Senior Manager/ Associate Director, CMC Commercial Supply Chain jobs in United States
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Celldex · 4 days ago

Senior Manager/ Associate Director, CMC Commercial Supply Chain

Celldex is a biotechnology company focused on advancing innovative therapies. The Senior Manager/Associate Director will oversee commercial CMC activities to support the global launch of their device combination products, managing supply chain tasks and collaborating with various internal and external stakeholders.

BiotechnologyHealth CareOncologyPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Oversee the implementation of Celldex’s commercial CMC activities to support global launch of our device combination products
Manage or develop supply chain related tasks (including distribution flow, packaging specification, artwork, packaging qualification, 3PL distribution set-up, master data, serialization) for the preparation, commercialization, and launch of Celldex products by closely working with internal colleagues in various functions including Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance, etc. and external parties (e.g. CDMO, 3PL, consultants, service providers, etc.)
Manage supply chain activities including procurement, importing/exporting product, planning, and coordinating packaging, labeling, distribution of drug product, risk reduction, and maintenance of adequate and optimized inventory level
Evaluate/ Select the artwork vendor for the generation of the label and carton designs and product insert
Oversee the Serialization effort and package tamper sealing requirements
Design and implement supply routes, specifications, timeline, and inventories
Develop and maintain demand forecasts for Celldex’s products starting in US then Globally as required for planning of product supply and propose appropriate demand volume and timing
Establish, manage, and control commercial product inventories across the supply chain including Drug Product CDMO, Packager, 3PL, and distributor. Employ best practices of inventory management strategies and tactics as well as preparing inventory management metrics such as safety stock, cycle stock, when relevant
Develop and maintain supply contracts and distribution agreements with all stakeholders
Support the evaluation, selection and quality audit of manufacturing, packaging/labeling, distribution, and supply chain related vendors and service providers. support of the commercial team and the integration with the packager including the capabilities for sample labeling and commercial distribution
Generate contracts, budgets and approve invoices for the activities supported
Act as Celldex Project Manager for the managed activities including overseeing timelines and deliverables being executed at contract sites

Qualification

Biologics supply chainCold chain managementSupply chain regulationsProject management toolsVendor managementContract managementInventory managementInterpersonal skills

Required

Bachelor's Degree in an engineering or life sciences related field
5+ relevant experience in biotech or pharmaceutical industry with 2+ years in biologics supply chain
Experience in managing cold chain products
Knowledge of supply chain US regulations (e.g., GMP, Serialization, Logistics)
Interpersonal skills to effectively manage internal and external communications
Able to travel 10-20% of time
Proficient in the use of project management tools

Preferred

Master's Degree
Experience handling drug and device combination products in US
Experience with supporting BLA submissions/ Product launch
Experience working with CDMOs, 3PL and other service providers is highly preferred

Benefits

Annual discretionary bonus
Long term incentive
401(K) plan with employer contribution
Health care and other insurance benefits (for employee and family)
Paid holidays
Vacation
Sick days

Company

Celldex

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Celldex is pioneering new horizons in immunology to deliver life-changing therapies.

H1B Sponsorship

Celldex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)

Funding

Current Stage
Public Company
Total Funding
$1.54B
2024-02-29Post Ipo Equity· $460.5M
2023-11-07Post Ipo Equity· $200.5M
2021-07-12Post Ipo Equity· $287.5M

Leadership Team

A
Anthony Marucci
President & CEO
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Ronald A. Pepin
Senior Vice President and Chief Business Officer
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Company data provided by crunchbase