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Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Biotherapeutics R&D
Job Category:
People Leader
All Job Posting Locations:
Malvern Pennsylvania United States of America
Job Description:
Johnson & Johnson -- 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 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 () 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
The anticipated base pay range for this position is :
$218000.00 - $401350.00
Additional Description for Pay Transparency:
ubject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys long-term incentive program.
Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:
Vacation 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay including Floating Holidays 13 days per calendar year
Work Personal and Family Time - up to 40 hours per calendar year
Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year
For additional general information on Company benefits please go to: - Experience:
Exec