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Johnson & Johnson Innovative Medicine · 1 day ago

Vice President, Analytical Development -- Proteins

Malvern, PA

Full-time

Onsite

Director/Executive

$218K/yr - $401K/yr

20+ years exp

Johnson & Johnson is a leader in healthcare innovation, focused on developing smarter and less invasive treatments. The Vice President of Analytical Development for Proteins will lead a global team in the development of complex protein-derived therapeutics and ensure compliance with regulatory standards while driving innovation in the field.

Pharmaceuticals

Responsibilities

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

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

Qualification

Biopharmaceutical DevelopmentProtein Analytical DevelopmentRegulatory StrategyLeadershipBiochemistryClinical ResearchDrug Discovery DevelopmentOperational ExcellenceAgile Decision MakingDeveloping OthersInclusive LeadershipMedical CommunicationsMolecular DiagnosticsProductivity PlanningProduct StrategiesScientific ResearchStakeholder ManagementStrategic Thinking

Required

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

Preferred

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

Productivity Planning

Product Strategies

Scientific Research

Stakeholder Management

Strategic Thinking

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 period

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year