Sr. Manager Clinical Supply Operations
BioSpace · Somerset, NJ · 1 mo ago
On-siteManagement$146k–$192k/yrFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes "Role Overview" and "Key Responsibilities", "Requirements", "Benefits and Paid Time Off", "Pay Range (Base Pay)". Also maybe "Other Types of Pay". We need to use for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We must not repeat job title as heading. No Job ID. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove "Work Authorization & Employment Eligibility", "EEO Statement", etc. Also remove "Please note: These benefits are offered exclusively to permanent full-time employees." Might be considered part of benefits? It's a note; but we can keep as part of benefits paragraph? It's not boilerplate? It's a clarification about benefits eligibility; could keep but maybe it's okay. However it's not required to remove. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The benefits note is not exactly that; it's a clarification. We can keep.
We need to preserve all substantive information. So we need to include role overview paragraph, responsibilities list, requirements list, benefits paragraph, pay range paragraph, other types of pay maybe as part of benefits? Could be separate "Other Types of Pay" but not a standard heading; we could incorporate into Benefits or Pay. The instruction says use headings for Benefits, Pay, Schedule. So we can have a Benefits section (including medical, dental, vision, 401k, parental leave, PTO, voluntary benefits, commuter benefits, etc.) and a Pay section (including base pay range and performance-based bonus/equity). No Schedule info present, so we omit Schedule heading.
We also need About the role? Could use "About the role" heading for role overview paragraph. Or we could use "Role Overview" but instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should map content to those headings. Use About the role for role overview paragraph. Responsibilities for key responsibilities list. Requirements for requirements list. Qualifications maybe not present; we could omit if no specific content. Skills maybe not separate; we could omit. Benefits for benefits. Pay for pay range and other types of pay. No Schedule.
We must not emit heading with filler/placeholder text. So only include sections where we have real content.
Thus output:
for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We must not repeat job title as heading. No Job ID. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove "Work Authorization & Employment Eligibility", "EEO Statement", etc. Also remove "Please note: These benefits are offered exclusively to permanent full-time employees." Might be considered part of benefits? It's a note; but we can keep as part of benefits paragraph? It's not boilerplate? It's a clarification about benefits eligibility; could keep but maybe it's okay. However it's not required to remove. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The benefits note is not exactly that; it's a clarification. We can keep.
We need to preserve all substantive information. So we need to include role overview paragraph, responsibilities list, requirements list, benefits paragraph, pay range paragraph, other types of pay maybe as part of benefits? Could be separate "Other Types of Pay" but not a standard heading; we could incorporate into Benefits or Pay. The instruction says use headings for Benefits, Pay, Schedule. So we can have a Benefits section (including medical, dental, vision, 401k, parental leave, PTO, voluntary benefits, commuter benefits, etc.) and a Pay section (including base pay range and performance-based bonus/equity). No Schedule info present, so we omit Schedule heading.
We also need About the role? Could use "About the role" heading for role overview paragraph. Or we could use "Role Overview" but instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should map content to those headings. Use About the role for role overview paragraph. Responsibilities for key responsibilities list. Requirements for requirements list. Qualifications maybe not present; we could omit if no specific content. Skills maybe not separate; we could omit. Benefits for benefits. Pay for pay range and other types of pay. No Schedule.
We must not emit heading with filler/placeholder text. So only include sections where we have real content.
Thus output:
About the role
Legend Biotech is seeking a Sr. Manager Clinical Supply Operations as part of the Technical Operations team based in Somerset, NJ. Role Overview Legend Biotech is seeking an experienced and driven Sr. Manager- Clinical Supply Operations to join our Technical Development team. This role will report to the Director of Patient Supply Strategy & Operations and be responsible for supporting hands on execution of global patient supply activities for early clinical Cell and Gene Therapy programs (Allogenic and In-Vivo). This role will coordinate investigational product planning, packaging and labeling, distribution, inventory, quality release, returns, reconciliation, and destruction across clinical sites, depots, CROs, and external vendors. The successful candidate will bring strong operational discipline, systems proficiency, vendor coordination, and cross-functional partnership to help ensure continuous, compliant supply of clinical trial material.
