Associate Manager - Biologics Analytical Outsourcing
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POST DATE 9/7/2016
END DATE 11/18/2016
Gilead Sciences, Inc
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 biologics development group is experiencing a period of rapid growth and investment, and is currently seeking an Associate Manager on Biologics Outsourcing team at Oceanside, CA site. This role will work closely with more senior staff to support various aspects of outsourced R&D activities related to biologics analytical and process development efforts, including planning and financial tracking, contract establishment, work order and purchase order generation, and timeline and deliverable monitoring. This individual will assist in monitoring the organization s progress against their plan and forecast (Latest Estimate), and for developing and initiating appropriate interventions with key stakeholders to ensure the financial plan remains on track.
* Primarily manages the quotes, Work Orders and financials associated with invoicing, of CROs/CMOs that conduct analytical and process development activities.
* Collaborates with key stakeholders at Foster City and Oceanside sites to evaluate and on-board CXOs.
* Assists with establishment of legal contracts (CDA, MLSA, etc.), Work Orders and Purchase Orders in collaboration with internal Subject Matter Experts and Legal.
* In collaboration with key stakeholders, manages execution and completion of project deliverables within agreed upon timeline and in compliance with legal contracts and agreements.
* Assists with evaluation and development of business tools and business processes to track project financials, Work Orders, Purchase Orders, and invoices.
* Provides regular financial updates based on the current budget and project activities.
* Ensures applicable activities at CXOs are in alignment with contracts, and needs of key stakeholders.
* Communicates timely and effectively with key stakeholders and external CXOs to ensure that work is completed on-time.
- Primarily works with key stakeholders to manage business relationships and deliverables associated with CXOs conducting analytical and process development activities for Gilead
- Collaborates and establishes regular meetings with key stakeholders to ensure outsourced needs are met
- Assists with onboarding of CXOs including initiating applicable contracts, Work Orders and Purchase Orders
- Maintains outsourced project timelines; evaluates progress against established dates
- Collaborates with key stakeholders to prioritize activities according to project needs
- Maintains oversight of financials and project deliverables associated with outsourced development activities.
- Organizes and participates in teleconferences and face-to-face meetings with CXOs; works closely with Gilead teams to establish agenda, and keep track of key decisions
- Monitors CXOs performance and project progress and provides timely updates to key stakeholders
- Proactively communicates issues, project changes to key stakeholders and facilitates timely discussion and resolution
- Maintains and updates documentation and timelines to accurately reflect the status of the outsourced activities
Travel required for role - 10%
ESSENTIAL DUTIES AND JOB FUNCTIONS
Manages functions related to new and on-going clinical trials, including Gilead, investigator or/and collaborator sponsored trials.
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.
Must be willing to travel 10%
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 :