Planner, Clinical Supply Management
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POST DATE 9/2/2016
END DATE 1/13/2017
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
The GMP Shipments Coordinator in the Clinical Supply Management Organization should serve as a
-Strong technical resource and should plan and execute the shipments with enthusiasm and resolve in this fast-paced organization.
-Work through ambiguity, problem solve and collaborate with key stakeholders to ensure the timely processing of shipments needed to support the ongoing demands of the clinical programs.
-This position collaborates closely with other members of Clinical Supply Management as well with all depot contacts.
-Additionally, she or he will work closely with other members of Process Development Manufacturing (PDM) such as those groups responsible for Active Pharmaceutical Ingredient and Bulk Drug Substance in order to meet project deliverables, solve business problems and create competitive advantage.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Primary responsibilities include:
Process high volume Drug Shipment Requests in ERP system
Identify system integration issues and fix sales orders
Initiate system UAT items and perform system UATs
Generate Material Transfer Requests per internal and/or external requests
Obtain required approval for GMP shipments
Generate proforma invoice for international shipments
Set up shipment pick up and /or delivery arrangement with carrier
Coordinate shipping/receiving with CMOs/3PLs
Complete inventory transactions in ERP system
Monitor shipment status throughout the shipment
Contact Customs/FDA/USDA agents to resolve clearance issues
12. Maintain accurate and detailed shipment records
13. Initiate Shipping Incident Report if needed
Coordinate with Commercial Supply Chain in sourcing API for clinical use
Perform monthly GMP inventory reconciliation and follow up disposal requests
Provide carrier s service and charges trending and evaluation
Help to monitor clinical trials by generating IXRs report and identifying depot/site inventory risk
Continuous evaluate order management processes to identify gaps and enhancement areas
Supports clinical material supply and materials management operational tasks related to on-going and new clinical trials.
Coordinates and monitors daily clinical drug shipments at various contract depots.
Monitors clinical shipments to ensure timely deliveries and resolve any shipping related issues.
Enters clinical supply information in GILDA including part number, lot number, depot location and quantities.
Coordinates drug returns for re-distribution and for disposal activities with contract depots.
Reviews inventory report for quantity, lot status, expiration dates. Rebalances depot inventories when needed.
Investigates and resolves inventory discrepancies in a timely manner.
Coordinates domestic and international shipments to ensure Gilead SOPs are followed at contractor facilities.
Completes daily inventory transactions including stock transfers, sales orders, work orders, inventory adjustments and disposals.
Reviews and revises departmental SOPs to streamline and to improve current practices.
Excellent verbal, written, and interpersonal communication and skills are required.
Excellent collaboration and influencing skills are required
Should have basic knowledge of GMP and GDP requirements
Should have basic knowledge of international trade
Strong computer skills (especially excel skills) and strong organizational skills required
Prior experience and prior knowledge of a cGMP related industry (e.g. biopharmaceutical) is highly preferred
KNOWLEDGE, EXPERIENCE AND SKILLS
2+ years of relevant experience and a Bachelor degree
1+ year of relevant experience and a Master degree.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, view the EEO is the Law poster at :