CMC Leader Synthetics Portfolio Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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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 CMC Leader is responsible for leading the CMC team within Therapeutic Development & Supplies (TDS) and serves as the single point of accountability to the Compound Development Team (CDT) which operates through the Therapeutic Areas (TAs) and to the Value Chain Team (VCT) representing the Innovative Medicine Supply Chain (IMSC).

The CMC Leader oversees multiple cross-functional CMC teams from pre-New Molecular Entity (pre-NME) through post-approval including Life Cycle Management (LCM).

Key responsibilities include:

• Driving strategic stakeholder alignment across development teams regulatory agencies IMSC and the CDT to ensure clarity and agreement on CMC strategy and deliverables.
• Proactively influencing decisions at the CDT and within IMSC by integrating scientific technical and operational perspectives.
• Navigating complex cross-functional priorities to advance CMC readiness manage risks and support successful achievement of program milestonesfrom early development through commercial launch.

• Define the CMC asset strategy and document it in the Asset Development Plan (ADP); lead the team in executing early- and late-phase development to deliver on the CMC Target Product Profile (TPP).
• Advance compounds by developing and executing a robust CMC development strategy aligned with the CMC Stage Gate process and securing timely approvals through governance bodies.
• Deliver Best Process at Launch (BPAL) while meeting clinical commitments for CMC deliverables.
• Challenge the science and timelines for process development balancing time cost and risk.
• Critically evaluate and challenge non-clinical demand on API/DP requirements for formulation development toxicology studies and stability studies.
• Influence program deliverables (e.g. device selection trial design timelines cost) and ensure strategic alignment within the CDT.
• Ensure alignment within DPDS on portfolio strategies.
• Optimize end-to-end (E2E) Phase 3/commercial strategy (e.g. minimizing comparability risks aligning with clinical strategy optimizing COGs) in partnership with the VCT.
• Ensure strong cross-functional collaboration between CMC and partners such as CMC RA Quality CPP GCSO and IMSC to maintain alignment on deliverables.
• Drive cross-functional alignment between J&J R&D functions and IMSC on key CMC decisions.
• Maintain awareness of strategic shifts within the program and clearly articulate implications priorities and required actions to drive aligned execution across functions.
• Provide leadership and mentoring to CMC team members to support collaboration skills development and performance.
• Identify and lead the team in generating key technical deliverables needed for regulatory interactions and global filings.
• Lead the CMC team in completing required CMC regulatory documents and responses for clinical and commercial submissions.
• Ensure the reliable delivery of clinical and launch drug supplies through strong cross-functional coordination and robust CMC planning.
• Ensure successful launch and sustained market supply continuity in alignment with GFLS partnering with the VCT.
• Drive smart calculated risk-taking as part of the overall compound development plan.
• Lead the CMC team in identifying assessing and mitigating CMC-related risks ensuring proactive planning and scenario management.
• Provide transparent communication on CMC risks mitigation strategies and program implications to the CDT VCT and functional leadership.
• Optimize the programs spend profile by integrating clinical and CMC plans
• scrutinizing/optimizing clinical supplies and applying supply risk appropriately.
• Ensure effective bidirectional communication with the CDT VCT cross-functional teams and functional leadership.
• Provide timely updates and insights to support informed decision-making across the development lifecycle.
• Work closely with the CMC project manager (PM) to create and maintain the project

The CMC Leader will help to identify opportunities for team or product development improvements across the DPDS organization. They may also support or lead teams in implementing initiatives to deliver organizational or process improvements.

The CMC Leader is expected to demonstrate behaviors consistent with the current C.E.O Framework (Compete Execute Optimize). They will also be responsible for mentoring and coaching CMC Team Members to improve their skills and contributions to the organization in collaboration with line management.

The CMC Leader is primarily focused on the compound development projects they lead which may span multiple Therapeutic Areas (TAs) and/or IMSC LCM. They will have demonstrated team leadership skills (as a team member or a team leader) and experience working in a multi-disciplinary highly matrixed environment with evidence of delivering results in this setting including In-depth experience and technical knowledge of the CMC development process preferably including an understanding of early late and LCM development

Minimum Qualifications

Education & Experience

• Bachelors degree in life sciences or a related field with 8 years of experience inpharmaceutical biotechnology or related industry; or
• Masters degree with 6 years of relevant experience; or
• Ph.D. with 4 years of industry experience.

CMC Expertise

• Proven experience in CMC for small molecules
• Ability to apply CMC principles across diverse development platforms.

Communication Skills

• Excellent written and verbal communication skills.
• Ability to translate complex technical CMC and regulatory topics into clear actionable guidance for internal teams external partners and senior leaders.
• Strong capabilities in conflict resolution and negotiation aligning stakeholders with varying priorities.

Leadership & Interpersonal Skills

• Strong leadership skills with the agility to work within evolving structures cross-functional environments and global teams.
• Skilled in building trust fostering collaboration and providing clarity in dynamic or rapidly changing situations.

CMC Strategy & Execution

• Demonstrated experience developing and implementing CMC development and regulatory strategies for biologics small molecules or cell & gene therapy programs.
• Ability to integrate scientific technical and quality aspects across drug substance drug product analytics and supply chain.
• Experience supporting IND/IMPD MAA readiness and lifecycle management.

Program & Workstream Leadership

• Proven ability to lead multiple CMC workstreams simultaneously.
• Strong prioritization risk management and on-time delivery of critical program activities.

Influence & Cross-Functional Alignment

• Ability to influence without direct authority driving alignment across functions such as Process Development Analytical Quality Regulatory CMC Clinical Supply and Manufacturing.
• Ensures coordinated and cohesive execution of program objectives.

Decision Making & Accountability

• Capable of making complex CMC decisions with urgency and sound judgment balancing scientific regulatory and operational factors.
• Strong follow-through and organizational discipline to keep cross-functional teams aligned informed and accountable throughout the program lifecycle.

#DPDS

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.