Senior Specialist, Raw Material Analytical Characterization

Job Description

Position Summary

The Biologics Raw Materials team within Biologics Drug Substance & Commercialization (BDSC) is seeking a highly motivated scientist to lead analytical characterization and technical oversight of raw materials used in biologics manufacturing. This role will focus on understanding and controlling raw material variability through analytical characterization, risk assessment, and supplier engagement to ensure robust manufacturing processes, product quality, and supply continuity.

The successful candidate will apply expertise in analytical chemistry, materials characterization, and bioprocessing to identify critical material attributes (CMAs), evaluate supplier and lot-to-lot variability, and develop risk-based strategies for raw materials used in cell culture media, feeds, and other critical manufacturing inputs. The role requires close collaboration with Manufacturing, Quality, Procurement, Supply Chain, Regulatory Affairs, Process Development, and external suppliers.

Key Responsibilities

Raw Material Characterization & Risk Assessment

• Develop raw material characterization program for raw materials used in biologics manufacturing, including cell culture media, feeds, amino acids, vitamins, trace elements, salts, and excipients.
• Identify and assess Critical Material Attributes (CMAs) and their impact on process performance, product quality, and Critical Quality Attributes (CQAs).
• Develop characterization strategies to evaluate composition, purity, impurity profiles, stability, and lot-to-lot variability.
• Investigate sources of raw material variation and work with process teams to better understand potential impact on cell growth, productivity, glycosylation, aggregation, potency, and product quality.
• Apply risk-based approaches to prioritize materials based on process impact, product quality risk, supplier performance, traceability, and supply chain complexity.
• Support qualification of new materials, suppliers, and alternate sourcing strategies.
• Strong knowledge of compendial methods and pharmacopeial standards (USP, EP, JP, BP), including their application to raw material testing and characterization. Demonstrated ability to evaluate, harmonize, and standardize test methods across compendial, supplier, and internal laboratories.

Analytical Characterization

• Develop analytical methods used for raw material characterization.
• Apply advanced analytical techniques to identify and quantify impurities, trace contaminants, degradation products, and supplier-to-supplier differences.
• Utilize orthogonal analytical approaches to generate comprehensive material characterization packages.
• Evaluate and implement innovative analytical technologies that improve understanding of raw material variability.

Cross-Functional & External Collaboration

• Partner with Manufacturing, Process Development, Quality, Procurement, Supply Chain, Regulatory Affairs, and external suppliers to assess and mitigate material-related risks.
• Support technology transfers, quality investigations, supplier assessments, and regulatory submissions.
• Communicate analytical findings, technical risks, and recommendations to scientific and business stakeholders.
• Collaborate with suppliers to improve raw material quality, consistency, transparency, and supply reliability.

Regulatory & Compliance Support

• Support regulatory filings, inspections, and agency responses through scientific assessments and analytical data packages.
• Ensure analytical methodologies align with GMP requirements and current regulatory expectations.
• Contribute to raw material control strategies consistent with ICH Q8, Quality by Design (QbD), and risk-based manufacturing principles.

Education and Experience

• Bachelor’s, Master’s, or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, Materials Science, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline.
• Bachelor’s degree with 6+ years of relevant experience; OR Master’s degree with 4+ years of relevant experience; OR Ph.D. with no industry experience.
• Relevant experience may include biopharmaceutical, biotechnology, analytical sciences, materials characterization, process development, manufacturing support, or quality operations.

Required Skills

• Expertise in analytical chemistry, materials characterization, or biophysical characterization.
• Experience developing and applying analytical methods to characterize complex materials and sources of variability.
• Understanding of raw material variability and its impact on bioprocess performance and product quality.
• Strong scientific problem-solving, data interpretation, and investigation skills.
• Proven ability to lead scientific projects and collaborate across cross-functional teams.

Preferred Skills

• Experience with biologics manufacturing, cell culture, fermentation, purification, or aseptic processing.
• Understanding of chemically defined media and feed systems and their impact on cell performance and product quality.
• Experience characterizing impurities and trace-level contaminants affecting process performance or product quality.
• Expertise in chromatographic and mass spectrometry techniques, including HPLC, UPLC, UHPLC, LC-MS, LC-MS/MS, GC-MS, ICP-MS, and related methodologies.
• Experience with cell-based assays, amino acid/vitamin analysis, particle characterization, microscopy, thermal analysis, or other advanced characterization techniques.
• Experience using analytical data to support supplier qualification, raw material risk assessments, and supply chain optimization.
• Familiarity with PAT, automation, digital tools, and data analytics.
• Experience working with suppliers and external laboratories to improve raw material quality and consistency.

Key Competencies

Adaptability, Adaptability, Analytical Thinking, Bioprocess Understanding, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Cross-Functional Collaboration, Materials Characterization, Risk Analysis, Risk Assessments, Risk Control Assessment, Stakeholder Communications, Stakeholder Engagement

Required Skills:

Analytical Chemistry, Analytical Tools, Biologics, Characterization Techniques, Cross-Functional Project Management, Data Analysis Tools, Liquid Chromatography (LC), Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmaceutical Sciences, Raw Material Analysis, Raw Material Sourcing, Regulatory Compliance, Technical Transfer, Technology Transfer

Preferred Skills:

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US and Puerto Rico Residents Only:

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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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The salary range for this role is

$117,000.00 - $184,200.00

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

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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:

09/29/2026

*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.