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Job Description

Associate Principal Scientist, Biologics Analytical Research & Development

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. 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 of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility. The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.

The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The qualified candidate will be responsible for new method development, characterization, and analysis of process-related impurities derived from host cells or other bioprocessing steps during the manufacturing of biologics to support their early- and late-stage CMC development. Other responsibilities may include the development of custom host cell protein (HCP) reagents and highly sensitive immunoassays to monitor the clearance of problematic residual host cell proteins that may impact product safety, efficacy, and stability. The qualified candidate is expected to be a leader in new technology platform and scientific innovation, and also expected to communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate in cross-functional teams. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show 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:

+ B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 10 years of relevant experience; or Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience.

Required Experience and Skills:

+ Strong background and experience in immunoassay principles and the use of immunoassays for highly sensitive and specific detection of protein analytes including bioprocess derived impurities such as residual host cell proteins (rHCPs).

+ Extensive experience with process related residual assay development, qualification, implementation, troubleshooting and transfer using molecular biology and immunoassay techniques.

+ Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in biologics.

+ Knowledge or experience with 2D-SDS-PAGE, 2D-DIGE, or 2D-DIBE technologies for HCP antibody reagents characterization.

+ Knowledge or experience with polyclonal antibody purification from animal antisera and antibody conjugation techniques.

+ Familiar with different types of immunoassay such as ELISA, Western blot, and knowledge of different technology platforms for quantitative and semi-quantitative determination of protein analyte using immunoassay principles (Meso Scale Discovery, ForteBio, AlphaLISA, HTRF, Gyros, etc.).

+ Knowledge of protein chemistry and protein quantitation assays such as BCA, Bradford, and UV280 assay, familiar with protein analysis and purification skills such as SDS-PAGE gels, CE-SDS, SEC-HPLC, and affinity purification.

+ Knowledge of multiplex ELISA and the technology platforms for simultaneous multi-analyte detection and quantitation will be a plus.

+ A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.

+ Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

+ Experience with matrix management and peer to peer coaching.

+ Accurately and efficiently documentation of experiments.

+ Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills:

+ Knowledge of benchmarking HCP profiling and quantification technologies including proteomics and the use of proteomic LC-MS for protein profile comparison.

+ Knowledge of using statistics in data analysis and familiar with using statistical software for design of experiments.

+ 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.

+ Expertise in molecular biology techniques: DNA extraction, PCR (qPCR, RT-qPCR, droplet digital PCR, etc.) will be a plus.

+ Excellent track record in scientific publications, patents, or conference presentations.

\#AR&D

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$139,600.00 - $219,700.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Animal Vaccination, Applied Engineering, Assay Development, Bioanalysis, Biochemical Assays, Biological Assay Development, Blotting Techniques, Cell-Based Assays, Chromatographic Techniques, Communication, Cross-Functional Teamwork, DNA Extractions, Drug Development, External Collaboration, High Resolution Mass Spectrometry (HRMS), Immunoassays, Immunogenicity Assays, Immunoprecipitation, Liquid Chromatography-Mass Spectrometry (LC-MS), Management Process, Mass Spectrometry Analysis, Molecular Biology {+ 18 more}

Preferred Skills:

Job Posting End Date:

06/21/2025

*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.

**Requisition ID:** R348920