Sr. Scientist, Analytical R&D

MSD Malaysia; Pennsylvania; Hybrid; USD 114,000 - 181,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Senior Scientist in Analytical R&D to oversee external analytics, ensure high-quality deliverables, and collaborate with cross-functional teams. The ideal candidate will have a strong background in large molecule development, and experience with a breadth of analytical methods, supporting biologics and vaccines development.

Benefits

Comprehensive medical, dental, and vision healthcare

401(k) retirement benefits

Paid holidays and vacation

Annual bonus and incentives

Qualifications

• Ph.D. in a relevant field with experience preferred.
• Master's with minimum 3 years, or Bachelor's with minimum 5 years of experience.
• Lab-based experience with compendial methods.

Responsibilities

• Oversee analytical deliverables at external partners including validations and technical oversight.
• Assist in building analytical capabilities at selected partners.
• Partner with stakeholders to review technical protocols and ensure compliance.

Skills

Adaptability

Analytical Method Development

Bioanalytical Analysis

Project Management

Regulatory Compliance Consulting

Education

Ph.D.

Master's degree with 3 years of experience

Bachelor's degree with 5 years of experience

Job description

Sr. Scientist, Analytical R&D page is loaded

Sr. Scientist, Analytical R&D

Apply remote type Hybrid locations USA - Pennsylvania - West Point time type Full time posted on Posted 2 Days Ago time left to apply End Date: June 19, 2025 (12 days left to apply) job requisition id R350416

Job Description

Job Description: Senior Scientist (R3), Analytical External Capabilities, Validation & Compliance (ECVC).

The selected candidate will work in the Analytical Research & Development (AR&D) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting a variety of large molecule drug substance, drug product, and adjuvant programs at various stages of development. The qualified candidate will be responsible for oversight of analytical outsourcing in support of development programs spanning from preclinical candidate up through late phase filing for biologics and vaccines. The candidate will partner with cross functional Development and Commercialization Teams (DCT’s) and external partners to establish and drive external timelines for program deliverables and will provide oversight of method development, method transfer and validation, as well as release and stability testing for multiple programs. The candidate will also partner with Process, Engineering, Quality, and interdivisional stakeholders to grow our relationships with select vendors by leveraging our company’s ways of working and transform them into strategic partners. This role represents an excellent opportunity for an analytical scientist seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs at any given time, and broaden their experience in large molecule development.

Primary Responsibilities:

• Oversight of analytical deliverables sited at selected external partners including analytical method validations/transfers, technical oversight, and resolution of analytical issues.

• Assist in analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners.

• Partner with internal AR&D stakeholders to author technical protocols, reports, and review technical documents.

• Ensure high quality documentation from external partners consistent with a compliance mindset.

• Execution of AR&D’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.

• Partner with cross functional DCT’s and Process Research & Development External Capabilities to manage externalized projects.

Education Minimum Requirements:

• A Ph.D. with relevant experience

• OR a Master’s degree with a minimum of 3 years of experience

• OR a Bachelor’s degree with a minimum of 5 years of experience

Preferred Experience & Skills:

• Effective communication, critical thinking, and leadership skills in a fast-paced dynamic environment.

• Lab based experience with compendial methods

• Experience with a variety of analytical methods, including biochemical, biophysical, and/or cell-based.

• Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines.

• Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.

• Working knowledge of large molecule CMC landscape including knowledge of GMP, ICH and relevant HA guidelines

• Travel (Domestic and/or International) up to 10% of time.

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

$114,700.00 - $180,500.00

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Applied Engineering, Assay Development, Bioanalytical Analysis, Biochemical Assays, Cell-Based Assays, Chromatographic Techniques, Compliance Reviews, GMP Environments, Immunoassays, Innovative Thinking, Management Process, Microbiology, Nuclear Magnetic Resonance (NMR) Analysis, Operating Models, Organizational Optimzation, Process Analytical Technology (PAT), Process Research, Productivity Management, Project Human Resource Management, Project Management, Project Resource Management, Regulatory Compliance Consulting {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/19/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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