Johnson & Johnson Innovative Medicine · 8 hours ago
Senior Principal Scientist, Global Process Development, Drug Product Development & Delivery
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expJohnson & Johnson Innovative Medicine is focused on healthcare innovation to deliver breakthroughs for humanity. They are seeking a Senior Principal Scientist to provide guidance on process development and technology transfer for biologics drug product manufacturing.
Pharmaceuticals
Responsibilities
Establish and maintain, to industry standards and best-practices, internal capabilities for biologics drug product process development, scale-up, and technology transfer
Lead process development, scale-up, technology transfer, process validation, and health authority submissions for biologics drug products
Partner with MSAT, manufacturing site leads, quality, regulatory, and other functions for flawless introduction of manufacturing processes into production sites in accordance with pertinent regulatory guidelines
Design of experiments supporting rigorous control strategies and aligned with regulatory expectations
Scientific data interpretation and critical report review of global process development studies
Lead best product and process at launch, right first time, and other process development and technology transfer harmonization/optimization initiatives
Participate in issue-resolution teams through active engagement in scientific discussions and the shaping of strategies designed to support and inform critical development decisions
Contribute to the success and growth of DPDD through active participation in internal and external committees / working groups and closely interact with scientists in other functional areas including formulation development, drug delivery systems, analytical development, drug substance development, and CMC project leaders in the US, EU, and China
Management of direct reports
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, budget management across multiple complex programs, and scientific writing
Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes, think and manage issues to resolution, and contribute to study teams and scientific discussions
Personal leadership skills, a pro-active and flexible attitude, sense of urgency and excellent collaboration and inclusive team relationships skills
Ability to travel to support development and manufacturing activities at CMOs, CRLs, and internal sites in US and EU (up to 15% travel – project dependent)
Preferred
PhD in a technical field (e.g. Chemical Engineering, Pharmaceutical Science, Biochemistry) is highly preferred
Minimum of 4 years of experience developing and commercializing parenteral, bioconjugate drug product processes (liquid and lyophilized)
Direct experience developing and commercializing drug product processes for antibody-radionucleotide-conjugates
Experience with written regulatory interactions in support of drug development
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
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