The Process Automation Engineer Specialist provides automation system support and technical expertise to enable the reliable and compliant supply of quality vaccine products, involving problem resolution, process control implementation, and troubleshooting.
Compensation
The salary range for the primary location of this role is: $87,300.00 - $137,400.00
Responsibilities
Problem resolution, implementation of process control and data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental requirements.
Work closely with Manufacturing, Quality, and Engineering organizations to support automated systems within GMP operations.
Comply with global policies, procedures, guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
Serve as the technical owner for automation system components supporting manufacturing processes, including direct shop-floor support.
Design, implement, test, and close change controls associated with automation-related corrective actions and continuous improvement initiatives.
Providing automation system support and expertise to enable the Manufacturing Division in the reliable and compliant supply of quality vaccine products.
Compensation
The salary range for the primary location of this role is: $71,900.00 - $113,200.00
Responsibilities
Problem resolution
implementation of process control
data collection techniques
troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations
Support a broad spectrum of automated systems within GMP Manufacturing Operations
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.
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.
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