Director, Large Molecule Primary Stability & Critical Reagents

Job Description

The Large Molecule Analytical Validation (LMAV) team within Analytical Research & Development (AR&D) is seeking a highly motivated and experienced Director to lead the primary stability strategy and manage critical reagents for our Company's Large Molecule Pipeline design. The primary role of the successful candidate will be to develop, implement & manage stability strategies and to manage the commercialization of critical reagents.

The focus on primary stability will lead the team to ensure implementation and execution of stability studies, evaluating stability data (including statistical evaluation and preparation of data in regulatory filings), and investigating atypical and out of specification stability results as needed. The management of critical reagents will focus on strategic development, preparation, qualification, implementation, and knowledge transfer of Biological Critical Reagent (BCR)/Reference Standards (RS) to the commercial hub.

Multiple cross divisional close partnerships are a pivotal part of the role to ensure successful commercialization of the pipeline. The position will lead a multi-region and country team of 10-15 FTE.

* Note: This position is available in West Point, PA; Rahway, NJ; or Ireland based on candidate's current domestic location preference.

Responsibilities include, but are not limited to, the following:

• Cultivate and foster relationships with key partners across divisions to build a collaborative relationship that aligns to the End-to-End Transformations, addressing the needs of the pipeline
• Leadership & management of a diverse team
• Manage relationships with key partners
• Build collaborative partnerships to align/develop the stability & critical reagent strategy to address the needs of the pipeline
• Strategic alignment of cross functional teams (e.g., B-AR&D, V-AR&D, Global Quality Analytical Sciences, Quality Systems & Compliance) to identify stability risks, remove obstacles, develop solutions, and perform assessments to ensure a robust stability program
• Cross divisional collaboration on critical reagents, partnering with Global Quality Analytical Sciences critical reagents team Develop critical reagent strategies for large molecule pipeline programs to commercialize reagents to the commercial hub, while managing the preparation, qualification, implementation, technical writing, and knowledge transfer
• Lead the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching
• Interface with key stakeholders to drive innovation, seek process efficiencies and solve complex challenges that have broad impact on the business
• Alignment of cross-divisional sponsorship, develop communication plans and escalation of issues, as required. Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects

Education:

• B.S. in science or related discipline with 12 years of relevant experience in the biopharmaceutical industry
• M.S. science or related discipline with eight (8) years of relevant experience in the biopharmaceutical industry
• Ph.D. in science or related discipline with six (6) years of relevant experience in the biopharmaceutical industry

Required:

• A minimum of five (5) years of experience focusing on stability programs or critical reagents
• Provide strategic, tactical and technical leadership for Analytical Research & Development focusing on the end-to-end responsibilities for stability programs and critical reagents
• Ability to work in a high paced team environment with cross-divisional & functional interactions
• Ability to deliver complex objectives under challenging timelines in a rapidly changing environment
• Motivates team members and promotes the value of working together as a team and relationship building, using the diverse perspectives of others to generate ideas.
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills

Preferred:

• M.S. or Ph.D.
• Experience with qualification, validation, and transfer of assays per ICH and USP
• Experience with large molecule modalities (i.e., biologics, vaccines, ADC) is a plus

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.

#AR&D

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 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, 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:
$159,200.00 - $250,700.00

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.

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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:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Requisition ID:R252597