CASY-MSCCN Jobs

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

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 of more than 6,300 people 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 18 marketed products that are benefitting 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.

Specific Responsibilities:

• Leads laboratory quality activities for analytical operations, quality control, and contract labs across clinical and commercial partners.

• Conducts or serves as a lead/coordinator of deviations, laboratory investigations, and corrective and preventive action (CAPA) recommendations. May represent QA on Material Review Boards, escalations, and will need to communicate critical events in a timely manner.

• Review and approve stability protocols and reports as well as analytical and stability data in regulatory findings and data generated by and for Gilead Sciences.

• Reviews and approves method validation/method transfer activities from Phase 1 through commercial.

• Reviews and approves master batch records, labels, specifications and other pre-production documents for Gilead product in compliance with FDA and international health agency requirements.

• Reviews executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of Gilead product in support of product disposition.

• Assists in compliance audits as required.

• Maintains electronic records (IQS) and paper archives (lot history records, reports, and logbooks) as needed

• Writes, revises, and reviews standard operating procedures

• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.

• Works directly with contract manufacturers and alliance partners to manage quality related issues with minimal supervision.

• Interacts with key stakeholders such as Formulation and Process Development, and Regulatory Affairs to ensure that Gilead products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).

• Normally receives very little instruction on routine work, general instructions on new assignments.

• Assists in departmental planning activities to ensure that deliverables are provided according to project timelines

Required Skills:

• Strong working knowledge of Quality Systems and cGMP standards

• Strong background in laboratory investigations, deviations, and associated CAPAs

• Background in analytical method validation and method transfer activities

• Experience in pharmaceutical manufacturing and analytical testing

• Experience in an outsourced pharmaceutical manufacturing model and working with CMOs to drive improvement

• Strong problem solving, leadership, and negotiation skills

• An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures

• Must be a critical thinker and can exercise sound judgment in compliance with defined procedures and current industry practices and must recognize deviations from accepted practice

• Ability to work on complex issues where analysis requires an in-depth assessment, consideration of many variables, and potential consequences

• Ability to lead a project team

• Ability to act as a mentor to junior staff

• Excellent attitude with strong verbal, written, and interpersonal communication skills

• Self-starter, able to work independently

• Able to travel infrequently (less than 10%)

Essential Duties and Job Functions:

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

• Participates in developing Standard Operating Procedures to ensure quality objectives are met.

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).

• Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.

• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.

• Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

• May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.

• Participates in the writing of annual product reviews.

• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

• Works with Research and Development during new product start-ups and identifies routine checkpoints for new products and processes.

• May assist with compliance audits as required

• Interfaces with contract manufacturers to address documentation and compliance issues.

• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.

• Normally receives no instruction on routine work, general instructions on new assignments.

Basic Qualifications:

• 6+ years of relevant experience in a GMP environment related field and a BS or BA.

• 4+ years of relevant experience and a MS.

Preferred Qualifications:

• Prior experience in pharmaceutical industry is preferred.

• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.

• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.

• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations

• Demonstrates audit and investigation skills, and report writing skills.

• Demonstrates strong verbal, technical writing and interpersonal skills.

• Demonstrates proficiency in Microsoft Office applications.

The salary range for this position is: $112,030.00 - $144,980.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)

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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after 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 an accommodation.