Merck & Co Hiring for Principal Scientist, Late Stage Analytical Working Group Lead (Hybrid) job in Kenilworth Full Time

Principal Scientist, Late Stage Analytical Working Group Lead

Analytical Research and Development at our company’s Research Laboratories is seeking an experienced-analytical program management professional, to join our Large Molecule Analytical Validation team. The primary responsibility is to lead and oversee the development and delivery of a program specific analytical strategy and management of analytical timelines and deliverables for monoclonal proteins or other complex therapeutic proteins in our company’s biologics and vaccines portfolio, from clinical candidate through commercialization. -In this role, you will work closely with groups in MRL Biologics and Vaccines Analytical Research and Development, Global Quality and Regulatory Affairs-CMC to support commercialization of our company’s large molecule products.-

Job Responsibilities:

• Develop the analytical strategies and manage all analytical deliverables for a given program(s) in a matrix team environment
• Manage and serve as primary point of contact for assigned programs to management and key stakeholders (program Development and Commercialization Teams, Global Quality, large molecule analytical development organizations, CMC Regulatory Affairs)
• Maintain and communicate timelines using project management tools
• Identify and communicate risks, issues, and opportunities proactively and develop mitigation strategies.
• Support subject matter experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections
• Lead or assist in the development and refinement of above-program strategic plans and objectives, for example Quality by Design, specifications, critical reagents, etc.

Required Qualifications:

• Education & experience:- B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals or related field with 10 years of relevant experience; or Master’s degree with 7 years of relevant experience; or Ph.D. with 4 years of relevant experience.
• Project management experience tracking, supporting and communicating timely delivery of milestones
• Ability to work independently and within cross-functional teams, in-person and remotely
• Effective communicator, influencer and partner
• Strong knowledge and experience in application of current Good Manufacturing Practices to analytical activities within a quality management system, and with health authority submissions and interactions
• Able to travel domestically/internationally (5-10% of time)

Preferred Qualifications:

• Prior experience managing therapeutic product analytical programs
• Previous experience leading or working in a quality control or analytical development organization
• Familiarity with typical analytical techniques used for large molecule batch release and stability testing
• Experience using project management, validation and EDMS solutions (e.g. scheduling tools, PowerBI, Kneat, Trackwise

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 separationpackage, 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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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:

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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 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:
$144,320.00 – $227,100.00

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

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R258525