Senior Manager/ Associate Director, CMC Commercial Supply Chain
Celldex Therapeutics, Inc., Hampton, New Jersey, us, 08827
Overview
The position will support the commercialization of Celldex’s late-stage candidates by managing the activities necessary to launch Barzolvolimab globally from the commercial labeler/ packager up to final distribution . 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 Qualifications
Bachelor’s Degree in an engineering or life sciences related field. Master’s Degree preferred 5+ relevant experience in biotech or pharmaceutical industry with 2+ years in biologics supply chain Experience in managing cold chain products Experience handling drug and device combination products in US is a plus Experience with supporting BLA submissions/ Product launch is a plus. Knowledge of supply chain US regulations (e.g., GMP, Serialization, Logistics). Experience working with CDMOs, 3PL and other service providers is highly preferred. Interpersonal skills to effectively manage internal and external communications. Able to travel 10-20% of time. Proficient in the use of project management tools Compensation:
The expected base salary range for this position is$133,579 - $190,501. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Compensation for this role includes base salary, 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, and sick days. A summary of our benefits can be found on our careers page. Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach
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The position will support the commercialization of Celldex’s late-stage candidates by managing the activities necessary to launch Barzolvolimab globally from the commercial labeler/ packager up to final distribution . 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 Qualifications
Bachelor’s Degree in an engineering or life sciences related field. Master’s Degree preferred 5+ relevant experience in biotech or pharmaceutical industry with 2+ years in biologics supply chain Experience in managing cold chain products Experience handling drug and device combination products in US is a plus Experience with supporting BLA submissions/ Product launch is a plus. Knowledge of supply chain US regulations (e.g., GMP, Serialization, Logistics). Experience working with CDMOs, 3PL and other service providers is highly preferred. Interpersonal skills to effectively manage internal and external communications. Able to travel 10-20% of time. Proficient in the use of project management tools Compensation:
The expected base salary range for this position is$133,579 - $190,501. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Compensation for this role includes base salary, 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, and sick days. A summary of our benefits can be found on our careers page. Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach
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