Manager, Quality Control Data Review Morris Plains, NJ
Manager, Quality Control Data Review Morris Plains, NJ
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
Essential Duties and Job Functions:
- Supports cGMP release and stability testing of product, method transfer and validation of QC methods. Maintains laboratories in a state of GMP readiness.
- Manages QC staff responsible for the day to day data review function of QC testing of biopharmaceutical in process, intermediate, bulk drug substance and drug product, provides leadership and manages performance.
- Reviews cGMP data generated during testing to support product release, stability and facilities monitoring using HPLC, UPLC, Capillary Electrophoresis, micro and wet chemistry methods.
- Ensures that standards for documentation and comply with SOPs (QC methods and Good Documentation Practices) and industry standards.
- Review laboratory logbooks, labeling and other documentation to ensure conformations with SOPs and industry guidelines.
- Provides technical support for monitoring and evaluating the performance of analytical methods to demonstrate ongoing method suitability.
- Compile and summarize analytical and micro raw data in various physical and electronic report formats.
- Experience with deviations, change controls and CAPA's.
- Reviews raw data, protocols, analytical reports and certificates of analysis.
- Experience with environmental monitoring data.
- Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute testing.
- Participates in compliance-focused teams working towards the goal of continuous improvement of laboratory documentation practices.
- May coordinate and track progress of analytical testing internally or at CROs.
- Maintains QC laboratory metrics.
- Ability to establish robust QC systems.
- May participate in regulatory agency audits and inspections
Essential Education, Experience & Skills:
- M.S. degree in Biochemistry, Chemistry, Molecular Biology or a related field, and 8+ years relevant experience or B.S. degree and 10+ years of relevant GMP lab experience with biotherapeutics.
- Multiple years of experience reviewing pharmaceutical data in a GMP-regulated QC laboratory.
- Knowledge of QC laboratory test procedures, cGMP requirements, ICH/USFDA guidelines, USP Compendial methods, raw material analysis, method validation guidelines, method transfers, in process testing, finished products, and stability testing.
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
- Familiarity with regulatory guidance documents from FDA, EMEA and ICH.
- Ability to operate independently where appropriate, yet escalate issues as appropriate, establish effective cross functional working relationships.
- Strong attention to detail is essential. Well-developed organizational, interpersonal communications, writing, and strong listening skills are required.
- Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles.
- Must be able to recognize the impact beyond a single site, project or collaboration.
- Must have strong verbal, technical writing and presentation skills.
- Ability to establish and maintain laboratory metrics.
- Must have expert authorship of technical documents.
- Works well in collaboration with other teams.
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards.
Preferred Experience & Skills:
- 5 years of QC laboratory experience is preferred.
- Direct experience with QC laboratory systems is a plus.
- Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred.
- Experience with HPLC / UPLC, spectrophotometers, capillary electrophoresis, microbiological methods and compendial methods is preferred
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 firstname.lastname@example.org 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.
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