But note we have duplicated "Role Overview" sentence; we should combine and avoid duplication. The original text had "Role Overview Legend Biotech is seeking..." after first sentence. We'll just produce a concise paragraph preserving all info. We need to ensure we don't repeat sentences. Let's craft: Legend Biotech is seeking a Sr. Manager Clinical Supply Operations as part of the Technical Operations team based in Somerset, NJ. The role reports to the Director of Patient Supply Strategy & Operations and supports hands‑on execution of global patient supply activities for early‑stage cell and gene therapy programs (allogeneic and in‑vivo). Responsibilities include coordinating investigational product planning, packaging and labeling, distribution, inventory, quality release, returns, reconciliation, and destruction across sites, depots, CROs, and vendors; maintaining inventory visibility; managing temperature excursions, expiry risk, documentation gaps, and shipment issues; translating cross‑functional inputs into supply actions; executing clinical supply plans; developing demand forecasts, inventory reconciliations, expiry tracking; overseeing IRT and inventory systems; ensuring inspection‑ready documentation; coordinating packaging, labeling, QA/QP release, logistics, vendor management; partnering with Clinical Operations, CMC, Quality, Regulatory, Technical Development; identifying process improvements; supporting deviations, investigations, CAPAs; leading meetings and mentoring junior staff. That covers responsibilities but we also need a separate Responsibilities section list. So About the role can be a brief overview; Responsibilities will be a list. Thus About the role paragraph: Legend Biotech is seeking a Sr. Manager Clinical Supply Operations as part of the Technical Operations team based in Somerset, NJ. The role reports to the Director of Patient Supply Strategy & Operations and supports hands‑on execution of global patient supply activities for early‑stage cell and gene therapy programs (allogeneic and in‑vivo). Then Responsibilities- ... each bullet.
We need to preserve all substantive responsibilities from the "Key Responsibilities" section. Let's extract them:
- Coordinating supply activities across multiple studies, countries, sites, depots, vendors, and systems.
- Maintaining accurate inventory visibility while protocols, enrollment forecasts, shelf life, and country requirements evolve.
- Managing temperature excursions, expiry risk, documentation gaps, shipment issues, and competing operational priorities.
- Translating cross-functional inputs into timely, practical clinical supply actions and clear follow-up.
- Reliable execution of clinical supply plans, packaging and labeling activities, releases, and global distribution.
- Accurate demand forecasts, inventory reconciliations, expiry tracking, returns, and destruction records.
- Effective use and oversight of IRT, inventory, vendor, and documentation systems to maintain supply visibility and data integrity.
- Clear operational metrics, risk tracking, issue escalation, and inspection-ready clinical supply documentation.
- Execute day-to-day clinical drug supply activities across assigned trials to maintain availability of investigational product.
- Develop and maintain demand forecasts, supply plans, resupply parameters, inventory targets, and risk-mitigation actions in alignment with enrollment and protocol assumptions.
- Coordinate packaging, labeling, distribution, returns, reconciliation, and destruction activities with internal teams, CROs, depots, clinical sites, and external vendors.
- Support studies from start-up through closeout, including early-phase programs and evolving study requirements.
- Maintain clinical supply plans, pharmacy manuals, distribution instructions, and other study-specific operational documentation.
- Coordinate clinical label text, translation, review, approval, packaging, and pack-and-label reconciliation for global studies.
- Coordinate QA and, where applicable, QP release activities and ensure required documentation is complete before distribution.
- Manage distribution activities and shipment documentation in partnership with logistics providers, depots, customs support, and study teams.
- Coordinate temperature-excursion assessment, expiry management, product disposition follow-up, and documentation closure.
- Support inspection readiness by maintaining complete, accurate, and traceable clinical supply records, including eTMF filing as required.
- Serve as the operational point of contact for assigned packaging, labeling, depot, logistics, IRT, and other clinical supply vendors.
- Track vendor deliverables, timelines, performance, documentation, risks, and issue resolution; escalate when needed.
- Partner with Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, Technical Development, and external partners on shelf life, inventory strategy, country needs, and study execution.
- Identify process gaps and implement fit-for-purpose improvements that support compliance, cost, timelines, data quality, and supply continuity.
- Support deviations, investigations, CAPAs, change controls, suspected non-compliance assessments, and governance activities related to clinical supply operations.
- Independently manage assigned studies and workstreams, prioritize competing activities, and provide clear status and risk updates.
- Lead operational meetings and ensure decisions, actions, owners, and due dates are documented and followed through.
- Provide guidance to junior team members and contribute to SOPs, work instructions, training, and continuous improvement as the function scales.
That's many bullets. We'll output as
- each.
Now Requirements section: list each requirement bullet.
From Requirements:
- Bachelor’s degree in supply chain, life sciences, pharmacy, business, or a related discipline; equivalent relevant experience may be considered.
- Advanced degree or relevant clinical supply certification is preferred but not required.
- 6+ years of progressive experience in clinical supply operations, clinical drug supply, pharmaceutical supply chain, or closely related GMP operations within a sponsor, CRO, or clinical supply service provider environment.
- Demonstrated independent ownership of multiple studies, vendors, complex workstreams, or operational improvements is expected.
