SR DISTINGUISHED SCIENTIST, CMC AND INNOVATION LEADER

Johnson & Johnson is recruiting for a Senior Distinguished Scientist, CMC and Innovation Leader role based in Malvern, PA with the option of being remote.
This individual will lead innovation strategy as a matrix leader across Therapeutic Development & Supply (TDS) and will lead one or more radioligand therapy CMC programs in TDS as a CMC Leader.
As a matrix leader, will support and influence all aspects of the E2E compound development from pre-NME to post-BLA/MAA approval, including Life Cycle Management, with oversight of the development strategy and associated budgets and timelines for their program(s).
In addition, the role will oversee CMC regulatory submissions and responses to deliver clinical and launch drug supplies in accordance with development plans, provide leadership and facilitate strategy development and implementation.
This role is an independent contributor with no direct reports.
The role will provide guidance on a broad range of topics in support of innovation, new business and cross-functional initiatives in support of the TDS and DPDS strategic vision.
This includes leadership and oversight of innovation within the TDS functions to enhance efficiencies in development through commercialization.
The role will build strategic partnerships and alliances to align with portfolio growth and innovation strategy in collaboration with other TDS operational groups and Innovative Medicine Supply Chain.
The role will work cross-functionally with other leaders within TDS, DPDS, and partner across the Therapeutic Areas, Global Clinical Operations, and IMSC for the timely and efficient delivery on projects.
The position reports to VP, Global Head of CMC Portfolio Strategy and is a fulltime member of the CMC Portfolio Strategy Leadership Team.
Key Responsibilities.
Develop and implement E2E strategies for delivery of the radioligand portfolio.
Serve as a CMC Leader of one or more radioligand programs.
Provide strategic and operational leadership to CMC team and manage PD OOPs budget in support of the portfolio.
Lead innovation across TDS as a matrix leader.
Negotiates and solicits acceptance of innovative ideas, approaches, concepts through programmatic leadership as an internal expert with a direct impact on IMRD/IMSC portfolio and/or business objectives.
Acts as a scientific mentor for project teams and individuals.
Independently identifies and analyzes high-impact, complex and cross-functional challenges and gaps across the radioligand portfolio.
Significantly improves, changes, or develops new business/work processes to share knowledge, build intellectual capital, and promote innovation in the radioligand portfolio.
Influences across disciplines with senior leaders and external colleagues/ partners to drive and align strategic and operational activities across regions, therapeutic/functional areas.
Collaborate with Business Development for Due Diligence activities, and clinical, regulatory, Innovative Medicine Supply Chain, and TA teams to deliver clinical and commercial drug supplies in accordance with development plans.
Full time member of the CMC Portfolio Strategy Leadership Team collaborating with LT peers on shaping the strategy of the organization to deliver the portfolio.
Qualifications Qualifications Education.
PhD or Equivalent experience in relevant area.
Preferred areas of study.
Pharmaceutical Sciences, Chemical Engineering or equivalent.
Experience and Skills.
15+ years related experience and 5 years direct or indirect people management experience.
Significant expertise in mAbs, multispecifics, radioconjugates and antibody conjugate development through demonstrated and positive track record in multiple R&D disciplines.
Includes both early stage, late stage, and lifecycle management of portfolio and manufacturing process experience but not limited to the following.
mAbs, bispecifcs, trispecfics, radioligand therapy IND/IMPD, BLA/MAA, and sBLA/Type II variation review/approval experience.
Demonstrated matrix team leadership experience with a proven track record of indirectly leading complex scientific team(s) and core technical leaders and managers across functions/regions for an extended period.
Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the team.
Key Working Relationships.
INTERNAL.
Serves as a key technical point of contact between CMC Portfolio Management and partner functions in IMSC, Quality, Regulatory, etc.
with regards to manufacturing processes and process design.
Works with other core functions including API-Proteins, AD, and DPD to improve development at interfaces.
Ensures new process and training are provided to staff to understand new technologies impacting the portfolio.
EXTERNAL.
Serves as a strategic point of contact between Radioligand Portfolio and development partners.
Represents the group in external forums (e.
.
Nimbl) The anticipated base pay range for this position is to .
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
· Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be 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.
Employees are eligible for the following time off benefits.
- Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
https://www.
areers.
nj.
om/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market." Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.