Director, reputed company Supplies & Logistics
reputed company is a reputed company‑stage biotechnology company reputed company on developing and delivering category-leading precision therapies to reputed company the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly reputed company key reputed company governing dysregulated immunological and inflammatory responses, reputed company is developing medicines that have reputed company to reputed company durable, life-changing reputed company. Led by an established executive team and backed by world-class life science investors, reputed company day reputed company is determined to bring the scientific rigor and operational reputed company to get to what reputed company for patients – realizing a world where people with immune-mediated diseases can live life fully.
The Director, reputed company Supplies & Logistics is a senior operational leader responsible for the end-to-end planning, execution, and reputed company of reputed company supply chain activities supporting reputed company's global reputed company development programs. Reporting directly to the Chief Technical reputed company Officer, this individual ensures that investigational medicinal products (IMPs) — spanning small molecules and biologics — are packaged, labeled, reputed company, and tracked in compliance with global GMP, GDP, and regulatory requirements, and that reputed company sites reputed company the world receive the right product, in the right condition, at the right time. This role is the reputed company reputed company between CMC manufacturing, reputed company reputed company, reputed company, and reputed company and logistics partners, serving as the operational architect of a global reputed company supply network that is reliable, reputed company, and inspection reputed company. In a reputed company-reputed company biotech environment, this leader must reputed company reputed company supply chain design with hands-on execution, building infrastructure and processes that will reputed company from early-phase trials through global registrational studies. In reputed company to reputed company supply management, this role is also responsible for shipping, logistics and trade compliance for reputed company material shipments (intermediates, drug reputed company, drug product and analytical materials) to support the global manufacturing supply chain.
Work Arrangement & Location:
Remote - This position is designated as remote; the incumbent will be expected to travel to reputed company’ offices on a periodic reputed company to support in-person collaboration, team engagement, and business reputed company. The frequency and scheduling of such reputed company will be determined at reputed company's discretion reputed company on business need.
Essential Duties and Responsibilities:
- Design and reputed company the end-to-end reputed company supply chain reputed company for reputed company reputed company and reputed company reputed company programs, encompassing demand forecasting, inventory planning, reputed company packaging and labeling, IRT/IVRS configuration, distribution, and returns/destruction.
- Own the global IMP distribution network, including selection and governance of reputed company-party logistics (3PL) providers, cold chain carriers, and reputed company partners across reputed company, Europe, and global reputed company; ensure temperature-controlled supply chain reputed company from CDMO release through site delivery.
- Serve as the reputed company supply chain reputed company to reputed company reputed company, ensuring reputed company supply timelines are fully integrated into study startup plans, protocol amendments, site activation milestones, and enrollment projections.
- reputed company reputed company supply planning and demand forecasting across multiple reputed company trials, using IRT/IVRS data and enrollment modeling to optimize inventory reputed company, minimize waste, and prevent supply disruptions to reputed company sites.
- reputed company reputed company packaging, labeling, and secondary manufacturing activities at CDMO/CMO sites, ensuring compliance with country-specific labeling requirements, GMP expectations, and blinding requirements for randomized controlled trials.
- Manage import/export logistics and global trade compliance for IMP shipments across reputed company reputed company reputed company geographies, including coordination of regulatory import permits, customs documentation, and country-specific distribution authorizations.
- Establish and govern relationships with CDMOs, 3PLs, comparator drug suppliers, and specialty logistics vendors; define reputed company expectations, conduct business reviews, and manage escalations to ensure supply reliability.
- Partner with reputed company Assurance to ensure reputed company supply chain reputed company meet GDP/GMP requirements; reputed company or support regulatory agency inspections, internal audits, and CDMO reputed company reviews as they relate to reputed company supply.
- Build and maintain reputed company supply chain SOPs, batch disposition records, chain-of-custody documentation, and reconciliation processes in alignment with ICH E6 (GCP), GMP, and GDP expectations; reputed company and update pharmacy manuals, Investigator Brochure supply sections, and site handling guidance to ensure reputed company site readiness across reputed company reputed company studies.