- Hands-on experience with clinical supply planning, demand forecasting, packaging and labeling, distribution, inventory management, reconciliation, returns, and destruction.
- Experience supporting global clinical trials and working with clinical sites, depots, CROs, packaging providers, logistics partners, and other external vendors.
- Experience with IRT and clinical supply or inventory systems; familiarity with CTMS, eTMF, vendor portals, ERP, reporting tools, or related platforms is preferred.
- Working knowledge of GMP requirements, QA/QP release, temperature excursions, expiry management, inspection readiness, and clinical trial documentation.
- Experience with oncology, biologics, cell and gene therapy, or other complex temperature-controlled products is preferred, not required.
- Strong operational ownership, attention to detail, follow-through, and ability to work independently in a fast-moving environment.
- Ability to interpret study needs, inventory data, forecasts, and system outputs and translate them into timely supply actions.
- Effective vendor-management skills, including timeline tracking, issue resolution, escalation, and performance follow-up.
- Comfort working across multiple systems and maintaining accurate, inspection-ready documentation.
- Strong problem-solving, risk-management, prioritization, and process-improvement skills.
- Clear written and verbal communication and the ability to collaborate effectively across Clinical Operations, CMC, Quality, Regulatory, Technical Development, and external partners.
- Ability to manage multiple studies and priorities while maintaining compliance, responsiveness, and supply continuity.
We'll output as list.
Benefits section: from Benefits and Paid Time Off paragraph.
We need to capture all benefits: Medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; eight (8) weeks of paid parental leave after just three (3) months of employment; paid time off policy includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays; additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.
Also note: "Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech." We can include that as a sentence.
Thus Benefits
- ... maybe each benefit as bullet.
Pay section: Base pay range $146,410 - $192,164 USD; Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
We'll include both in Pay section maybe as two paragraphs or list.
We must not include Schedule heading.
Now ensure we don't include any boilerplate like EEO, Work Authorization, etc.
We must output only HTML fragment, no markdown fences.
Let's craft final HTML.
We'll start with
About the role
...
ThenResponsibilities
- ...
Requirements
- ...
Benefits
- ...
Pay
- ... maybe each benefit as bullet.
Pay section: Base pay range $146,410 - $192,164 USD; Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
We'll include both in Pay section maybe as two paragraphs or list.
We must not include Schedule heading.
Now ensure we don't include any boilerplate like EEO, Work Authorization, etc.
We must output only HTML fragment, no markdown fences.
Let's craft final HTML.
We'll start with
- each.
Now Requirements section: list each requirement bullet.
From Requirements:
- Bachelor’s degree in supply chain, life sciences, pharmacy, business, or a related discipline; equivalent relevant experience may be considered.
- Advanced degree or relevant clinical supply certification is preferred but not required.
- 6+ years of progressive experience in clinical supply operations, clinical drug supply, pharmaceutical supply chain, or closely related GMP operations within a sponsor, CRO, or clinical supply service provider environment.
- Demonstrated independent ownership of multiple studies, vendors, complex workstreams, or operational improvements is expected.
- Hands-on experience with clinical supply planning, demand forecasting, packaging and labeling, distribution, inventory management, reconciliation, returns, and destruction.
- Experience supporting global clinical trials and working with clinical sites, depots, CROs, packaging providers, logistics partners, and other external vendors.
- Experience with IRT and clinical supply or inventory systems; familiarity with CTMS, eTMF, vendor portals, ERP, reporting tools, or related platforms is preferred.
- Working knowledge of GMP requirements, QA/QP release, temperature excursions, expiry management, inspection readiness, and clinical trial documentation.
- Experience with oncology, biologics, cell and gene therapy, or other complex temperature-controlled products is preferred, not required.
- Strong operational ownership, attention to detail, follow-through, and ability to work independently in a fast-moving environment.
- Ability to interpret study needs, inventory data, forecasts, and system outputs and translate them into timely supply actions.
- Effective vendor-management skills, including timeline tracking, issue resolution, escalation, and performance follow-up.
- Comfort working across multiple systems and maintaining accurate, inspection-ready documentation.
- Strong problem-solving, risk-management, prioritization, and process-improvement skills.
- Clear written and verbal communication and the ability to collaborate effectively across Clinical Operations, CMC, Quality, Regulatory, Technical Development, and external partners.
- Ability to manage multiple studies and priorities while maintaining compliance, responsiveness, and supply continuity.
We'll output as list.
Benefits section: from Benefits and Paid Time Off paragraph.
We need to capture all benefits: Medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; eight (8) weeks of paid parental leave after just three (3) months of employment; paid time off policy includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays; additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.
Also note: "Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech." We can include that as a sentence.
Thus Benefits