Principal Scientist, Early DCT Lead

Merck; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement benefits

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist to lead Early-Stage Development and Commercialization Teams, directing integrated CMC strategies for pipeline biologics from candidate selection through early clinical development.

The role emphasizes cross-functional leadership across Drug Substance, Drug Product, Analytical Development, Regulatory, and Quality, with a strong emphasis on risk management, data-driven decision making, and readiness for regulatory filing and launch.

Qualifications

• Ph.D. with 8+ years in biopharmaceutical industry; or
• M.S. with 10+ years in biopharma; or
• B.S. with 14+ years in biopharma.

Responsibilities

• Lead Early-Stage Development and Commercialization Team (DCT) with accountable integrated CMC strategy.
• Drive cross-functional alignment across Drug Substance, Drug Product, Analytical Development, Regulatory, QA, and Supply.
• Frame program decisions, manage risks, escalate to leadership as needed.
• Mentor scientists to meet milestones and regulatory documentation.
• Support regulatory submissions and launch readiness activities.

Skills

CMC Leadership

Cross-functional

Regulatory Filing

Biologics

DOE

Technology Transfer

Project Management

Mentoring

Biopharma

Education

Ph.D. in Chemical/Biomedical Engineering/Pharmaceuticals

M.S. in related discipline

B.S. in related discipline

Job description

Job Description

The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms, including injections, implants, inhaled and ocular products, for small, intermediate and large molecules from preclinical toxicology studies through commercialization. Our development teams ensure robust formulation, primary packaging/device, process and manufacturing strategies through deep scientific understanding and characterization, enabling scalable development plans without compromising stability, safety, efficacy or delivery. During development, we leverage smart experimental design, cutting-edge analytical tools and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.

Job Description

The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms, including injections, implants, inhaled and ocular products, for small, intermediate and large molecules from preclinical toxicology studies through commercialization. Our development teams ensure robust formulation, primary packaging/device, process and manufacturing strategies through deep scientific understanding and characterization, enabling scalable development plans without compromising stability, safety, efficacy or delivery. During development, we leverage smart experimental design, cutting-edge analytical tools and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.

Our team is seeking an accomplished, highly collaborative scientific and matrix leader for a Principal Scientist (R5) – Development and Commercialization Team (DCT) Leader position at our research facility in Rahway, New Jersey. 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. The candidate is expected to have biologics product development experience and will continue to support relevant drug product activities, combined with broad working-knowledge of end-to-end CMC disciples and a proven ability to lead matrixed teams with an enterprise, "robustness at launch" mindset. 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):

• 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).
• 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.
• 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.
• Frame key program decisions, clarify cross-functional trade-offs, identify and mitigate risks, and ensure timely escalation to functional leadership, governance, regulatory, quality, manufacturing, supply, or commercial stakeholders when needed.
• 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.

Drug Product Technical And Strategic Leadership

• Provide drug product leadership and support for relevant early-stage activities, including composition selection, scalable process development, primary packaging/device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support.
• Mentor and guide scientists or team members, as appropriate, to support completion of key milestones and required laboratory or regulatory documentation.
• Contribute to ideating, leading, and championing organizational strategic and innovation objectives aligned with broader organizational goals.
• Demonstrate accountability, adaptability, sound judgment, inclusive leadership behaviors, and strong communication and interpersonal skills.

Minimum Education Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, or a related discipline, with at least 8 years of relevant biopharmaceutical industry experience; or
• M.S. in a related discipline, with at least 10 years of relevant biopharmaceutical industry experience; or
• B.S. in a related discipline, with at least 14 years of relevant biopharmaceutical industry experience.

Required Experience And Skills

• Experience serving as a Development and Commercialization Team lead, or in an equivalent integrated program leadership role, with demonstrated ability to lead cross-functional development or commercialization teams and drive alignment across functions, divisions, and partner organizations.
• Strong understanding of integrated CMC development and key interfaces across drug substance, drug product, analytical, regulatory, quality, packaging/device, manufacturing, and supply functions.
• Ability to identify program risks, clarify cross-functional trade-offs, develop practical mitigation or contingency plans, and support data- and judgment-based decision-making.
• Experience supporting development milestones, governance discussions, technical reviews, regulatory submissions, health authority response planning, launch preparedness, or commercialization readiness activities.
• Strong collaboration, influencing, facilitation, and communication skills, with the ability to lead effectively in a matrixed environment without direct authority.
• Ability to translate complex cross-functional information into clear, decision-oriented communications for diverse audiences.
• Proven accountability for follow-through, issue resolution, and delivery of program objectives while fostering an inclusive, transparent, and respectful team culture.
• Strong track record in biologics product development, regulatory filing, drug delivery, and complex formulation and process development, reflected through industry experience and, where applicable, external publications or patents.
• Experience with biologics pipeline programs and modalities such as mAbs, ADCs, fusion proteins, doublet or triplet co-formulations,
• Strong familiarity with biologic analytical methods, drug product specifications, and drug substance downstream formulation considerations.
• Demonstrated interest and track record in mentoring junior scientists toward time-bound goals.
• Scientific leadership in biologics product development and demonstrated leadership behaviors.
• Preferred experience leading or significantly contributing to CMC teams through late-stage development, regulatory filing, approval, technology transfer, validation readiness, or launch activities.

Required Skills

Biologics, Biopharmaceuticals, Biotechnology, Cell Culture Process Development, Cell Line Development, CMC Development, Combination Products, Cross-Functional Project Management, Data Analysis, Design of Experiments (DOE), Drug Delivery, Early Phase Clinical Trials, Finite Element Analysis (FEA), Leadership Mentoring, Matrix Leadership, Next Generation Science Standards, Pharmaceutical Process Development, Pharmaceutical Sciences, Pharmaceutics, Pharmacodynamics, Pharmacokinetics, Preclinical Research, Quality by Design, Regulatory Filings, Technology Transfer

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.

Requirements

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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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.

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:

R421067

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

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

$173,200.00 - $272,600.00

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.