Manufacturing Specialist- Operations Analyst
Manufacturing Specialist- Operations Analyst
United States - California - San Dimas
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.
Role and Responsibilities:
The Manufacturing Specialist plays a key role in the continuous improvement of KPIs and compliance enhancements and will be responsible in the application of cGMP in developing, supporting and advising on critical data analysis (e.g. Oracle, SAP, KRONOS, Workday). The Manufacturing Specialist is key driving for operational excellence and project management applications that align with strategic initiatives.
Specific responsibilities include:
- Serves as team representative on cross-functional projects to support critical manufacturing initiatives
- Plans, executes and tracks a variety of manufacturing projects both internally and in coordination with cross-functional teams (internal and external).
- Uses more complex research techniques and methodologies like Six Sigma and Kaizen to improve process/product quality. Coordinates cross-functional efforts to resolve manufacturing issues in projects, special tasks and excursions.
- May participate in audits to include internal, vendors, contract manufacturers, or APIs.
- Demonstrates proficiency in regulatory affairs and applies knowledge to processes. Implements systems for tracking project progress.
- Writes and/or implements change controls and revisions to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
- Manages, supports, integrates and coordinates implementation of established and new systems (SAP, LES, LES, WERUM)
KNOWLEDGE, EXPERIENCE & SKILLS:
- 6+ years of relevant experience and a BS or BA OR 4+ years of relevant experience and a MS
- Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred.
- Proficient knowledge of Good Manufacturing Practices (GMPs)
- Experience with data analytics tools
- Prior experience in SAP, LES, WERUM, MES, Maximo, Valgenesis, Compliancewire, Trackwise and Veeva preferred. Strong verbal, technical writing and interpersonal skills are required.
- Proficiency in Microsoft Office applications
- Must possess a strong knowledge of the FDA/IMB/HPRA regulatory guidance documents.
- Demonstrated investigation and report writing skills.
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.
For jobs in the United States:
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.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---San-Dimas/Manufacturing-Specialist--Operations-Analyst_R0017957
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