- Collaborate with CMC, Logistics, Quality Control, Quality Assurance, and Clinical Operations to develop and maintain a valid demand and supply plan, ensure the availability of products for patients, and support the company's business objectives
- Maintain an understanding of external manufacturing site capacities, capabilities, and supply risks
- Optimize supply chain processes and drive efficiency
- Scenario planning of demand and supply assumptions as we drive to commercialization
- Lead monthly demand and supply planning meetings with cross functional team members as part of our drive to a formal Integrated Business Planning / Sales and Operations Planning process
- Perform analysis of Dyne portfolio, including inventory projection, supply performance and risks
- Integrate with other global planning processes to monitor key performance indicators (KPIs) and analyze supply chain data to identify opportunities for improvement and cost savings (e.g. Demand, Inventory, Sales and Operations Planning process and Key Performance Indicators )
- Author Supply Chain-related standard operating procedures (SOPs) and work instructions
- Work within Interactive Response Technology(s) to verify and adjust clinical site and depot inventories
- Manage relationships with third-party suppliers and vendors to ensure timely delivery of materials and components
- Implement risk mitigation strategies to address supply chain processes and streamline operations
- Ensure compliance with regulatory requirements and quality standards in supply chain operations
Education and Skills Requirements: - Bachelor's Degree in Engineering, Supply Chain, Business or related field, or equivalent with 8+ years of related work experience in a biotechnology company
- Ability to effectively plan, prioritize, execute, follow up and anticipate challenges
- Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments
- Ability to work, influence, and gain agreement across multiple functions (Manufacturing, Quality and CMC)
- Strong analytical, problem solving and critical thinking skills
- Strong knowledge of supply chain best practices, inventory management, and demand forecasting
- Expertise in use of MS Excel, as well as demonstrated proficiencies in Smartsheet, Visio, ERP systems and Power BI (or similar application)
- Collaborative work style to be part of a team to identify process gaps and develop solutions
- Excellent interpersonal, verbal, and written communication skills
- Advanced analytical and problem-solving skills
- Experience in working with CMC Teams
- Experience in supply chain, drug development, project management, and/or pharmaceutical manufacturing/packaging
- In-depth working knowledge of regulations relating to clinical manufacturing, packaging and distribution activities (CGMP, GCP)
- APICS or CSCMP certification a plus
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. -
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Associate Director, Supply Chain Planning - Waltham, United States - Dyne Therapeutics
Description
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The Associate Director of Supply Chain Planning is responsible for inventory planning and tracking for Dyne's end-to-end external supply chain, maintaining a production plan that includes long range planning (LRP), ensuring continuous clinical supply, and commercial launch readiness builds and scenario planning for our assets. This role is instrumental in executing our current supply planning and in helping us develop and implement our future capabilities There role collaborates closely with Process Development, Research, CMC, and Quality Control and Quality Assurance. The person in this role is a strategic and results-driven professional with experience in collaborative supply chain planning.
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.
Primary Responsibilities Include:
