Principal Analytical Scientist, Analytical Commercialization, Development and Supply

Job Description

Our company is seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located in the US. -The successful candidate will be joining a group of innovative scientists with broad deliverables including, but not limited to, API and Drug Product analytical problem-solving and optimization, trace impurity quantitation, characterization studies, and cross-functional initiatives. The individual will also drive innovation in instrumentation and methodologies to enable efficient solutions to solve analytical problems within a regulated supply environment.

Responsibilities include but are not limited to:

• Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance.
• Excel in impurity isolation, unknown peak identification, characterization of degradation pathways, and trace impurity quantitation (e.g., carcinogens/mutagens such as nitrosamines).
• Utilize specialized instrumentation such as mass spectrometers and other spectroscopic techniques.
• Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the manufacturing network to:
  • Identify issues and gaps
  • Implement solutions to troubleshoot and optimize laboratory test methods, workflows, and materials
  • Ensure a compliant, robust, and responsive supply chain
• Introduce and lead strategic initiatives related to technical advancement, compliance, and business improvements.
• Demonstrate the ability to influence meaningful outcomes through leadership and collaboration.
• Maintain a deep understanding of the regional regulatory and business environment, including:
  • API and Drug Product development needs
  • GMP compliance in commercial manufacturing
  • Data integrity principles
• Coach and mentor staff on analytical techniques, problem solving, and data integrity as needed.
• Share best practices across the company to enhance overall capabilities.
• Report to the SAS E2E Investigation Support lead.
• Bring a strong technical background combined with superior problem-solving skills and an innovative mindset.
• Exhibit exceptional leadership abilities and strong knowledge of cGMP and Data Integrity.
• Uphold strong values essential to fostering and contributing towards the company vision.

Minimum Education Requirement and Experience:

• Bachelor of Science (BS) degree in chemistry or related sciences with twelve (12) years of combination experience in the following: technical background in analytical chemistry and instrumentation, experience in leading and overseeing analytical investigations in a regulated environment, and leadership experience in the pharmaceutical manufacturing industry OR

• Master of Science (MS) degree in chemistry or related sciences with ten (10) years of combination experience in the following: technical background in analytical chemistry and instrumentation, experience in leading and overseeing analytical investigations in a regulated environment, and leadership experience in the pharmaceutical manufacturing industry OR
• Ph.D. degree in chemistry or related sciences with six (6) years of combination experience in the following: technical background in analytical chemistry and instrumentation, experience in leading and overseeing analytical investigations in a regulated environment, and leadership experience in the pharmaceutical manufacturing industry

Required Skills and Experience:

• Author analytical procedures, method development, validation and transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents, etc.
• Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
• Experienced in trace impurity quantitation, impurity isolation, and structure characterization.
• Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.
• Identify and champion continuous improvement for the existing workflows.
• Have a working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control.
• Have working knowledge of developing various analytical techniques (e.g., chromatography, mass spectrometry, spectroscopy) and product specification to support drug substance and drug product initiatives.-
• Have working knowledge of the process by which the products are brought to market.
• Demonstrate strong collaboration with cross-functional partners both internally and externally and skill to influence outcomes.--
• Have experience working with CMOs and CROs.
• Have a working knowledge of CMC filing requirements.
• Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
• Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
• Self-motivated to take ownership and accountability of issues and drive them to completion.
• The ability to speak up and raise issues and help to drive resolution.
• The ability to quickly adapt to changes and develop appropriate plans for managing risks.

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
$169,700.00 - $267,200.00

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 .

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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Academic Presentations, Academic Presentations, Analytical Chemistry, Analytical Decision Making, Analytical Instrumentation, Analytical Method, Analytical Method Development, Analytical Skills, Analytical Thinking, Analytical Work, Analytics Insights, Bioanalysis, Biochemical Analysis, Bioconjugation, Chemometrics, Chromatography, Communication, Computational Chemistry, Creativity, Data Analysis, Data Integrity, Gas Chromatography-Mass Spectrometry (GC-MS), GMP Compliance, High-Throughput Experimentation (HTE), Instrumentation {+ 16 more}

-Preferred Skills:

Job Posting End Date:
09/13/2025
*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: R359712