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Biologics Engineer I, MS&T - Continued Process Verification (CPV) - 8,000 Sign On

Employer
Gilead Sciences, Inc.
Location
Foster City
Salary
See job description.
Closing date
Oct 21, 2021

View more

Discipline
Health Sciences, Medicinal/Pharmaceutical Chemistry
Position Type
Full Time
Job Type
Manager
Organization Type
All Industry, Pharma


Biologics Engineer I, MS&T - Continued Process Verification (CPV) - 8,000 Sign On
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

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Biologics Engineer I - Continued Process Verification (CPV) - $8,000* Sign On

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 Biologics Engineer I (CPV) at our biologics facility in Morris Plains, New Jersey. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical data analytics.

Job Responsibilities:
  • Represent Manufacturing Sciences and Technology (MS&T) as a Continued Process Verification (CPV) Subject Matter Expert (SME) to coordinate multi-functional activities relating to CPV data collection, document generation and CPV investigations.
  • Participate in cross functional business and scientific initiatives as the MS&T representative, and effectively collaborate and influence cross-functional partners to support MS&T objectives.
  • Support the CPV activities ensuring strategy design is in alignment with business needs, regional & global regulatory compliance.
  • Review and approve technical documentation including protocols, technical investigations and reports related to CPV.
  • Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.
  • Partnering with cross functional Departments, support investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place.
  • Ensure high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance.
  • You support improvement of data collection and management to enable quick and reliable data analysis.


Knowledge & Skills:
  • Experience with statistical data analysis tools.
  • 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.


Specific Education & Experience Requirements:
  • Preferred degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field, and appropriate years of experience.
  • MS/BS and 2+ years of relevant work experience.
  • Extensive experience in biotech or pharmaceuticals industry and drug conjugation experience highly desirable.


*This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue.

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 careers@gilead.com opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2478655&targetURL=mailto:careers@gilead.com">careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b

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.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---New-Jersey---Morris-Plains/Biologics-Engineer-I--MS-T---Continued-Process-Verification--CPV-_R0021962





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