Associate Manager, Outsourced Manufacturing
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POST DATE 9/13/2016
END DATE 10/23/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
With the commitment and drive you bring to the PDM workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Actively manages Contract Manufacturing Organizations (CMO s) for their assigned projects.
Ensures all regulatory requirements are met in the manufacturing of bulk API.
Ensures availability of raw materials at contract manufacturing sites.
Manages transfer of new technology from Process Development to contract manufacturing sites.
Assists in the coordination and execution of departmental quality, business and technical audits of API and raw material manufacturing facilities.
Coordinates communication between CMOs and Gilead functional areas. May supervise at least one direct report.
Works on highly complex problems requiring evaluations of multiple factors before resolution can be reached.
Exercises judgment within defined practices and policies.
Effectively interacts with senior management.
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases
Must be able to interface with contract sites to ensure production flows smoothly and that all Gilead requirements are met.
Must be able to identify creative solutions to diversified challenges within the regulated environment.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Through subordinates, manages functions related to new and on-going clinical trials, including Gilead, investigator or/and collaborator sponsored trials.
Works closely with Drug Product Development to identify API requirements.
Purchases comparator s drugs, APIs, intermediates and starting materials.
Manages domestic and international shipments of clinical drug products and ensures Gilead SOPs are followed by contractor facilities...
May complete inventory transactions in company wide systems, including BP setup, inventory receipts, stock transfers, work orders, inventory adjustments, item master, etc.
Maintains accurate inventories at contract facilities/warehouses, resolves inventory discrepancies in a timely manner and monitors expiring clinical drug products for disposal.
Works on special projects, non-routine problems, meets mfg. schedules and/or resolves technical problems.
Frequently interacts with functional peer group managers.
Provide supervision, training, and guidance to other department personnel.
In depth understanding and application of principles, concepts, practices, and standards along with an in depth knowledge of industry practices.
Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation.
Strong negotiation skills.
Exceptional verbal and written communication skills.
Sound organizational and time management skills.
Ability to effectively manage multiple priorities.
Working knowledge of GMPs and associated regulations.
Ability to interact effectively with senior management.
KNOWLEDGE, EXPERIENCE AND SKILLS
7+ years of relevant experience and a BA or BS degree.
A MA/MBA degree can be substituted for 2 years of relevant experience.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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.
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