Job Details
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Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Pharmaceutical Product R&D
Job Category: Scientific/Technology
Job Posting Locations: Beerse, Antwerp, Belgium
Job Description
The 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), the Therapeutic Areas (TAs), and the Value Chain Team (VCT) representing the Innovative Medicine Supply Chain (IMSC). The CMC Leader oversees cross‑functional CMC teams from pre‑New Molecular Entity (pre‑NME) through post‑approval, including Life Cycle Management (LCM).
Key Responsibilities
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 milestones—from early development through commercial launch.
Essential Job Duties and Responsibilities
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 program’s 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 planning and execution.
Additional Responsibilities
Identify opportunities for team or product development improvements across the DPDS organization and support or lead initiatives to deliver organizational or process improvements.
Demonstrate behaviors consistent with the current CEO Framework (Compete, Execute, Optimize) and mentor and coach CMC team members to improve their skills and contributions with line management.
Focus on compound development projects that may span multiple Therapeutic Areas and/or IMSC LCM, demonstrating team leadership skills and experience in a multi‑disciplinary, highly matrixed environment with evidence of delivering results.
Qualifications
Education & Experience: Bachelor’s degree in life sciences or a related field with 8+ years of experience in pharmaceutical, biotechnology, or related industry, or Master’s 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 and ability to apply CMC principles across diverse development platforms.
Communication Skills: Excellent written and verbal communication; ability to translate complex technical, CMC, and regulatory topics into clear guidance.
Leadership & Interpersonal Skills: Strong leadership, agility in evolving structures, cross‑functional teamwork, trust building, collaboration, and clarity.
CMC Strategy & Execution: Experience developing and implementing CMC development and regulatory strategies for biologics, small molecules, or cell & gene therapy programs; integration of scientific, technical, and quality aspects; support for IND/IMPD, MAA readiness, and lifecycle management.
Program & Workstream Leadership: Proven ability to lead multiple CMC workstreams simultaneously; prioritization, risk management, and on‑time delivery.
Influence & Cross‑Functional Alignment: Ability to influence without direct authority across functions such as Process Development, Analytical, Quality, Regulatory CMC, Clinical Supply, and Manufacturing.
Decision Making & Accountability: Capability to make complex CMC decisions with urgency, sound judgment, and follow‑through.
Required Skills
Budget Management
Chemistry, Manufacturing, and Control (CMC)
Clinical Trial Protocols
Consulting
Design Mindset
Drug Discovery Development
Good Governance
Industry Analysis
Interdisciplinary Work
Market Research
Presentation Design
Process Improvements
Product Development
Product Licensing
Product Strategies
Risk Management
Scientific Research
Preferred Skills
Budget Management
Chemistry, Manufacturing, and Control (CMC)
Clinical Trial Protocols
Consulting
Design Mindset
Drug Discovery Development
Good Governance
Industry Analysis
Interdisciplinary Work
Market Research
Presentation Design
Process Improvements
Product Development
Product Licensing
Product Strategies
Risk Management
Scientific Research
Benefits
Base salary range: €119,200.00 – €204,355.00
Annual bonus with target percentage of pay dependent on grade/location.
Vacation days.
Parental leave for a minimum of 12 weeks.
Bereavement leave.
Caregiver leave.
Volunteer leave.
Well‑being reimbursement and programs for financial, physical and mental health.
Service anniversary and recognition awards. xphnsxz
Insurance plans for employees and eligible dependents.
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