Principal Scientist, Analytical R&D

Job Description

The Materials and Biophysical Characterization group in Analytical Research and Development is seeking a highly self-motivated and innovative scientist with deep knowledge and problem-solving skills in biotherapeutics characterization.  The Materials and Biophysical Characterization team is responsible for building the mechanistic understanding of the interplay between formulation composition, stability, device, and process to ensure robustness and quality of drug substances and drug products in the biotherapeutics pipeline.

As a Principal Scientist, you will be leading and/or contributing to projects in a diverse biotherapeutics pipeline by developing and implementing biophysical and particle characterization tools.  In addition to your responsibilities as an individual contributor, you will also serve as a senior scientific leader and will be expected to mentor other team members in designing experiments, interpreting data, and delivering results in a timely manner.  You are expected to use your scientific expertise to find creative solutions to challenging problems which require deep analytical insight and critical thinking. Additional responsibilities include authoring technical reports and regulatory documents, presenting technical data, and project management. You will have the opportunity to conduct and lead independent research, publish research findings, present at scientific conferences, and engage with various external scientific societies/organizations. This is an excellent growth and learning opportunity to work in an exciting, collaborative environment with a wide array of scientists from different divisions and make significant contributions towards our life-saving medicines.

Education Minimum Requirement: 

• Ph.D. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years of relevant industry experience.

• OR M.S. with a minimum of 10 years of relevant industry experience. 

 

Required Experience and Skills:

• Extensive experience in the analysis of biologics, protein/peptide stability, protein-protein interactions

• Extensive experience with subvisible particle characterization methodologies and analytical control strategy development and execution.

• Strong background in biophysical characterization assay development and implementation (e.g. Circular Dichroism (CD), Infrared Spectroscopy (IR), Differential Scanning Calorimetry (DSC), Analytical Ultracentrifugation (AUC))

• Understanding of protein aggregation mechanisms and link between analytical methodologies for analysis.

• Demonstrated ability to develop talent through good mentoring skills.  Experience with matrix management and peer-to-peer coaching

• Demonstrated ability for taking initiative, creativity, and innovative problem solving.

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

• A strong team player with excellent oral and written communication skills; ability to work both independently and cross-functionally.

• Experience with authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.  

• Established scientific reputation and external influence, supported by publications, patent authoring, external presentations at scientific meetings, membership in (or leading) cross-company working groups or consortia

 

Desired Experience and Skills:

• Experience characterizing various biologics modalities (e.g. mAb, antibody-drug conjugates, fusion proteins, peptides)

• Experience with characterization of lyophilized protein formulations

• Experience with extraneous matter (EM) investigations for particle identification

• Experience/knowledge in formulation development and relevant analytical method development

Required Skills:

Analytical Method Development, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biomedical Engineering, Biomedical Sciences, Chemical Biology, Chemical Engineering, Chromatographic Techniques, Circular Dichroism (CD), Clinical Judgment, Conducting Experiments, Cross-Functional Teamwork, Differential Scanning Calorimetry (DSC), Dosage Forms, Ethical Compliance, Infrared Spectroscopy, Liquid Chromatography (LC), Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Pharmaceutical Sciences, Protein Interactions, Spectrophotometry {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 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:

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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

$156,900.00 - $247,000.00

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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/4/2026

*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.