Director Supply Chain

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Job description

Company Overview
At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.
Job Summary
We are seeking a Director Supply Chain who is experienced, highly energetic, and committed to developing and executing Avidity's supply strategy across all clinical and pre-clinical programs. This individual will be responsible for designing, building and shaping Avidity's supply chain capability for future growth into multiple clinical studies and commercial launch. The individual will be responsible for demand management and inventory tracking in Avidity's ERP system, supply planning, vendor forecast management, logistics and cross-functional communication across Avidity's network. In addition, the Director Supply Chain will implement cGMP planning tools across all stages of manufacturing to ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of cGMP supply and experience working with manufacturing and distribution operations as well as knowledge of cGMP and FDA/EMA guidelines is required. The Director Supply Chain will also provide support to Avidity's procurement team and existing shipping/logistics network.
Essential Duties and Responsibilities

• Provide strategic and operational leadership with respect to Avidity's global supply chain function including demand/supply/capacity planning, sourcing, clinical labeling, packaging, inventory management, cold chain shipping, import/export and distribution.
• Assume responsibility for tracking changes in forecast requirements for pre-clinical and clinical studies.
• Track mAb, drug substance, SiRNA, PMO and DP inventory across all internal and external manufacturing sites. Work with the stability team lead to ensure that expiry and retest dating is current and fully aligned with the supply plan.
• Support clinical packaging sites, as needed, and ensure clinical drug inventory levels are maintained in accordance with study plans.
• Manage the manufacturing plans across all CMOs and ensure communication of forecasts to manufacturing partners.

• Support logistics operations of import/export of GMP and non-GMP materials.
• Support year-end cycle counts at vendor locations.
• Work with the Quality team to establish temperature monitoring policy at the shipping conditions established for all GMP materials.
• Ensure full compliance with import permit, customs duties and VAT requirements for clinical material shipments and develop appropriate Supply Chain SOPs to support.
• Establish policies and procedures to support product launch and scalable commercialization efforts.
• Source and select clinical (and future) commercial third-party logistics (3PL) vendors to support Avidity's planned global footprint.

• Identify and communicate any risks to clinical program timelines due to manufacturing delays.
• Develop appropriate supply risk mitigation strategy via inventory planning.

• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
• Establish excellent working relationships within the CMC team, QA, Legal and Finance to reinforce ways to efficiently manage and report on flow of product, information and cash.

Qualifications

• Minimum Bachelor's degree in supply chain, pharmaceutical sciences, engineering, or related field required.

• Minimum of 12 years of pharmaceutical industry experience in supply planning.
• Experience in Clinical and Commercial Supply required, along with strong understanding of cGMP and cGCP regulations.
• Experience working with third-party CMOs manufacturing cGMP clinical supplies.
• Experience with MS Project and Excel at a minimum. Experience with ERP systems a plus (Dynamics 365).
• Knowledge of import/export regulations, including pro-forma invoice generation and global trade compliance.

• Knowledge of cGMP, ICH, FDA, EMA guidelines regarding temperature controlled cold chain shipping requirements.
• Proven track record of effective collaboration with external logistics providers.
• Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.

Avidity is committed to complying with federal, state and local law on employee vaccinations. Job candidates should be aware that full vaccination against COVID-19 may be required in the future. Avidity is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.