Neogene Therapeutics
Manager, Quality Control Analytical
Neogene Therapeutics, Santa Monica, California, United States, 90403
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position SummaryWe are seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by performing QC analytical method qualification, executing sample analysis, and other assigned tasks. You will also be expected to independently organize, analyze and present results and conclusions. You will ensure that the QC Analytical laboratory is operating as expected.This role may provide occasional technical and supervisory oversight on weekends and off-hours.
ResponsibilitiesPerform flow cytometry, ELISA, cellular cytotoxicity, qPCR, and other analytical assays to enable the release testing and stability monitoring of cell therapy products and in-process samples.Support analytical method development, qualification, and technical transfer from Analytical Development.Support routine analytical activities; occasionally act as a subject matter expert in technical discussions, document review, and investigation.Prepare departmental SOPs, technical documents, undertake investigations, review and approvals e.g. OOS, Change Controls, Deviations.Author and/or review analytical test results, technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method qualification protocols and reports, standard operating procedures (SOP).Perform other duties as requested by supervisor/manager to support Quality.
Education and ExperienceBS or MS in biological sciences or a related field is required.4+ years of relevant experience in Pharmaceutical or Biotechnology industry.Flexibility of occasionally working on weekends or holidays to support lot release testing.Demonstrated ability to take ownership, initiative, and self-accountability.Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.Attention to detail and quick learning/application of concepts and information.Knowledge of cell culture techniques and proficient in MS Word, Excel, PowerPoint, and other applications.Ability to communicate and work in a self-guided manner with scientific/technical personnel.
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $118,399 to $130,239. However, base pay offered may vary depending on multiple individualized factors, including market location and job-related experience. If hired, the employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
BenefitsShort-term incentive bonus opportunity.Equity-based long-term incentive program.401(k) plan.Paid vacation and holidays; paid leaves.Health benefits including medical, prescription drug, dental, and vision coverage.
DE&I StatementAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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Position SummaryWe are seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by performing QC analytical method qualification, executing sample analysis, and other assigned tasks. You will also be expected to independently organize, analyze and present results and conclusions. You will ensure that the QC Analytical laboratory is operating as expected.This role may provide occasional technical and supervisory oversight on weekends and off-hours.
ResponsibilitiesPerform flow cytometry, ELISA, cellular cytotoxicity, qPCR, and other analytical assays to enable the release testing and stability monitoring of cell therapy products and in-process samples.Support analytical method development, qualification, and technical transfer from Analytical Development.Support routine analytical activities; occasionally act as a subject matter expert in technical discussions, document review, and investigation.Prepare departmental SOPs, technical documents, undertake investigations, review and approvals e.g. OOS, Change Controls, Deviations.Author and/or review analytical test results, technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method qualification protocols and reports, standard operating procedures (SOP).Perform other duties as requested by supervisor/manager to support Quality.
Education and ExperienceBS or MS in biological sciences or a related field is required.4+ years of relevant experience in Pharmaceutical or Biotechnology industry.Flexibility of occasionally working on weekends or holidays to support lot release testing.Demonstrated ability to take ownership, initiative, and self-accountability.Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.Attention to detail and quick learning/application of concepts and information.Knowledge of cell culture techniques and proficient in MS Word, Excel, PowerPoint, and other applications.Ability to communicate and work in a self-guided manner with scientific/technical personnel.
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $118,399 to $130,239. However, base pay offered may vary depending on multiple individualized factors, including market location and job-related experience. If hired, the employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
BenefitsShort-term incentive bonus opportunity.Equity-based long-term incentive program.401(k) plan.Paid vacation and holidays; paid leaves.Health benefits including medical, prescription drug, dental, and vision coverage.
DE&I StatementAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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