Associate II, Outsourced Manufacturing
Associate II, Outsourced Manufacturing
United States - California - Foster City
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
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.
The Associate II of Outsourced Manufacturing will play an important role within the Chemical Development and Manufacturing (CDM) organization to drive projects to progress as planned, at both clinical development and commercial manufacturing stages and ensure delivery of clinical and/or commercial materials (API drug substance, intermediates and raw materials) on time, in acceptable quality and in full compliance. They will also be responsible for financial planning/tracking, contract establishment, work order/purchase order generation, timeline/deliverable monitoring and project management. The Associate II will have the opportunity to work with and learn from colleagues across Gilead (Process Chemistry, Regulatory, Formulations, Analytical, Quality, Supply Chain, etc.), as well as multiple CRO and CMO organizations.
- In collaboration with key stakeholders, manages execution and completion of project deliverables within established timelines and in compliance with legal contracts and agreements
- Ensures all related manufacturing conforms to the appropriate regulations (GMP, ICH, QA, Regulatory, etc.)
- Supports technical transfer activities to new supplier sites
- Negotiates manufacturing schedules and prices with external suppliers
- Reviews contractor documentation including master batch records, specifications, deviations and change controls for GMP compliance and alignment with Gilead standards
- Identifies and purchases custom raw materials, reagents, and other services necessary for the supply of drug substances
- Manages logistics activities for outsourced materials such as warehousing, transportation, customs clearance and invoicing
- Frequently interacts with other functional peer group managers within Gilead and CMOs to support process development or manufacturing activities
- Organizes and participates in teleconferences and face-to-face meetings with CXOs; works closely with Gilead teams to establish agenda and keep track of key decisions and action items
- Proactively communicates issues, project changes to key stakeholders, and facilitates timely discussion and resolution
- Maintains and updates documentation and timelines to accurately reflect the status of the outsourced activities
- Works on special and non-routine projects focused on continuous improvement, teamwork/teambuilding, and operational excellence
Skills and Experience
- 4+ years of progressively responsible experience in a related field, including process development, manufacturing, or outsourcing in the pharmaceutical industry and a BA or BS degree in Chemistry or Engineering fields
- A MA/MS/MBA degree can be substituted for 2 years of relevant experience.
- Basic understanding of synthetic chemistry and/or pharmaceutical process development
- Ability to effectively manage multiple priorities
- Working knowledge of GMPs and associated regulations
- Sound organizational and time management skills
- Strong presentation, oral and written communication skills
- Ability to interact effectively with senior management
- Ability to collaborate with cross functional teams
- Ability to work under uncertainty and to resolve conflict in a constructive manner
- Ability to solve moderately complex problems through ingenuity and collaboration with SMEs and other key stakeholders
- Ability to work in a fast-paced environment
- This position may require domestic and international travel time up to 10%
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/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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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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