to-end scientific strategy, establishing a relevant technology roadmap, and subsequently facilitating its execution. The candidate will be an SME in the upstream or downstream Process Development and will play a key role in reinforcing and evolving our scientific leadership in biologics development and manufacturing. The candidate will collaborate with other development areas (including Analytical Development and Drug Product Development) as well as Discovery, Clinical Manufacturing, Commercial Manufacturing, Regulatory, and Marketing teams to progress our pipeline and platforms for biologics including antibodies, bispecifics, fusion molecules, and antibody drug conjugates.

Additionally, the role encompasses maintaining and enhancing our external collaboration network with academia, industry, and NGOs, and strengthening our scientific presence through publications and conferences. The candidate will participate in external regulatory forums to bring the evolving knowledge to our company and influence regulatory landscape related to the manufacturing and launch of biologics. The candidate, working alongside key partners, will also influence the strategy for data analyses and modeling approaches for BPD organization.

The candidate will be a member of the BPD Leadership Team and report directly to the Executive Director (Head of Bioprocess Development). The incumbent will be expected to represent the group in due diligence and regulatory activities. The candidate will also mentor and develop scientific talent and high-performing teams with members of varied background and advance our company's commitment to a diverse and inclusive work environment.

Education:

• PhD in Chemical/Biochemical Engineering, Biochemistry, Biology, Pharmaceutical Sciences, or a relevant field.

Required Experience and Skills:

• A minimum of 15 years of experience in drug substance Process Development for biologics/ vaccines; exposure to all stages and aspects of the product life cycle is required.

• Extensive experience and in-depth knowledge in upstream, downstream, analytical development, or/and continuous manufacturing for biologics/vaccines.

• Proficient with major cell type (E.coli, yeast, CHO, etc.) used for producing biologics.

• Experience in CMC or program management, with proven track record of multiple successful submissions for biologics/vaccines.

• Excellent understanding of mechanistic modeling of downstream processes, AI/ML, metabolic engineering, system biology, or/and data analyses strategies.

• Strong knowledge of global regulatory requirements for biologics/vaccines.

Preferred Experience and Skills:

• Recognized as a scientific leader nationally/ internationally for expertise in biologics/vaccines Process Development, exemplified by a track record of successful collaboration with industry and academia, recognition of work via professional organizations, or/and demonstration of research impact via citations, awards, and nominations.

• Proven record to define a compelling vision to push the boundary of the biologics field, derive the scientific strategy accordingly, and implement practical solutions in Process Development and manufacturing settings.

• Working knowledge on Analytical and Drug Product development and manufacturing and relevant innovations.

• Exceptional scientific and communication abilities to influence senior management across functional areas to steer scientific strategy and policy.

• Demonstrated expertise in addressing complex challenges for pipeline management through critical thinking, innovation, scientific rigor, and cross-functional collaboration.

• Consistent delivery aligned with business/strategic needs while advancing the field.

• Demonstrated ability to apply growth mindset to promote innovative culture within teams and partnerships.

• Proven track record of developing diverse talent and building high performance teams.

• Demonstrated insight and organizational intelligence to lead changes under ambiguous situations.

PRD

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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$193,440.00 - $304,500.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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 Specified

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:R267614