Lead strategy and execution of biologics drug substance programs at the Rahway, New Jersey site.
Compensation
$173,200.00 - $272,600.00
Responsibilities
Direct strategy and execution of biologics drug substance programs
Lead cross‑functional CMC teams
Coordinate strategy and execution across Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, pilot and commercial manufacturing, and external partners
Identify program risks and develop data‑driven contingencies
Maintain delivery rigor through structured meeting cadences and risk registers
Requirements
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, or a related discipline
Lead integrated CMC program for early-stage biologics development and commercialization
Compensation
The salary range for the primary location of this role is: $173,200.00 - $272,600.00
Responsibilities
Lead integrated CMC program for pipeline biologics
Drive strategic and operational alignment across CMC interfaces
Mentor and guide scientists
Support development milestones and regulatory filings
Requirements
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, or a related discipline
The role seeks a highly collaborative scientific and matrix leader to lead the Development and Commercialization Team (DCT) for pipeline biologics, moving from candidate selection through early clinical development and First-in-Human (FIH) milestones.
Compensation
$173,200.00 - $272,600.00
Responsibilities
Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, holding accountability for integrated CMC development strategy, milestone readiness, and cross-functional alignment.
Lead and operationalize matrixed CMC project teams; establish transparent team structures, functional working groups, clear decision rights, milestone-driven timelines, and escalation pathways.
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.
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.
Requirements
Associate Principal Scientist, Upstream Process Development
The Associate Principal Scientist will contribute to CMC development of the company's pipeline, leading the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites.
Compensation
$142,000 - $224,100
Responsibilities
Participates in andor leads upstream process development of first-in-human and commercial processes by efficiently developing high yield, robust, and scalable cell culture processes.
Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
Requirements
Ph.D. with 4+ years' experience
Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field
Seeking an accomplished scientific leader to direct the strategy and execution of biologics drug substance programs, combining cross-functional CMC program leadership with deep expertise in cell line, upstream, and downstream process development to advance biologics through First-in-Human (FIH) milestones.
Compensation
$173,000 - $272,600
Responsibilities
Lead assigned early-stage Development and Commercialization Teams (DCTs), with accountability for integrated CMC strategy, milestone readiness, and advancement through governance decisions.
Establish and lead matrixed CMC teams with clear structures, working groups, decision rights, timelines, escalation paths, and functional accountability.
Coordinate strategy and execution across Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, pilot and commercial manufacturing, and external partners.
Identify program risks, evaluate cross-functional trade-offs, develop data-driven contingencies, and provide clear recommendations to senior leaders and governance bodies.
Define phase-appropriate drug substance strategies covering cell line development, upstream and downstream process development, scale-up, technology transfer, and clinical supply.
Principal Scientist, Early DCT LeadMerck · Rahway, US