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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
 

Learn more at https://www.jnj.com/innovative-medicine   
 

We are searching for the best talent for a Principal Scientist, Global Process Development, Drug Product Development and Delivery to be located in Malvern, PA.
 

Purpose: We are seeking an authority and highly motivated Global Principal Process Scientist to provide global technical leadership for the development, scale-up, transfer, validation, and commercialization of Antibody Drug Conjugate (ADC) drug product manufacturing processes. This individual will support both early-stage clinical development and late-stage/commercial programs, ensuring robust, scalable, conformant, and patient-centric manufacturing processes.
 

The successful candidate will bring deep expertise in sterile drug product process development, including formulation, compounding/filling, lyophilization, aseptic manufacturing, container closure, process characterization, and control strategy development, with significant bioconjugate (ADC) experience.
 

This role partners closely with Formulation, Manufacturing Science & Technology (MSAT), Quality, Regulatory Affairs, Supply Chain, internal manufacturing sites, and external manufacturing partners to advance phase-appropriate development strategies and commercialization roadmaps for bioconjugate (ADC) assets across the product lifecycle.
 

You will be responsible for:

Technical Leadership

• Serving as the global technical lead, establishing scalable platforms, technical standards, Quality by Design practices, risk assessments, and process understanding strategies.
   
• Developing and implement phase-appropriate strategies for early-stage clinical and late-stage bioconjugate (ADC) programs.
   

Process Development & Lifecycle Management

• Leading development of robust manufacturing processes from preclinical through clinical and Process Performance Qualification (PPQ) readiness stages, including process characterization studies, Critical Process Parameter (CPP)/Critical Quality Attribute (CQA) definition, control strategies, process validation plans, and manufacturing capability assessments.
   
• Supporting lifecycle management, continuous improvement, and post-approval change activities to maintain conformant and reliable drug processes.
   

Technology Transfer & Manufacturing Support

• Leading technology transfer activities across development, pilot, clinical, and commercial manufacturing sites, providing technical support for global manufacturing facilities and Contract Development & Manufacturing Organizations (CDMOs).
   
• Resolving sophisticated process and manufacturing issues and support investigations, deviation assessments, CAPAs, and change controls.
   

Regulatory & Compliance Support

• Authoring and reviewing Chemical, Manufacturing, and Controls (CMC) sections of regulatory submissions, support global regulatory interactions, and provide technical justification for development, validation, and control strategy decisions.
   
• Aligning all product innovation, manufacturing and commercialization strategies with cGMP, ICH, FDA, EMA, and other applicable regulatory expectations.
   

Multi-Functional Leadership

• Collaborating across Development, MSAT, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external partners to deliver project breakthroughs and regulatory results.
   
• Mentoring junior scientists and engineers and influence strategic direction and portfolio decisions through technical expertise.
   

Qualifications/Requirements

Education:

• A minimum of a Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field with 8+ years of relevant biopharmaceutical experience, including 8+ years of sterile drug product process development and manufacturing experience; OR a Master's degree with 6+ years; OR a PhD with 4+ years is required.
   

Experience and Skills:

Technical Expertise

• Proven expertise in bioconjugate (ADC) lifecycle, spanning advanced aseptic processing, sterile manufacturing, process scale-up and technology transfer, process characterization and validation, risk management, control strategy, and statistical process/data analysis is required.
   

Regulatory Knowledge

• Strong understanding of FDA, EMA, PMDA, and Health Canada expectations; ICH guidelines Q8, Q9, Q10, Q11, and Q12; process validation lifecycle principles; commercial readiness requirements; and global GMP regulations is preferred.
   

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
 

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
 

#LI-Hybrid

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research