Principal Scientist, Early DCT Lead

Job Description

Role Description:

This high-visibility role combines integrated cross-functional program leadership with deep subject-matter expertise (SME) in biologics analytical development. As an Early-Stage DCT Leader, you will provide strategic, technical, and operational direction for integrated CMC teams, advancing a portfolio of pipeline biologics from candidate selection through early clinical development and First-in-Human (FIH) milestones, while laying the groundwork for commercialization. Simultaneously, you will serve as an analytical SME within the department, responsible for guiding focused method development, driving phase-appropriate integrated analytical control strategies, assessing Critical Quality Attributes (CQAs) for each molecule, and championing robust characterization to enable swift, high-quality pipeline progression.

The ideal candidate bridges enterprise matrix leadership with rigorous technical acumen, demonstrating a proven track record of driving cross-functional alignment, managing program risk, and championing scientific excellence.

Primary Responsibilities:

Integrated CMC Program Leadership (DCT Lead):

Program Accountability: Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, holding accountability for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progression across formal governance gates (e.g., Development & Commercialization Review Committee [DCRC] milestones).

Operating Model Execution: Lead and operationalize matrixed CMC project teams; establish transparent team structures, functional working groups, clear decision rights, milestone-driven timelines, escalation pathways, and single-point accountability across functions.

Cross-Functional Interface Alignment: Drive strategic and operational alignment across key CMC interfaces, including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant/Commercial Manufacturing, and external partner organizations.

Risk Management & Governance: Proactively identify program vulnerabilities, evaluate cross-functional trade-offs, formulate data-driven contingency plans, and communicate recommendations with clarity to senior leadership, governance bodies, and key stakeholders.

Disciplined Execution & Cadence: Drive project rigor through structured meeting cadences, decision logs, action tracking, transparent risk registers, and timely cross-functional communication across working groups and governance bodies.

Analytical Subject Matter Expertise & Strategy:

Analytical Control Strategy: Define and champion phase-appropriate analytical control strategies, product characterization workflows, and specification-setting rationales for early-phase biological modalities (e.g., mAbs, multispecifics, fusion proteins, novel biotherapeutics).

CQA & Degradation Profiling: Oversee the evaluation of Critical Quality Attributes (CQAs), forced degradation pathways, structure-function relationships, and in-use stability/compatibility studies to establish clinical phase-appropriate comparability and shelf-life.

Regulatory Authoring & Technical Reviews: Guide and contribute to the technical authoring, review, and approval of analytical sections of global regulatory filings (IND/IMPD), briefing books, and responses to health authority queries. Lead or actively participate in Analytical Technical Reviews (ATRs).

Technical Problem Solving: Leverage advanced knowledge of physicochemical, biophysical, and functional characterization techniques to troubleshoot complex analytical and formulation/downstream processing challenges.

People, Mentorship & Organizational Leadership:

Talent Development: Mentor and coach early-career scientists, functional leads, and technical project members, cultivating cross-functional acumen, scientific depth, and project execution capabilities.

Continuous Improvement: Champion departmental and cross-functional initiatives aimed at accelerating FIH cycle times, streamlining CMC governance handoffs, and adopting innovative analytical or digital/informatics workflows.

Enterprise Culture: Model inclusive leadership, psychological safety, transparent communication, and operational excellence across matrix teams and departmental functions.

Qualifications & Requirements:

Minimum Education Requirements:

Ph.D. in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, Biophysics, or a related scientific discipline with a minimum of 8 years of relevant biopharmaceutical industry experience; OR

M.S. in a related scientific discipline with a minimum of 10 years of relevant biopharmaceutical industry experience; OR

B.S. in a related scientific discipline with a minimum of 14 years of relevant biopharmaceutical industry experience.

Required Experience and Skills:

Integrated CMC & Matrix Program Leadership: Demonstrated experience serving as a Development and Commercialization Team (DCT) lead or in an equivalent cross-functional program leadership role, driving alignment and execution across drug substance, drug product, analytical, regulatory, quality, device/packaging, manufacturing, and supply chain functions.

Biologics Analytical Development Depth: Proven track record in biologics analytical development, including method design, qualification/validation, method transfer, phase-appropriate specification setting, and elucidation of Critical Quality Attributes (CQAs) and degradation pathways, as demonstrated by active engagement with external consortia, scientific conferences, and/or peer-reviewed publications showcasing leadership in analytical sciences and biologics development.

Advanced Characterization Acumen: Subject-matter expertise with modern biophysical and biochemical analytical platforms, including separation sciences (U/HPLC, SEC, IEX, HIC, RP, CE-SDS, cIEF), mass spectrometry (intact mass, peptide mapping, PTMs), biophysical techniques (CD, DSC, DLS, AUC, sub-visible particle analysis), functional/potency assays (ELISA, SPR, cell-based assays), and/or process-related residuals.

Regulatory Dossier Strategy & Authoring: Direct experience authoring, reviewing, and defending analytical and CMC sections of regulatory filings (IND, IMPD, or equivalent), health authority briefing packages, and information requests.

Risk Management & Data-Driven Decision-Making: Proven ability to identify program risks, clarify complex cross-functional trade-offs, establish contingency pathways, and guide data- and judgment-based decisions.

Matrix Communication & Stakeholder Influencing: Exceptional collaboration, facilitation, and influencing skills to navigate matrix environments without direct authority; ability to synthesize complex technical data into concise, decision-oriented communications for governance and executive leadership.

Delivery & People Leadership: Demonstrated accountability for program delivery and milestone execution, paired with a proven commitment to mentoring junior scientists and fostering an inclusive, transparent, and high-trust team culture.

Preferred Experience and Skills:

Experience with accelerated development paradigms, platform strategies, or transition from early-stage to late-stage commercialization readiness.

Experience with complex biological modalities (e.g., bispecific/multispecific antibodies, antibody-drug conjugates [ADCs], or fusion proteins).

Required Skills:

Analytical Method Development, Analytical Method Development, Analytical Thinking, Assay Development, Bioanalytical Analysis, Biopharmaceuticals, Biotechnology, Chromatographic Techniques, Clinical Judgment, Commercialization, Cross-Functional Project Management, Cross-Functional Teamwork, Dosage Forms, Early Phase Clinical Trials, Ethical Compliance, Executive Leadership, Inclusive Leadership, Influencing Skills, Liquid Chromatography (LC), Matrix Leadership, Matrix Management, Mentoring Staff, Method Validation, Operating Models, Organizational Leadership {+ 8 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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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$156,900.00 - $247,000.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

11/21/2026 *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:R420966