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QC Team Lead
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:
- This is an advanced position requiring significant expertise/specialization in area of work, which may support either QC Chemistry or Microbiology as part of day to day responsibilities.
- Organizes, plans and schedules section operations to minimize delays, while complying with all cGMP and safety regulations.
- Coordinates the team's activities with appropriate groups, working with them to troubleshoot problems and provide solutions.
- Supervises more junior staff, including organizing and prioritizing daily tasks, and performing training.
- Responsible for analytical support for at least one major function within the QC department (e.g. raw materials, in-process, intermediate, finished product, stability testing, stability management) while ensuring compliance of protocols, cGMPs, and safety regulations
- Writes and/or implements changes to controlled documents (e.g., SOPs, Software Specifications, Methods, etc.) as needed.
- Leads investigations and supports continuous improvement initiatives.
- Leads smaller projects taking an active role in resource and output management.
- Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Develops solutions to moderately complex problems and conducts final reviews, batch releases and certificate generation as per defined guidelines.
- Interfaces with contract manufacturers to address quality control and related issues. Demonstrates the ability to clearly and concisely present/ explain tests, analysis and outcomes to multiple audiences.
- Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas.
- Demonstrated success in leading investigations and problem resolution.
- Demonstrates the ability to deliver training programs and mentor junior colleagues.
- Ability to work effectively with cross-functional peers.
- Ability to balance detail orientation with timely achievement of defined objectives.
- Demonstrates effective resource (including people) and project management skills.
Essential Duties and Job Functions:
- Leads assigned group of staff in the QC department.
- Acts as advisor and technical resource to more junior staff.
- Supervises QC personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
- Oversees the daily activities of team, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed. Microbiology
- Responsible for transferring new product support methods/instrumentation and procedures from research-oriented departments to the compliance environment.
- Reviews the work of more junior staff for accuracy and consistency.
- Designs balanced and controlled method and/or instrument validation protocols and maintains the intervals of revalidation for applicable compendial methods.
- Prepares and submits method or equipment/instrument validation reports for review and approval.
- Implements compliance systems relating to new functional operation sections (i.e. design systems and procedures to ensure reproducible performance).
- Orders supplies and assigns expiry to incoming materials, tracks requisitions and reconciles against incoming materials and invoices.
- Arranges for equipment service, calibration, and repair. Chemistry
- Responsible for developing technical solutions for semi routine to moderately complex projects and issues related to the QC Chemistry department.
- Proposes, implements, and qualifies current and new pharmacopoeia methods to improve processes and/or ensure compliance with GMP's and other regulatory requirements.
- Provides QC Chemistry technical expertise and counsel.
- Develops cleaning methods.
- Writes and executes protocols and reports.
- Reviews data and results of testing to ensure compliance to appropriate specifications and protocols. Troubleshoots instrumentation and test methods.
- Evaluates equipment for purchase and performs installations and qualifications of the new instruments. Performs method transfers to/from other organizations.
- May lead or coordinate QC and cross-functional projects.
Knowledge, Experience and Skills:
- Full working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
- Project Management and prioritization skills.
- Audit and Investigation Skills, Report Writing Skills.
- Strong verbal, technical writing and interpersonal skills are required.
- Proficiency in Microsoft Office applications.
- Advanced excel skills for Metric reporting.
- Proficiency in general Microbiology techniques such as gram staining; analyze filtration testing, microbial identification, aseptic technique, and plate streaking technique.
- Proficient in quality control systems, methods and procedures for routine and non-routine analysis of raw materials, intermediates and finished product samples - e.g. solid oral dosage, packaging component testing, raw material and sterile product testing etc
Required Education and Experience
- 6+ years of relevant experience and a BS or BA.
- 4+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred.
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.
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:
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