Sr Director, Antibody Conjugates, CMC Portfolio ...

Johnson & Johnson is recruiting for a Senior Director, Antibody Conjugates, CMC Portfolio Management located in Malvern, PA. This leadership position will lead the Antibody Conjugate CMC leaders while also serving as a CMC Leader in TDS supporting and influencing 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 the antibody conjugate portfolio. 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 Global People Leader 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 advice on early development through commercialization, plans for conjugated protein portfolio assets, and oversight of Business Development due diligence activities in this area. 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 Management and Strategy Leadership Team. Key Responsibilities: + Develop and implement E2E strategies for delivery of the Antibody Conjugate portfolio. Lead the CMC Portfolio Management team accountable for the Antibody Conjugate portfolio. + Provide strategic and operational leadership to CMCL and manage PD OOPs budget in support of the portfolio. + Attract and develop high performing diverse talent through development of functional CMCL, smart talent acquisition and strong training and development approaches. + Provide scientific direction, strategy, and mentorship to scientific leaders for products in development. Ensures staff are properly trained for their role as CMCL. + 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 antibody conjugate portfolio. + Significantly improves, changes, or develops new business/work processes to share knowledge, build intellectual capital, and promote innovation in bio-conjugate portfolio. + Negotiates and solicits acceptance of new ideas, approaches, concepts through programmatic leadership and acts as an internal expert with a direct impact on IMRD/IMSC portfolio and/or business objectives; Owns portfolio escalations and stakeholder management. 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 area of study: Pharmaceutical Sciences, Chemical Engineering, or equivalent. Experience and Skills: Required: + 5 years of direct people management experience Preferred: + 15+ years related pharmaceutical industry experience Significant expertise in mAbs, multispecifics, and antibody conjugate development through demonstrated and positive track record. Includes both early stage, late stage, and lifecycle management of portfolio and manufacturing process experience but not limited to the following: + mAbs, bispecifcs, trispecfics, Antibody conjugates + IND/IMPD, BLA/MAA, and sBLA/Type II variation review/approval experience for antibody conjugates. Demonstrated people management and matrix team leadership experience with a proven track record of directly 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 Antibody Conjugate 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 Antibody Conjugate Portfolio and development partners. Represents the group in external forums. The anticipated base pay range for this position is $193,000 to $333,500. 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. 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 .]

Created: 2024-11-30