Job Description
Associate Principal Scientist, Biologics Analytical Research & Development
Our Research Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough.
The Biologics Analytical Research & Development department (BAR&D) is seeking an Associate Principal Scientist position at the Rahway, New Jersey site. This role is a laboratory-based scientific role tasked with solving complex analytical challenges, to enable development of Biologics drug products. The successful candidate must function well in a collaborative, fast-paced, multidisciplinary team environment. The qualified candidate will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Responsibilities include development of new assay platforms, benchmarking current approaches/techniques to industry standards, and providing technical leadership of design of experiments and data interpretation. Applicants must be highly organized, possess excellent oral/written communications skills, display scientific leadership, and a desire to conduct research and publish. Experience leading small groups of technical personnel and analytical projects will aid in distinguishing candidates. Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred.
Qualifications
Education:
- Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field, B.S. with 10+ yrs, MS with 7+ yrs, or Ph.D. with 3+ yrs of relevant experience.
Required Experience and Skills:
Hands-on experience in separation sciences with chromatography, (e.g. SEC, RP, IEX, HILIC) and/or experience with capillary electrophoresis (CE) analysis (e.g. CE-SDS, iCIEF) for biologics.
Experience with residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
Ability to co-design, draft, execute/direct work related to method bridging, comparability, the setting of specifications, etc., from protocol to final report.
Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material and in support of product/process development per ICH Q2 (R2) guidance through method qualification.
Excellent oral and written communication skills; ability to work both independently and cross-functionally.
·Authoring and reviewing of SOPs, technical reports, publications and sections of regulatory filings (e.g., IND, BLA).
Experience with matrix management and peer to peer coaching.
Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
Preferred Experience and Skills:
- Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material and in support of product/process development per ICH Q2 (R2) guidance through method qualification.
- Broad knowledge on the panel of biologics assays, charge & size variants, glycans, purity/impurity.
- Understanding of protein degradation mechanisms and the link between analytical/orthogonal methodologies for analysis.
- Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP<1033>.
- Experience in representing analytical functional area on project teams.
- Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
- Experience in data analytics
**Required Skills: **
Analytical Method Development, Antibody Drug Conjugates (ADC), Assay Development, Biochemical Assays, Biological Assay Development, Capillary Electrophoresis (CE), Cell-Based Assays, Chromatographic Techniques, Clinical Trials, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Matrix Management, Molecular Biology, Molecular Microbiology, Optimism, Process Analytical Technology (PAT), Protein Analysis, Scientific Leadership, Teamwork, Therapeutic Proteins, Veterinary Medicine, Veterinary Pathology
**Preferred Skills: **
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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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
$142,400.00 - $224,100.00
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.
**Employee Status: **
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/13/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. **