Sr. Manager, Outsourcing Manufacturing 9/9/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONAPPLY SPECIFIC 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 manufacturers (CMOs) in assigned projects.
Selects and recommends CMOs for materials and services.
Serves as the point of contact for CDM in the assigned projects.
Prepares and reviews RFPs (request for proposals), challenges proposals received from CMOs/CROs.
Places orders for custom manufactured materials and active pharmaceutical ingredients (APIs).
Monitors material shipments from global CMOs, resolves any related shipment issues while working closely with the Gilead Material Management group.
Investigates and resolves inventory / order discrepancies in a timely manner, follows up on invoicing and ensures on time payment as needed.
Authors Contract Manufacturing Manuals (CMMs), responsible for keeping the document current. Manages FCDM document type and ensures content is current.
Monitors and verifies implementation of Gilead s controlled documents at CXOs partner sites.
Coordinates meetings, participate in teleconferences and face to face meetings with CMOs/CROs, publishes agenda and meeting minutes. Leads the meetings.
Assist in review and revision of departmental SOPs in order to streamline and improve current practices.
Monitors secure transport and GVault transactions; this includes CMO implementation and receipt of formal acknowledgement via Gilead s GDoc and secure transport systems
Manages CMOs on a daily basis, responsible for all interactions with CMO s on the assigned projects.
Works with line manager and outsourcing team to develop systems to streamline current vendor performance assessments system.
Participates in relevant chemistry project meetings to ensure that raw material and API needs are satisfied (i.e. manufactured on time and with the required quality)
Participates in solving issues of high complexity and generation of COGs.
Communicates issues to line manager and project team in a timely manner.
Experience in process chemistry is preferred.
Solid knowledge of regulatory requirements in the US and the EU.
Good understanding of the CMO landscape, knowledge of CMO capabilities and limitations
Project management experience and/or certification is a plus.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Leads the day-to-day activities of a large team of personnel.
Develops specific manufacturing recommendations for coordination of production schedules, environmental concerns, and safety issues.
Responsible for delegating and ensuring completion of personnel management activities, including hiring, training, evaluating and performance review.
Manages maintenance of production equipment.
Interfaces with contract filling sites and ensures availability of required components at contractor sites.
Coordinates production flow from Process Development to Manufacturing.
Ensures all regulatory requirements are met in the Manufacturing Department. Responsible for manufacturing of products, which directly impact budget line for the department.
Supervises and monitors performance of Manufacturing Managers and Team Leaders. Coordinates production schedules based on sales and/or clinical requirements.
Manages cGMP training of all Manufacturing employees.
Ensures manufacturing areas and equipment meet all current GMP and all other regulatory specifications.
Manages transfer of new technology from Process Development to Manufacturing.
Recommends development of practices and policies in manufacturing area. Prepares and recommends to management cost reduction opportunities as related to materials, labor or overhead.
Communicates organizational objectives to managers and team leaders and interprets company policies.
Responsible for driving continuous improvement in all operation processes.
KNOWLEDGE, EXPERIENCE AND SKILLS
Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs)
Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards.
Demonstrates strong computer, organizational, and management skills.
Demonstrates excellent verbal, written and interpersonal communication skills.
Has proven successful experience developing and monitoring budgets and expenditures.
Has proven successful people management experience
Has proven successful experience with manufacturing administration or similar.
10+ years of experience in the pharmaceutical industry and a BS or BA.
8+ years of relevant experience and a MS.
Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred.
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 firstname.lastname@example.org for assistance.
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