Associate Scientist I, Cell Culture Manufacturing Technical Sciences
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POST DATE 8/16/2016
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.
Gilead Sciences is currently seeking an Associate Scientist I for the Manufacturing Tech Sciences team to support Biologics Manufacturing and Technical Operations at our Oceanside, CA location.
Specific Responsibilities and Skills:
* Provides technical expertise for internal and external manufacturing, including travel to Gilead Biologics technology transfers and in-plant support.
* Provides manufacturing floor support for internal clinical cell culture production, including daily communication of cell culture unit operations, process monitoring, and late-stage process verification.
* Provides technical support for the implementation and validation of new and improved processes, and contributes to the user requirement specification.
* Investigates process deviations, escalates out-of-trend performance, performs impact assessments on product quality.
* Defines requirements for and reviews master batch records prior to release approval by manager.
* Liaises with manufacturing groups to deliver new and improved drug products and processes.
* Works closely with the process development team to support the process and facility fit technology transfers for external manufacturing.
* Supports and work closely with the Gilead pilot plant team for non-clinical manufacturing and scale-down runs for supporting clinical manufacturing.
* Authors, edits, and provides input for the manufacturing batch records, process SOPs, validation protocols, and manufacturing reports.
* Provides technical input for process characterization and FMEA analysis supporting late stage manufacturing.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Contributes to the completion of all technical support activities related to maintaining commercial product supplies through management of internal and external resources.
Contributes to processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.
Contributes to technical investigations of process deviations, and assessment of their impact on product quality. Defines requirements for, and reviews master batch records prior to release approval by manager.
Contributes to the user requirement specification, and provides process technical support to the utilization and validation of new and improved.
Liaises with manufacturing groups to deliver new and improved drug products and processes.
Interfaces with contract manufacturers to address standard documentation and compliance issues.
Can lead one or more specific components of departmental strategic initiatives. Focuses on a specific area of responsibility or specialization such as a new production process, specific technology in lab or new product release.
Performs investigations as required to support commercial products.
Revises, improves or develops new methods to support commercial products; writes protocols and reports.
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Provides high-level analytical support for one or more major functions within the department.
May provide technical guidance and training to team members.
KNOWLEDGE, EXPERIENCE AND SKILLS
Demonstrates investigation and report writing skills.
Demonstrates strong verbal, technical writing and interpersonal skills.
Demonstrates proficiency in Microsoft Office applications.
Demonstrates knowledge of regulatory guidance documents (i.e. SUPAC, PACPAC).
5+ years of relevant experience and BS in a relevant scientific discipline.
4+ years of relevant experience and an MS in a relevant scientific discipline.
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.
For more information about equal employment opportunity protections, view the EEO is the Law poster at :