Gilead
Scientist, Purification Process Development - Pivotal & Commercial Biologics
Gilead, San Mateo, California, United States, 94404
Scientist, Purification Process Development - Pivotal And Commercial Biologics
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer
working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As the Scientist, Purification Process Development - Pivotal and Commercial Biologics, you are responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. In addition, this role is expected to lead/support projects for purification technology development, platform process evolution, and support of regulatory filings. We are seeking a highly motivated, team-oriented individual to support downstream process development for our rapidly growing biologics pipeline. Key Responsibilities: Demonstrates hands-on technical leadership of all aspects of purification process development including chromatography, TFF, and depth filtration Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis Responsible for technology transfer to manufacturing facility and provide technical input and support during manufacturing of drug substances Author or review GMP or non-GMP technical documentation (development reports, process description, batch records, etc) Author and review CMC related regulatory sections Demonstrates technical proficiency and scientific creativity in improving platform technology Demonstrates ability in communicating ideas, project strategies and results to team members across functional roles/departments Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer Help to establish and maintain a state-of-the-art purification lab Participate in cross functional initiatives as needed Adhere to department budget and all training, compliance, and safety requirements Basic Qualifications: Ph.D. and 0-2 years of experience in a relevant scientific discipline (biochemistry, bioengineering, chemical engineering, chemistry, etc) M.S. with 4+ years or BS with 6+ years' experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering) Preferred Qualifications: Hands-on experience of protein purification, thorough understanding of chromatography and familiarization of AKTA are required Broad understanding of downstream development and scale up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal is preferred Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities Working knowledge of lab automation, high throughput screening, and mechanistic modeling Demonstrated ability to collaborate and influence cross-functionally Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire) Excellent communication skills and strong interpersonal skills are desirable Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $146,540.00 - $189,640.00. 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. 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.
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer
working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As the Scientist, Purification Process Development - Pivotal and Commercial Biologics, you are responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases. In addition, this role is expected to lead/support projects for purification technology development, platform process evolution, and support of regulatory filings. We are seeking a highly motivated, team-oriented individual to support downstream process development for our rapidly growing biologics pipeline. Key Responsibilities: Demonstrates hands-on technical leadership of all aspects of purification process development including chromatography, TFF, and depth filtration Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis Responsible for technology transfer to manufacturing facility and provide technical input and support during manufacturing of drug substances Author or review GMP or non-GMP technical documentation (development reports, process description, batch records, etc) Author and review CMC related regulatory sections Demonstrates technical proficiency and scientific creativity in improving platform technology Demonstrates ability in communicating ideas, project strategies and results to team members across functional roles/departments Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer Help to establish and maintain a state-of-the-art purification lab Participate in cross functional initiatives as needed Adhere to department budget and all training, compliance, and safety requirements Basic Qualifications: Ph.D. and 0-2 years of experience in a relevant scientific discipline (biochemistry, bioengineering, chemical engineering, chemistry, etc) M.S. with 4+ years or BS with 6+ years' experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering) Preferred Qualifications: Hands-on experience of protein purification, thorough understanding of chromatography and familiarization of AKTA are required Broad understanding of downstream development and scale up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal is preferred Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities Working knowledge of lab automation, high throughput screening, and mechanistic modeling Demonstrated ability to collaborate and influence cross-functionally Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire) Excellent communication skills and strong interpersonal skills are desirable Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $146,540.00 - $189,640.00. 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. 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.