Associate Scientist I, Tech Services
Associate Scientist I, Technical Services – Downstream
Gilead Sciences is currently seeking an Associate Scientist I for Biologics Technical Operations to support biologics manufacturing at our Oceanside, CA location as well as manufacturing campaigns at contract manufacturing sites (CMOs).
Specific Responsibilities
- Leads or serves as downstream tech operations representative on cross-functional technical transfer or new product introduction projects both internally and contract manufacturing sites
- Responsible for initiating and directing the implementation of manufacturing changes on multiple projects across multiple production sites.
- Provides on-the-floor technical support as needed across multiple manufacturing sites.
- Writes impact assessments and supports change control, deviations, and CAPA completion.
- Leads the completion of all downstream technical activities for manufacturing through management of internal and external resources.
- Analyzes and identifies risks with processes, technologies and methods.
- Identifies opportunities to improve processes within the business, and provides technical expertise and support to process improvements.
- Monitors process performance by collecting and analyzing process data using statistical
- Supports automation and process validation activities.
- Manages multiple projects/initiatives in parallel.
- May supervise personnel, and act as a mentor to those with less experience and provide
- Acts as an effective and committed team member
- Please note - role will require a minimum of 20% travel, locally and abroad.
Essential Functions
- Leads technical support activities related to maintaining clinical and commercial product supplies through management of internal and external resources.
- Contributes to and leads complex projects across functions, and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost
- Contributes to and leads technical investigations of process deviations and assessment of their impact on product quality. Defines requirements for and reviews master batch records.
- Contributes to user requirement specifications, and provides expert process technical support to utilize and validate new and improved technologies.
- Liaises with manufacturing groups to deliver new and improved drug products and processes.
- Can lead one or more specific components of departmental strategic initiatives.
- Revises, improves or develops new procedures to support clinical and commercial products; writes protocols and reports.
- Designs and executes bench experiments to support internal and external manufacturing initiatives or collaborations with external researchers
- Identifies and introduces new technology and/or methods to the organization, and trains junior staff and/or manufacturing staff on their implementation.
- Provides assessment and selection of equipment and critical materials based upon operational capability and process performance data during scale-up and new process
- Analyzes and identifies risks with processes, technologies and methods, creates a working plan to prevent potential issues.
Education & Experience
- A Bachelor’s Degree in a relevant scientific discipline and a minimum of five (5) years of relevant experience OR a Master’s Degree in a relevant scientific discipline with a minimum of three (3) years of relevant experience.
Knowledge & Skills
- Demonstrates a strong knowledge of large scale protein purification and Good Manufacturing
- Practices (GMPs), and can ensure that processing activities are adherent to compliance. expectations in both clinical and commercial processing environments.
- Exhibits a good working knowledge of regulatory filing requirements and guidance documents.
- Can serve as a subject matter expert on chromatography and filtration (including tangential flow filtration) operations in cGMP environments.
- Familiar with and capable of implementing single use technologies and systems in cGMP
- Experience with viral vector/vaccine manufacturing process is a plus.
- Possesses excellent verbal, written, and interpersonal communication skills.
- Demonstrates strong computer, organizational, and project management skills.
- Candidate should be self-motivated, organized, collaborative and a team player
- Prior experience in MSAT, PD and MFG is preferred.
About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and
commercializes 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.
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