Principal Scientist, Biologics Analytical R&D

Job Description

The Biologics Analytical Research & Development department of our Company's Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The Principal Scientist is a highly visible and impactful senior scientific role tasked with working closely with the group Director to define analytical strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs).•-

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We are looking for a team player with strong leadership skills and the passion for mentoring and working along others in a laboratory setting.- Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral.- A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.•An established reputation for scientific excellence supported by publications and external presentations is expected.---

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Qualifications -
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Education Minimum Requirements: -

• Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 10 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 14 years of experience in the pharmaceutical industry.•-

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Required Experience and Skills: -

• Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques-

• Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques-

• Strong background in analytical control strategy development and execution-

• 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 innovation in problem solving-

• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications-

• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development-

• 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.--

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

Preferred Experience and Skills: -

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

• Experience with qualification, validation, and transfer of assays to a GxP or regulated laboratory environment as listed in ICH Q2 and USP .-

• Experience with complex glycan analysis and link to mechanisms of actions.--

• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).-

• Knowledge and experience in Antibody Drug Conjugate method development-

• Established scientific reputation supported by publications and external presentations-

• Strong external network to benchmark competitors and equipment vendors-

• Experience in high-throughput experimentation and data-rich experimentation-

AR&D

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Required Skills:
Accountability, Accountability, Analytical Chemistry, Analytical Method Development, Anion Exchange Chromatography, Antibody Drug Conjugates (ADC), Assay Development, Bioanalysis, Bioanalytical Analysis, Capillary Electrophoresis (CE), Chromatographic Techniques, Clinical Judgment, Clinical Trials, Communication, Cross-Functional Teamwork, Dosage Forms, Drug Development, Ethical Compliance, Immunochemistry, Liquid Chromatography (LC), Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Pharmaceutical Management {+ 4 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:

EEOC Know Your Rights

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

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 .

You 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:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
06/6/2026
*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.

Requisition ID: R381546