Getting Hired
Research Associate, Analytical Ops
Getting Hired, Foster City, California, United States, 94420
Overview
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated, attentive, and self-driven candidate to join the Method Validation and Transfer team in Global Small Molecules. The successful candidate will contribute to the method validation of drug substance, drug product intermediate and drug product to support early phase clinical projects. The candidate will have opportunities for career growth through acquisition of new skills, experiences, and GMP knowledge in a fast-paced and resource-rich environment. The ideal candidate is expected to be action oriented and should possess good verbal and written communication and interpersonal skills. Role Summary: Responsibilities
Conducts method validation and transfer experiments with guidance for clinical drug substances and products. Conducts GMP testing for release and stability of clinical drug substances and products using various analytical techniques (e.g. Karl Fisher, Chromatography and Dissolution). Applies knowledge and complies with GMP in daily activities. Performs regulatory filing analytical data verification to ensure data integrity. Conducts experiments for troubleshooting failures/investigations under supervision. Supports method transfer to qualify CMOs/CTLs for release and stability testing. Escalates issues and risks to the manager and stakeholders, as applicable. Basic Qualifications
BS or BA degree in Chemistry, Biology or relevant science/engineering majors with 0-2 years of relevant experience in biotech/pharmaceutical experience. Hands-on laboratory experience required. Preferred Qualifications
Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments. Strong working knowledge of cGMP and quality control (QC). Knowledge in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance. Knowledge in Compliance System (e.g. Veeva). Be an effective communicator of ideas and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment. Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience. Excellent verbal and written communication skills. Salary & Benefits
The salary range for this position is: $82,195.00 - $106,370.00. 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 more information about equal employment opportunity protections, please view the Know Your Rights poster. 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 opinions. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance. Please apply via the Internal Career Opportunities portal in Workday if you are a current Gilead employee or contractor.
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Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated, attentive, and self-driven candidate to join the Method Validation and Transfer team in Global Small Molecules. The successful candidate will contribute to the method validation of drug substance, drug product intermediate and drug product to support early phase clinical projects. The candidate will have opportunities for career growth through acquisition of new skills, experiences, and GMP knowledge in a fast-paced and resource-rich environment. The ideal candidate is expected to be action oriented and should possess good verbal and written communication and interpersonal skills. Role Summary: Responsibilities
Conducts method validation and transfer experiments with guidance for clinical drug substances and products. Conducts GMP testing for release and stability of clinical drug substances and products using various analytical techniques (e.g. Karl Fisher, Chromatography and Dissolution). Applies knowledge and complies with GMP in daily activities. Performs regulatory filing analytical data verification to ensure data integrity. Conducts experiments for troubleshooting failures/investigations under supervision. Supports method transfer to qualify CMOs/CTLs for release and stability testing. Escalates issues and risks to the manager and stakeholders, as applicable. Basic Qualifications
BS or BA degree in Chemistry, Biology or relevant science/engineering majors with 0-2 years of relevant experience in biotech/pharmaceutical experience. Hands-on laboratory experience required. Preferred Qualifications
Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments. Strong working knowledge of cGMP and quality control (QC). Knowledge in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance. Knowledge in Compliance System (e.g. Veeva). Be an effective communicator of ideas and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment. Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience. Excellent verbal and written communication skills. Salary & Benefits
The salary range for this position is: $82,195.00 - $106,370.00. 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 more information about equal employment opportunity protections, please view the Know Your Rights poster. 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 opinions. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance. Please apply via the Internal Career Opportunities portal in Workday if you are a current Gilead employee or contractor.
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