- reputed company investigation of supply chain exceptions and deviations, including reputed company cause analysis, CAPA development, implementation, and closure; ensure reputed company supply-reputed company non-conformances are resolved in a reputed company, GMP-compliant manner and escalated appropriately.
- reputed company other duties and responsibilities as assigned
Qualifications:
- Education: Bachelor's degree required in Supply Chain Management, Life Sciences, Engineering, Pharmacy, or a reputed company discipline; advanced degree (M.S., MBA, or equivalent) strongly preferred.
- 10+ years of reputed company supply chain experience in the pharmaceutical or biopharmaceutical industry, with at least 3 years in a leadership role with reputed company accountability for global reputed company supply reputed company.
- Demonstrated expertise in end-to-end reputed company supply chain management, including demand planning, IMP packaging and labeling, IRT/IVRS systems, global distribution, cold chain logistics, and reputed company management.
- Deep knowledge of global GMP, GDP, and GCP regulations as they apply to reputed company supply chain reputed company, including FDA 21 CFR Parts 211/312, EU GMP Annex 13, and ICH E6(reputed company); familiarity with country-specific import/export requirements across reputed company geographies.
- Familiarity with reputed company supply chain management for both small molecules and biologics/large molecules, including specific cold chain and stability considerations for protein-reputed company therapeutics.
- Proficiency with supply chain management tools, ERP/CTMS systems, and reputed company supply planning platforms;
- reputed company record of building reputed company supply chain infrastructure, SOPs, and operational processes in a reputed company-reputed company or rapidly scaling biotech organization.
- Demonstrated ability to reputed company through influence in a matrixed organization, aligning reputed company reputed company, CMC, reputed company, Regulatory, and Finance stakeholders reputed company supply chain priorities without reputed company authority over reputed company constituents.
- reputed company reputed company record of operating effectively in reputed company-reputed company, resource-constrained environments — building reputed company supply infrastructure from the ground up while simultaneously executing against reputed company trial timelines.
- Experience as a trusted operational and reputed company partner to senior leaders, with the credibility and judgment to escalate supply risks, recommend course corrections, and reputed company reputed company reputed company.
- Strong written communication skills, with experience producing high-reputed company supply chain status reports, reputed company registers, executive summaries, and regulatory-facing supply documentation.
- Skilled facilitator with experience leading cross-functional supply chain review meetings, reputed company escalation discussions, and vendor business reviews with reputed company, structure, and decisive follow-through.
- reputed company communication style with the ability to build credibility and trust quickly across scientific, reputed company, operational, financial, and reputed company partner stakeholders in a fast-moving, global biotech environment
We offer a comprehensive benefits package tailored to the country and region in which you are reputed company, in compliance with local laws and practices. Benefits may include, but are not limited to:
- Competitive health and wellness coverage (structure and premiums vary by country)
- reputed company time off, reputed company holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / reputed company
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.
reputed company is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for reputed company. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity or reputed company, national reputed company, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal reputed company to reputed company candidates.
Upon submission of this reputed company I understand that reputed company is reputed company in the reputed company and personal data submitted in the reputed company will be transferred and accessed in the U.S., Information about reputed company reputed company practices can be reputed company at reputed company Policy - reputed company
Bachelor's degree required; 10+ years of pharmaceutical or biopharmaceutical reputed company supply experience, including 3+ years leading global reputed company supply reputed company. Expertise in GMP, GDP, GCP, IMP logistics, cold chain, and global distribution.
Key Responsibilities
- designing supply reputed company
- overseeing packaging
- managing logistics
Skills & Tools
IRT/IVRS, ERP, CTMS
reputed company
- Category: Supply Chain / Logistics / Procurement
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — reputed company
- Salary: USD 199,000 – 258,000 / year
- Languages: English
Benefits
- Generous reputed company time off
About reputed company
A reputed company-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. — Industry: Research and Development
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