Vice President, Analytical Development -- Proteins
About The Position
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 https://www.jnj.com/innovative-medicine 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.
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
Nice To Haves
- 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
Responsibilities
- Analytical Development of New Molecule Entities (>50 assets) including management of ~350 FTE + ~300 contractors in 5 countries
- Global Commercial Product Support (10 products). Provide support in >100 countries
- Global Regulatory filings for product licensure and Shaping external Regulatory environment
- Global Phase Appropriate Quality for Protein Derived Therapeutics
Benefits
- employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company's long-term incentive program.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
