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We are searching for the best talent for Vice President, Analytical Development, Proteins.
Position Summary
* Responsible for leading Protein Analytical Development covering 4 complex protein derived therapeutic formats (Antibodies, Multi-specifics, Antibody-Drug Conjugates, and Radio Pharmaceuticals) as well as emerging novel protein derived formats in 50+ R&D programs in development.
* Responsible for supporting 11 commercial products globally across all JJIM sites which generate >$40B in revenue through collaboration with IMSC
* Lead end-to-end Analytical Development organization of ~350 FTE + 300 contractors across 5 global sites in US, Ireland, Netherlands, Switzerland, and China to enable IND approvals for clinical trials and BLA/MAA approval for commercial licensure globally.
* Collaborates internally with TA, TD, PSTS, IMSC, RA, Quality, and externally with global health authorities to drive development strategy and execution.
* Responsible for shaping external regulatory strategy through direct projects with health authorities, engagement on global regulations, industry forums, participation at meetings, and publications & presentations. This is a critical activity as global filings occur in >100 countries.
* Shape the Quality strategy for Protein Derived Therapeutics to implement phase-appropriate quality across all JJIM development and manufacturing sites.
* Drives scientific as well as digital strategy & innovation to deliver on an increasingly larger and complex protein portfolio with increasing speed and operation efficiency. Drive change management and shape a winning culture.
Major Duties & Responsibilities
* 60% -- Analytical Development of New Molecule Entities (>50 assets) including management of ~350 FTE + ~300 contractors in 5 countries
* 20% -- Global Commercial Product Support (10 products). Provide support in >100 countries
* 20% -- Global Regulatory filings for product licensure and Shaping external Regulatory environment
* 10% -- Global Phase Appropriate Quality for Protein Derived Therapeutics
Key Working Relationships:
* Internal -- All the functions within TA, DPDS, IMSC, RA, and QA across all of the Janssen sites globally
* External -- Global Health authorities, Contractors, CMO, and CROs
Education and Requirements
* PhD Required in Biochemistry or other life sciences
* More than 20 years experience in Biopharmaceutical Development with demonstrated success in developing new products and bringing to market across multiple protein derived formats including but not limited to monoclonal antibodies, multi-specifics, antibody drug conjugates, radio pharmaceuticals, etc.
* 15+ years people management experience
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 and 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, please email the Employee Health Support Center (ra-) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Decision Making, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Medical Communications, Molecular Diagnostics, Operational Excellence, Pharmacovigilance, Productivity Planning, Product Strategies, Scientific Research, Stakeholder Management, Strategic Thinking Similar jobs