Bachelor's degree in Supply Chain, Business, or Life Sciences required.
7-10+ years of supply chain management experience in biopharmaceuticals.
Proven leadership in developing teams for organizational growth.
Experience with SRM and S&OP processes and cross-functional project delivery.
Strong knowledge of supply chain processes and systems (ERP, traceability tools).
Understanding of biotech/pharma manufacturing and FDA regulations.
Skilled in strategic analysis for Commercial Supply Chain decision-making.
Responsibilities
Lead and manage primary and secondary packaging processes at CPO, ensuring regulatory compliance.
Develop and implement optimal packaging solutions, including validations and performance assessments.
Oversee serialization coding and barcoding for global compliance with GS1 standards.
Generate monthly commercial supply plans and coordinate S&OP strategy with Commercial Operations and Finance.
Collaborate on strategic production planning for CMO capacity and procurement alignment.
Manage relationships with 3PL and supply partners, monitoring performance and addressing risks.
Work cross-functionally to establish supplier metrics and KPI dashboards for QBRs.
Benefits
401(k) with company match
Generous time off for vacation
Comprehensive healthcare benefits
Flexible working environment
Supportive and experienced team
Recognized as a top workplace by Boston Business Journal in 2024
Full Job Description
The Associate Director, Commercial Supply Chain reports to the Senior Director, Supply and Manufacturing and is responsible for overseeing and managing all aspects of commercial drug supply, including production planning at CMOs, commercial packaging and labeling execution, logistics, and inventory management. The successful candidate will also play a key role in integrating closely with our internal commercial forecasting organization and managing daily business relationships with all of our strategic supply business partners. This is an exciting opportunity to help drive Apnimed's commercial success as part of a major paradigm shift in the treatment of sleep apnea from medical devices and surgery to a first in class pharmaceutical treatment.
The expected annual base salary range for this role is $160,000.00 to $180,000.00. Final compensation will depend on the selected candidate's level, education and relevant experience. Key Job Duties include, but are not limited to:
Lead and manage the entire primary and secondary packaging process at our 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 optimal packaging solutions, including technical transfers, validations, and qualifications of new packaging processes, with proper testing and analysis to assess packaging performance
Responsible for proper serialization coding, barcoding, and GTIN (for each SKU) globally, per current regulations and GS1 standards
Own and generate monthly commercial supply plans, and develop, coordinate, prioritize, and maintain the S&OP commercial strategy, working with Commercial Operations and Finance to translate demand plans and market analytics into actionable and robust supply plans
Collaborate with the Commercial Supply Chain team to establish strategic production planning activities (long-term demand and supply planning) as the input for CMO capacity planning and procurement planning, and align with the 3PL to ensure commercial product supply is available based on demand planning
Develop and manage 3PL and strategic supply partner business relationships, monitor supplier performance, serve as the primary point of escalation for risks and issues, and ensure adherence to contractual commitments, including milestone dates, financial terms, and production schedules
Work cross-functionally to develop targets for commercial suppliers' metrics and KPI dashboards for use in 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 all commercial supply chain activities comply with applicable laws, regulations, GMP/GDP, and internal company policies
Requirements
Bachelor's degree required, preferably in Supply Chain, Business or Life Sciences.
7-10+ years of experience in a supply chain management role in an established biopharmaceutical company.
Experience in leading and developing teams to deliver on organization growth initiatives.
Experience in managing and implementing SRM and 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 in supply chain systems (ERP, traceability tools, supply chain planning modules, etc.).
Understanding of biotech/pharma manufacturing operations, commercial launch, and supply chain operations, with working knowledge of FDA regulations related to New Drug Applications, GMP, serialization, and product packaging and labeling.
Highly experienced in supply chain strategic analysis and skilled at recognizing complex information arrangements to develop observations and recommendations that assist in 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.
Excellent oral and written communication skills.
Ability to plan, organize and prioritize work.
Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional.
Benefits
401(k) with company match
Generous time off for vacation
Generous healthcare benefits
Flexible working environment
Motivated and experienced team
Winner of 2024 Boston Business Journal Best Places to Work
Location and Other Information:
Apnimed is a publicly licensed company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical.
We are a small growing Company with an inclusive environment.
Must be able to travel as necessary.
Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.
