Johnson & Johnson Innovative Medicine · 4 hours ago
Sr Principal Scientist, Process Develop
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to building a world where complex diseases are prevented and treated. The Senior Principal Scientist will serve as a scientific individual contributor and subject-matter expert in Drug Product process development, guiding teams on critical process development and regulatory strategies for biologics assets.
Pharmaceuticals
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
This is an individual contributor role
Qualification
Required
Minimum of a Bachelor's degree is 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)
Preferred
PhD in a technical field (e.g. Chemical Engineering, Pharmaceutical Science, Biochemistry) is highly 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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
Company data provided by crunchbase