Johnson & Johnson · 18 hours ago
Sr Principal Scientist, Process Develop
Malvern, Pennsylvania, United States of America
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to developing treatments and pioneering solutions for complex diseases. The Senior Principal Scientist in Global Process Development will serve as a scientific contributor and expert in drug product processes, guiding teams on development, scale-up, and technology transfer while ensuring compliance with regulatory standards.
Hospital & Health Care
Responsibilities
Working independently across GPD, DPDD, TDS, IMSC, and other groups to shape and influence the drug product (DP) process landscape and build a portfolio of value-generating DP process opportunities
Coaching and mentoring junior scientists on DP process topics
Establishing and maintaining internal capabilities for biologics DP process development, scale-up, and technology transfer consistent with industry standards and best practices
Serving as strategist, author, contributor, reviewer, and approver of DP process sections in health authority submissions for biologics
Partnering with Supply Chain, manufacturing site leads, Quality, Regulatory, and GPD to ensure smooth transfer and introduction of manufacturing processes into production sites in compliance with regulatory requirements
Designing experiments to identify critical process parameters and proposing detailed control strategies aligned with regulatory expectations and sound business practices
Interpreting scientific data and conducting critical reviews of global process development study reports
Leading initiatives for best product/process readiness at launch (right-first-time) and for harmonization and optimization of process development and technology transfer
Participating in issue-resolution teams by engaging in scientific discussions and shaping strategies that inform critical development decisions
Contributing to DPDD’s success and growth through active participation in internal and external committees and close collaboration with scientists in Formulation Development, Drug Delivery Systems, Analytical Development, drug substance (API) development, and CMC project leaders across the US, EU, and China
Qualification
Required
Minimum of 8 years of experience developing and commercializing parenteral, biologic drug product processes
Technical expert on current manufacturing processes and equipment and engineering scaling principles with the ability to apply knowledge to technology transfer and process optimization, aligned with HA-guidelines and GMP regulations
Prior experience in scientific data evaluation, statistical analysis, experimental design and execution, including ideally at-scale, and scientific writing/reviewing regulatory documents and technical reports across multiple complex programs
Strong written and verbal communication skills, the ability to negotiate and influence decision-making processes, think and manage issues to resolution, and contribute to study teams and scientific discussions
Proven personal leadership with a track record of influencing junior scientists, peers, and senior leaders; proactive and adaptable, with a focus on urgency for patients; excels at collaboration and building inclusive team relationships
Ability to travel to support development and manufacturing projects at internal or external sites in US and EU (up to 10% travel – project dependent)
Minimum of a Bachelor's degree is required
Preferred
Demonstrated expertise in LCPV/criticality/control strategy development
Track record of conceptualizing and leading innovation projects
Experience with setting regulatory strategy and responding to written Health Authority questions
PhD in a technical field (e.g. Chemical Engineering, Pharmaceutical Science, Biochemistry) is highly preferred
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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