Principal Scientist, Biological Characterization Analytical R&D

Job description

**Job Description**

The Analytical Research & Development department of our Company Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility.

We are looking for a collaborative, self-motivated scientific leader with expertise in biological characterization and structure function assessment of biologic modalities (e.g. mAb, antibody-drug conjugates, fusion proteins, immunomodulatory molecules, immune-cell engagers, and complex peptide/protein modalities).

We collaborate closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing, to drive effective problem solving and innovation across the Biologics pipeline in a fast-paced, multidisciplinary environment.

We value rigorous scientific exploration, cross-functional collaboration, creative-thinking and dedication to building strong and operationally excellent teams.

Our ability to excel depends on the integrity, expertise, innovation and teamwork of our scientists.

We strive to create an environment of mutual respect, diversity, encouragement and collaboration.

As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing your career.

**Responsibilities include, but are not limited to:**

+ Work closely with the group Director to shape and execute strategy for biological characterization in all stages of clinical development, as well as for commercialization and in line commercial projects.
+ Lead development and implementation of robust non-GMP characterization methods, using quality by design principles and with focus on comprehensive life-cycle management.
+ Mentor and supervise junior colleagues; coach, and develop talent within the group, contribute to employee career development; build independent ownership and evolution of specializations within the team.

Inspire, encourage and support scientific excellence.
+ Foster strategic thinking to anticipate and support key partner needs.

Utilize effective networking to solve complex scientific and technical problems.
+ In active collaboration with management, contribute to continuous improvement in team productivity via enhancing effective organizational skills, accurate resource planning and prioritization, utilization of best practices and standardization of processes, and evaluation of innovative scientific and technological tools.
+ Partner with management and project teams to help drive pipeline progression and strategic initiatives.

Contribute to assessment of capability gap(s) and expand toolbox for characterization of new biologics modalities for structure-function understanding.
+ Champion compliance and safety while promoting a culture of diversity, equity, and inclusion.
+ Stay updated on the scientific, industry and regulatory landscape, actively publish and engage with the scientific community to influence the field.

**Minimum Education Requirements:**

+ Ph.D. with 8+ years, MS with 10+ years, or BS with 14+ years of experience in Cell Biology, Molecular Biology, Immunology, Pharmacology, Translational Science, Biotechnology or a related field.

**Required Experience, Skills, and Competencies:**

+ Stay updated on the scientific, industry and regulatory landscape, actively publish and engage with the scientific community to influence the field.
+ Demonstrated ability to develop talent, supervise, coach and mentor others.
+ Strong leadership skills and record of effective cross-functional collaboration, demonstrating initiative, creativity, and innovation in problem solving.
+ Strong fundamental knowledge and subject matter expertise in cell biology and immunology.
+ Expertise in design and development of biological characterization assays for therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or cell and gene therapy products.
+ Expertise in comprehensive mechanistic structure function understanding and impact on biological activity.
+ Strong expertise in interpretation of characterization data in context of broader process and product development, critical reagents characterization and overall analytical control strategy.
+ Ability to adapt to and prioritize complex objectives under tight timelines in a dynamic cross-functional environment.
+ Established strong scientific reputation for scientific excellence supported by publications, patent authoring, external presentations at scientific meetings, membership in (or leading) cross-company working groups or consortia.

**Preferred Experience & Skills:**

+ Expertise in authoring regulatory guidance and quality standards, authoring and reviewing of regulatory submissions and responses (IND and BLA) and interacting with Health Authorities.
+ In-vitro immunogenicity assessment, with focus on risk assessment for biologics and novel biologic modalities.
+ Molecular Biology and cell line engineering, gene engineering, CRISPR.
+ In-vitro characterization assays for pharmacokinetics (PK) assessment.
+ Flow cytometry, confocal microscopy and high-content imaging.

#AR&D

**Required Skills:**

Accountability, Accountability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biotechnology, Chromatographic Techniques, Clinical Judgment, Communication, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Flow Cytometry, Gene Therapy, Genetic Engineering, Immunoassays, Immunochemistry, Immunogenicity Assays, Immunology, Liquid Chromatography (LC), Matrix Management, Mentoring Staff, Method Validation, Microbiology, Molecular Biology {+ 5 more}

**Preferred Skills:**

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/)

**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

$153,800.00 - $242,200.00

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:**

**VISA Sponsorship:**

**Travel Requirements:**

**Flexible Work Arrangements:**

Not Applicable

**Shift:**

**Valid Driving License:**

**Hazardous Material(s):**

**Job Posting End Date:**

11/17/2025
***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:** R369707

Required Skill Profession

Other General