Associate Director - Biologics Technical Operations
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POST DATE 8/20/2016
END DATE 10/10/2016
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.
Specific responsibilities and skills required for this position:
* Gilead Sciences is seeking an Associate Director for the Biologics Technical Operations group at Gilead s Oceanside, CA facility.
* The qualified candidate will manage a team of process engineers for cell culture and purification operations to support the Gilead Biologics internal and external manufacturing activities.
* Candidate will be responsible for the manufacturing process facility-fit assessments and process transfer activities to Gilead Manufacturing and Contract Manufacturing Organization (CMO) facilities in support of early- and late- stage production of the Gilead Biologics programs.
* Experience with process monitoring, data capture, and process trending; including control charting and statistical process control.
* Strong knowledge in cell culture/upstream and protein purification/downstream mammalian processes to support scale-up and process transfer activities.
* Familiar with clinical and large-scale/commercial manufacturing facilities.
* Responsible for the engineering modifications and retrofit activities at internal and external manufacture sites, as well as remediation of facility-fit issues in support of external manufacture
* Strong understanding of cGMP commercial manufacturing and associated regulatory requirements, including proven experience supporting process and facility/equipment sections of BLA and MAA filings.
* Support late-stage process validation activities for internal and external manufacturing facilities in support of Gilead Biologics programs
* Responsible for the design phase and/or engineering evaluation and improvement of clinical and commercial manufacturing facilities as needed
* Support internal and external quality audits and regulatory inspections
* Extensive experience in facility fit evaluation/remediation and successful technology transfers into internal and contract manufacturing sites
* Responsible for authoring and/or reviewing relevant IND/BLA sections and generating responses to global regulatory agencies
* Routine interactions with internal and external operations, engineering, quality and technical groups
* Routine progress reports and updates addressing ongoing technology transfers and manufacturing campaigns
* Excellent communication and collaboration with support groups, including QA, QC, Manufacturing Operations, Regulatory Affairs, Supply Chain, Engineering, Facilities, Biologics Outsourcing and Biologics Process Development
* Work closely with CMC Project Teams and Regulatory Affairs to aid in the delivery of high quality regulatory submissions.
* At all times, assist with adherence to departmental budgets, timelines and schedules, and performance management requirements established within Gilead Sciences
* Manage interactions with contract manufactures (CMOs)
* Routine travel for this position may be required in support of technology transfers and manufacturing oversight outside of the home location of Oceanside, CA.
ESSENTIAL DUTIES AND JOB FUNCTIONS
* Directs activities of the technical services department to meet company goals including: production schedules, environmental concerns, safety issues.
* Investigates site problems to provide solutions to complex and recurring problems
* Supports technical transfer of manufacturing processes to other facilities including support to external clients/projects.
* Assists in transfer of new technology from Process Development to Manufacturing.
* Supports technical transfer of test methods within Gilead to other locations/operations and provides on-site CMC support
* Assesses feasibility of new improved processes and conducts critical review of data/trends
* Evaluates use of alternate Raw Materials and supports QC on technical problems
* Hires, trains, evaluates, and reviews personnel.
* Ensures technical services areas and equipment meet all current GMP and all other regulatory specifications.
* Determines organizational objectives and interprets company policies.
* Responsible for continuous improvement in all operation processes.
KNOWLEDGE, EXPERIENCE AND SKILLS
* Demonstrates substantial knowledge of industry best practices and trends.
* Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.
* Demonstrates excellent verbal, written, and interpersonal communication skills.
* Demonstrates broad experience across areas such as manufacturing and understanding of parenterals, aseptic and BDS operations.
* Has proven prior people management experience.
* 10+ years of experience in the pharmaceutical industry and a BS or BA.
* 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
* Advanced degree preferred, MS and/or PhD. desired.
* 3 + years in a process engineering role preferred.
* Excellent technical writing and communication skills required
* Experience in a collaborative leadership role across multiple project teams
* Direct experience in authoring and reviewing facility and equipment sections for regulatory filings, preferably in Biologics
* Experience with monoclonal antibody processes through development, clinical and commercial scales is required
* Demonstrates substantial knowledge of industry best practices and trends
* Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums
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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