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Apnimed

Clinical-stage biotech developing oral OSA therapies

Associate Director - Commercial Supply Chain

Supply Chain ManagementPosted on Nov 12
Full-timeRemote in USA

About the Job

Requirements

  • A bachelor's degree is required; a degree in Supply Chain, Business, or Life Sciences is preferred.
  • 7–10+ years of experience in a supply chain management role at an established biopharmaceutical company.
  • Experience leading and developing teams to deliver organizational growth initiatives.
  • Experience managing and implementing supplier relationship management (SRM) and sales and operations planning (S&OP) processes, and leading cross-functional teams to overcome hurdles and deliver project results on time and as expected.
  • Strong knowledge of supply chain processes and experience with supply chain systems, including enterprise resource planning (ERP), traceability tools, and supply chain planning modules.
  • Understanding of biotech/pharma manufacturing operations, commercial launch, and supply chain operations, with working knowledge of FDA regulations related to New Drug Applications, good manufacturing practices (GMP), serialization, and product packaging and labeling.
  • Extensive experience in supply chain strategic analysis and ability to recognize complex information arrangements to develop observations and recommendations that support strategic Commercial Supply Chain decision-making.
  • Ability to work on discrete and ad hoc Commercial Supply Chain strategic initiatives as directed.
  • Ability to manage simultaneous priorities and changing deadlines.
  • Ability to plan, organize, and prioritize work.
  • Proficiency in Microsoft Word and PowerPoint, and experience with Adobe Acrobat Professional.

Responsibilities

  • Lead and manage the entire primary and secondary packaging process at the contract packaging organization (CPO), ensuring compliance with regulations and standards, and oversee commercial packaging readiness, including serialization, artwork lifecycle management, and shipping lane validation.
  • Develop, lead, and implement packaging solutions, including technical transfers, validations, and qualifications of new packaging processes, with testing and analysis to assess packaging performance.
  • Ensure proper global serialization coding, barcoding, and Global Trade Item Number (GTIN) assignment for each stock-keeping unit (SKU), in accordance with current regulations and GS1 standards.
  • Own and generate monthly commercial supply plans, and develop, coordinate, prioritize, and maintain the sales and operations planning (S&OP) commercial strategy, working with Commercial Operations and Finance to translate demand plans and market analytics into actionable supply plans.
  • Collaborate with the Commercial Supply Chain team on strategic production planning activities, including long-term demand and supply planning as input for contract manufacturing organization (CMO) capacity planning and procurement planning, and align with the third-party logistics provider (3PL) to ensure commercial product supply meets demand.
  • Develop and manage 3PL and strategic supply partner relationships, monitor supplier performance, serve as the primary escalation point for risks and issues, and ensure adherence to contractual commitments, including milestone dates, financial terms, and production schedules.
  • Work cross-functionally to develop commercial supplier metric targets and key performance indicator (KPI) dashboards for quarterly business reviews (QBR) and the supplier relationship management governance process.
  • Work cross-functionally with Quality, CMC, Commercial, Regulatory, Accounting/Finance, and IT, and ensure commercial supply chain activities comply with applicable laws, regulations, GMP/GDP, and company policies.

About the Company

Apnimed

Clinical-stage biotech developing oral OSA therapies

Apnimed develops oral therapies for obstructive sleep apnea (OSA), focusing on the neurological causes of the condition. Its lead candidate, AD109, is intended to be a disease-modifying oral treatment that targets the underlying biology of OSA rather than just alleviating symptoms. This approach sets it apart from most current options, which rely on devices or surgery rather than drugs. The company aims to bring an approved oral medication to patients and generate revenue through commercialization after regulatory approval.

Company size
51-200
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2017

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