Principal Scientist, Global Process Development, Drug Product Development and Delivery

Johnson & Johnson•Malvern, PA

1d•Hybrid

About The Position

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.

Requirements

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.
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.
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.

Responsibilities

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.
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.
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.
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.
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.