Ph3Job Details /h3ulliJob Function: Discovery Pre-Clinical/Clinical Development /liliJob Sub Function: Pharmaceutical Product RD /liliJob Category: Scientific/Technology /liliJob Posting Locations: Beerse, Antwerp, Belgium /li /ulh3Job Description /h3pThe 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). /ph3Key Responsibilities /h3ulliDriving strategic stakeholder alignment across development teams, regulatory agencies, IMSC, and the CDT to ensure clarity and agreement on CMC strategy and deliverables. /liliProactively influencing decisions at the CDT and within IMSC by integrating scientific, technical, and operational perspectives. /liliNavigating complex cross‑functional priorities to advance CMC readiness, manage risks, and support successful achievement of program milestones—from early development through commercial launch. /li /ulh3Essential Job Duties and Responsibilities /h3ulliDefine 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). /liliAdvance compounds by developing and executing a robust CMC development strategy aligned with the CMC Stage Gate process and securing timely approvals through governance bodies. /liliDeliver Best Process at Launch (BPAL) while meeting clinical commitments for CMC deliverables. /liliChallenge the science and timelines for process development, balancing time, cost, and risk. /liliCritically evaluate and challenge non‑clinical demand on API/DP requirements for formulation development, toxicology studies, and stability studies. /liliInfluence program deliverables (e.g., device selection, trial design, timelines, cost) and ensure strategic alignment within the CDT. /liliEnsure alignment within DPDS on portfolio strategies. /liliOptimize end‑to‑end (E2E) Phase 3/commercial strategy (e.g., minimizing comparability risks, aligning with clinical strategy, optimizing COGs) in partnership with the VCT. /liliEnsure strong cross‑functional collaboration between CMC and partners such as CMC RA, Quality, CPP, GCSO, and IMSC to maintain alignment on deliverables. /liliDrive cross‑functional alignment between JJ RD functions and IMSC on key CMC decisions. /liliMaintain awareness of strategic shifts within the program and clearly articulate implications, priorities, and required actions to drive aligned execution across functions. /liliProvide leadership and mentoring to CMC team members to support collaboration, skills development, and performance. /liliIdentify and lead the team in generating key technical deliverables needed for regulatory interactions and global filings. /liliLead the CMC team in completing required CMC regulatory documents and responses for clinical and commercial submissions. /liliEnsure the reliable delivery of clinical and launch drug supplies through strong cross‑functional coordination and robust CMC planning. /liliEnsure successful launch and sustained market supply continuity in alignment with GFLS, partnering with the VCT. /liliDrive smart, calculated risk‑taking as part of the overall compound development plan. /liliLead the CMC team in identifying, assessing, and mitigating CMC‑related risks, ensuring proactive planning and scenario management. /liliProvide transparent communication on CMC risks, mitigation strategies, and program implications to the CDT, VCT, and functional leadership. /liliOptimize the program’s spend profile by integrating clinical and CMC plans, scrutinizing/optimizing clinical supplies, and applying supply risk appropriately. /liliEnsure effective bidirectional communication with the CDT, VCT, cross‑functional teams, and functional leadership. /liliProvide timely updates and insights to support informed decision‑making across the development lifecycle. /liliWork closely with the CMC project manager (PM) to create and maintain the project planning and execution. /li /ulh3Additional Responsibilities /h3ulliIdentify opportunities for team or product development improvements across the DPDS organization and support or lead initiatives to deliver organizational or process improvements. /liliDemonstrate 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. /liliFocus 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. /li /ulh3Qualifications /h3ulliEducation 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. /liliCMC Expertise: Proven experience in CMC for small molecules and ability to apply CMC principles across diverse development platforms. /liliCommunication Skills: Excellent written and verbal communication; ability to translate complex technical, CMC, and regulatory topics into clear guidance. /liliLeadership Interpersonal Skills: Strong leadership, agility in evolving structures, cross‑functional teamwork, trust building, collaboration, and clarity. /liliCMC 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. /liliProgram Workstream Leadership: Proven ability to lead multiple CMC workstreams simultaneously; prioritization, risk management, and on‑time delivery. /liliInfluence Cross‑Functional Alignment: Ability to influence without direct authority across functions such as Process Development, Analytical, Quality, Regulatory CMC, Clinical Supply, and Manufacturing. /liliDecision Making Accountability: Capability to make complex CMC decisions with urgency, sound judgment, and follow‑through. /li /ulh3Required Skills /h3ulliBudget Management /liliChemistry, Manufacturing, and Control (CMC) /liliClinical Trial Protocols /liliConsulting /liliDesign Mindset /liliDrug Discovery Development /liliGood Governance /liliIndustry Analysis /liliInterdisciplinary Work /liliMarket Research /liliPresentation Design /liliProcess Improvements /liliProduct Development /liliProduct Licensing /liliProduct Strategies /liliRisk Management /liliScientific Research /li /ulh3Preferred Skills /h3ulliBudget Management /liliChemistry, Manufacturing, and Control (CMC) /liliClinical Trial Protocols /liliConsulting /liliDesign Mindset /liliDrug Discovery Development /liliGood Governance /liliIndustry Analysis /liliInterdisciplinary Work /liliMarket Research /liliPresentation Design /liliProcess Improvements /liliProduct Development /liliProduct Licensing /liliProduct Strategies /liliRisk Management /liliScientific Research /li /ulh3Benefits /h3ulliBase salary range: €119,200.00 – €204,355.00 /liliAnnual bonus with target percentage of pay dependent on grade/location. /liliVacation days. /liliParental leave for a minimum of 12 weeks. /liliBereavement leave. /liliCaregiver leave. /liliVolunteer leave. /liliWell‑being reimbursement and programs for financial, physical and mental health. /liliService anniversary and recognition awards. /liliInsurance plans for employees and eligible dependents. /li /ul /p #J-18808-Ljbffr