Associate Principal Scientist, Biologics Potency AR&D

Job Description

The Analytical Research and Development, Cell Based Sciences team in Rahway, NJ is seeking a motivated scientist with technical expertise in Biologics Potency assays in drug Development. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for the development of therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or new modality-based products.

The successful candidate is expected to provide scientific expertise, and creativity to solve complex project problems across the large molecule portfolio. They will be accountable to deliver and inspire scientific evaluation and implementation of innovative and disruptive technologies and approaches. Responsibilities include assay development, representing the group on product development teams and supporting defining the potency strategy for a portion of our large molecule portfolio, method development and testing, and scientific mentoring. The candidate will be expected to effectively communicate with stakeholders in partner organization and to management and governance teams.

Education Minimum Requirement:

• Ph.D. in analytical chemistry, molecular biology, cell biology, or related field with a minimum of 4 years of industry experience in the Biopharmaceutical Industry.

• OR M.S. with a minimum of 8 years of experience in the Biopharmaceutical Industry.

• OR Bachelors with a minimum of 12 years of experience in the Biopharmaceutical Industry.

Required Experience and Skills:

• Expertise in cell biology and immunology, with application to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities, preferably with experience in new modality-based therapy development.

• Experience in mentoring peers.

• Expertise in a variety of functional potency assay technologies, such as cell line engineering to build reporter gene assays, cytotoxicity assays.

• Expertise in binding assays such as immunoassays.

• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development.

• Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities is a plus.

• External scientific engagement that may include a combination of publications, industry white paper contributions, presentations at scientific meetings.

• Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.

• Excellent verbal and written communications skills.

#AR&D

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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, Monday - 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”.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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.

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Regular

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