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Supply Chain Specialist

Day One Biopharmaceuticals

Day One Biopharmaceuticals

Operations
Sterling, VA, USA · Remote
Posted on Thursday, May 30, 2024
SUPPLY CHAIN SPECIALIST
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.
POSITION SUMMARY:
The Supply Chain Specialist role will report to the Associate Director, Supply Chain and will support all stages of the clinical trial from start up through closeout.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Ensure timely provision of packed and labeled investigational medicinal product (IMP) by coordinating shipping and logistics activities including management of shipments of clinical supplies between storage depots.
· Maintain reporting for inventory on-hand, consumption, movements, lot and expiry tracking for all locations where IMP inventory is stored.
· Understand, maintain, and troubleshoot the clinical supplies management functionality of IRT systems.
· Monitor clinical supply inventory levels at storage depots and interface with Clinical Operations and CMC team to maintain continuous supply availability.
· Communicate and collaborate with Clinical Operations on routine basis to understand the current and future scope clinical studies and convey the clinical supplies need to CMC for the purpose of planning future manufacturing, packaging, and labeling. Experience in use of related software tools is expected.
· Execute supply and inventory plans and tracks production schedules for clinical trial materials.
· Support outsourcing to external vendors (Contract Manufacturing Organizations (CMOs), Contract Clinical Distributors (CCDs) and Interactive Response Technology (IRT) systems) to ensure that labeling, packaging, and shipping of IMP in compliance with company SOP and applicable regulations through direct communication with the vendors.
· Participate in development of approvals of technical documents such as clinical label text, IRT User Manuals, and Pharmacy Manuals
· Generation and or review of procedures as applicable to clinical supply chain operations.
· Plan and lead the logistics from production through packaging/labelling, and distribution of clinical and commercial product.
· Create and implement tools and processes to support production planning with accurate and timely information.
· Assist in archiving of clinical supply documents via eTMF
QUALIFICATIONS
· BA or BS in a Science or Logistics field or equivalent experience in clinical supply
· Previous experience in the clinical supplies field required. Minimum 2 years clinical supplies experience preferred.
· Must be able to achieve deliverables with high precision.
· Ability to work independently on projects within a team-oriented environment.
· Innovative thinker with ability to solve complex problems.
· Knowledgeable and compliant to regulations and requirements for functioning under GMP, GDP, and GCP’s.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
COMPENSATION AND BENEFITS
The salary range for this position is $90,000 - $100,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
DISCLAIMER
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.