Associate Principal Scientist, Biologics Potency AR&D
Associate Principal Scientist, Biologics Potency AR&D
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$ 139600 - 219700
1 Vacancy
Job Description
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 will be accountable to deliver and inspire scientific evaluation and implementation of innovative and disruptive technologies and 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 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.
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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 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
$139600.00 - $219700.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Analytical Method Development Applied Engineering Assay Development Biological Assay Development Biologics License Application (BLA) Biopharmaceutical Industry Biopharmaceuticals Business Cell-Based Assays Cell Physiology Chromatographic Techniques Cross-Functional Teamwork External Collaboration High Resolution Mass Spectrometry (HRMS) Immunoassays Immunotherapy Liquid Chromatography-Mass Spectrometry (LC-MS) Management Process Mass Spectrometry Analysis Molecular Biology Monoclonal Antibodies Optimistic Attitude Polyclonal Antibody Production 5 morePreferred Skills:
Job Posting End Date:
07/7/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
