Sr. Biologics Engineer II, MS&T (Data Analytics)
Sr. Biologics Engineer II, MS&T (Data Analytics)
United States - New Jersey - Morris Plains
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
Sr. Biologics Engineer II (Data Analytics)
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 has an opportunity for an experienced Senior Biologics Engineer II (Data Analytics) at our biologics facility in Morris Plains, New Jersey. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical data analytics.
- Act as essential partner for project technical teams or other stakeholder groups and provide statistical expertise in all aspects of MS&T bringing the added value of data-driven decisions.
- Ensure full integration of statistics across functions into everyday work as appropriate based on a close and deep partnership with scientists.
- Take full ownership and accountability of all statistical content in a QbD framework. Typical applications include the establishment of strategies and the evaluation of results for process / analytical method development and validation, technical transfers, critical investigations etc.
- Master a broad range of statistical sciences applications, such as linear model, DOE, sample size, multivariate analysis, modelling, simulation, machine learning.
- Lead the organization on the application of statistics by providing training.
- Ensure high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance.
- Manage external and internal collaborations with statistical thought leaders and statistical groups in other functions and divisions. Influence internal policies, guidelines and Standard Operating Procedures (SOPs) to ensure appropriate statistical application and represent the organization on key conferences and advocacy groups in order to influence the external and regulatory environment.
- Provide statistical expertise for all global development in compliance with current ICH / Health Authority, QbD guidelines and SOPs.
- Remain up to date with latest developments in the field of statistics and explore CMC applications for our organization.
- Support improvement of data collection and management to enable quick and reliable data analysis.
Knowledge, Experience & Skills:
- Biotech or pharmaceuticals industry and drug conjugation experience highly desirable.
- Experience with optimization and statistical data analysis tools.
- Preferred degree in Statistics, Mathematics, Computer Science, Bioinformatics or related field, and appropriate years of experience:
- Strong project management and organizational skills.
- Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.
- Excellent troubleshooting skills and ability to solve complex technical issues.
- Understanding of guidelines required by FDA, EMA, and other regulatory bodies.
- Strong interpersonal and communication skills, verbal and written.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- Experience of working in global and agile cultural teams.
- High degree of technical competence and effective communication skills, both oral and written.
- Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.
- Master's degree and 6+ years of relevant work experience; or Bachelor's degree and 8+ years of relevant work experience.
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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 firstname.lastname@example.org 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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