Takeda Pharmaceuticals Manager, Clinical Supply Chain Operations in Lexington, Massachusetts
Job/Position: Manager, Clinical Supply Chain Operations
Under the direction of the Clinical Supplies Director, as the Clinical Supplies Project Lead you will be responsible for Clinical Supply delivery in support of Takeda R&D Global Clinical Trials and other supportive research or development needs, and work with both internal and external customers and suppliers in order to develop and communicate project budgets and plansand to ensure that all project objectives are met in a timely and compliant manner.
You will lead areas of responsibility include coordination and management of the procurement, packaging, labeling, distribution return, reconciliation, anddestruction activities of Investigational Medicinal Products.
You will lead Global Clinical Supply Chain group initiatives including the active participation of the study oversight process for Global Clinical Supply Chain activities for the Takeda Trial Delivery Operation Model (TDOM).
Work with Clinical Supplies Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines and budgets.
Utilize the Smart Supplies Clinical Supplies Management Database (PMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
Provide input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality.
Interface with Clinical Supplies Technologies Team to understand IRT standards and PMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
Interface with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of IMP for shipment to sites.
Interface with Product Development group to ensure that trial supplies are appropriately supported and that appropriate stability programs are in-progress, and/or appropriate expiry dating exists.
Work closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.
Work with Clinical Supply Specialists to manage and troubleshoot shipment requests, drug returns, PMD, and IRT processes. Works with them to ensure creation and maintenance of Clinical Supply IMP documentation and product specification files (where required) according to established procedures and to manage IMP inventory for projects assigned.
Coordinate primary and secondary packaging, labeling, testing, distribution, return drug management activities with contract providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Takeda.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Degree in Pharmacy, other scientific/technical degree or significant job related experience.
5-8 years relevant Pharmaceutical Industry and/or Contract Provider experience is preferred.
Experience with Medical Devices a plus.
Strong understanding of cGMP requirements
Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus
Base Salary Range: $102,200 -$146,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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