Associate Scientist I Tech Ops Manufacturing Tech Sciences, Oceanside, CA
Associate Scientist I Tech Ops Manufacturing Tech Sciences, Oceanside, CA
United States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Associate Scientist I - Tech Ops - Manufacturing Tech Sciences
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 matter, 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 Biologics Technical Operations to support biologics manufacturing at our Oceanside, CA location as well as manufacturing campaigns at contract manufacturing sites (CMOs).
Specific Responsibilities and Skills:
- Leads or serves as downstream tech operations representative on cross-functional technical transfer or new product introduction projects both internally and contract manufacturing sites (CMOs).
- 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 tools.
- Supports automation and process validation activities.
- Supports multiple projects/initiatives in parallel.
- Acts as a mentor to those with less experience and provide training
- Acts as an effective and committed team member
- Please note - role will require a minimum of 20% travel, locally and abroad.
- 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 requirements.
- 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.
- 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 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 introduction.
- Analyzes and identifies risks with processes, technologies and methods, creates a working plan to prevent potential issues.
Knowledge, Experience, and Skills:
- 5+ years of relevant experience and a BS degree in a relevant scientific discipline.
- 4+ years of relevant experience and an MS degree in a relevant scientific discipline.
- 1+ years of relevant experience and a PhD degree in a relevant scientific discipline.
- 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 environments
- 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.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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