Lead process validation, design, development, and optimization of aseptic pharmaceutical manufacturing processes, ensuring compliance with cGMP and global regulatory expectations.
Compensation
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Responsibilities
Lead process validation (PPQ) and ongoing process verification activities for sterile drug products
Ensure product and process-related technical services align with regulatory and internal standards
Lead design, development, and optimization of aseptic manufacturing processes for robustness, scalability, and efficiency
Define critical process parameters (CPPs) and critical quality attributes (CQAs) for manufacturing processes
Initiate and lead process risk assessments (FMEA, Ishikawa, etc.) and implement risk mitigation strategies
Requirements
Bachelor’s or Master’s degree in Pharmaceutical Science, Chemical/Biochemical Engineering, or related field
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.
Complete Technology Transfer activities by performing manufacturing process development for injectable products and transferring them to commercial lines. Using experimental design, establish formulation processes, product pathways, and select components for successful scale-up.
Responsibilities
Complete Technology Transfer activities by performing manufacturing process development for injectable products and transferring them to commercial lines.
Using experimental design, establish formulation processes, product pathways, and select components for successful scale-up.
Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, and summaries) with minimal supervision, provide scientific justification as needed, and communicate project status.
Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
Lead technical/scientific process, product, and project activities to implement strategies and solutions.
Requirements
Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related physical science
Master’s degree in a related scientific discipline
PhD in a related scientific discipline
Nice to have: CMO/CDMO or pharmaceutical product development experience
Provide technical leadership for the development and manufacturing of precursors and active pharmaceutical ingredients (APIs) through external Contract Manufacturing Organizations (CMOs).
Locations (3)
Oslo, Oslo County, Norway
Eindhoven, North Brabant, Netherlands
Potards, Hertfordshire, United Kingdom
Responsibilities
Lead the development and manufacturing of APIs, precursors, and key materials at external CMOs from early development through commercialization.
Act as the primary technical interface between internal project teams, CMOs, key suppliers, and other external development and manufacturing partners.
Define development strategies, deliverables, timelines, risks, and priorities, and oversee process development, optimization, scale-up, technology transfer, and GMP manufacturing.
Lead technology transfer and process development for injectable products, supporting scale-up, validation, and manufacturing operations in a sterile environment.
Responsibilities
Complete technology transfer activities for injectable products
Establish formulation processes and product pathways
Support client calls and prepare documentation
Lead technical/scientific process and project activities
Drive creation of processes, single-use systems, and equipment designs
Requirements
Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related physical science
Master’s degree in a related scientific discipline
Contribute to assessing selecting, qualifying, and onboarding CMOs and key suppliers based on technical capabilities, capacity, quality, cost, timelines, and risk, and monitor ongoing performance.
Lead technical, quality, and manufacturing challenges, including deviations, investigations, change controls, and impurity-related issues.
Requirements
PhD in Organic Chemistry
MSc in Organic Chemistry
MSc in Pharmaceutical Chemistry
MSc in Chemical Engineering
MSc in related scientific or engineering discipline
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