Principal Associate, Quality Control Analytical
- Employer
- Neogene Therapeutics
- Location
- Santa Monica, CA
- Start date
- Aug 31, 2024
View more categoriesView less categories
- Discipline
- Information Technology, Business/Data Analytics, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
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 Summary
We are looking for someone with cell therapy quality control background to join our Quality Control (QC) team. You will contribute to the advancement of our product pipeline by performing QC analytical method qualification, complete sample analysis and other assigned tasks. You will also independently organize 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-hour.
Responsibilities
- Perform flow cytometry, ELISA, cellular cytotoxicity, qPCR, and other analytical assays to promote 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 discussion, document review and investigation.
- Prepare departmental SOPs, technical documents, undertake investigations, review and approvals e.g. OOS, Change Controls, Deviations
- Author and review analytical test results, technical and regulatory documents including analytical study data summaries and reports, analytical method qualification protocols and reports, standard operating procedures (SOP).
- Perform other tasks as requested by supervisor/manager to support Quality.
Education and Experience
- BS 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 in weekend or holidays to support lot release testing.
- Demonstrated ability to take ownership, initiative, and self-accountability.
- Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
- Experience in Cell or Gene Therapy
- Well versed in various analytical techniques Flow cytometry, qPCR, dPCR, cell-based potency and/or ELISA experience.
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 $85,000 to $100,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, 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.
Benefits
- Short-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 Statement
AstraZeneca 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.
Company
Neogene Therapeutics is a global, preclinical stage biotechnology company pioneering the development of next generation, fully individualized engineered T cell therapies for a broad spectrum of cancers.
Our proprietary neoantigen T cell receptor (TCR) discovery and T cell engineering platform identifies TCR genes with specificity for neoantigens – found exclusively on cancer cells as a result of cancer-associated DNA mutations.
Cancer is a genetically individual disease – no two tumors are exactly the same. These variations create neoantigens – unique targets for every tumor. Neogene’s novel approach delivers a tailored T cell therapy containing a unique set of specific TCR genes for each individual patient. Engineered into patient-derived T cells, these TCRs are directed toward neoantigens in tumor cells, with the goal of eliciting strong and durable responses in a variety of solid tumor indications.
We offer the opportunity to join a highly dynamic biotech start-up. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.
- Website
- https://www.neogene.com/
- Location
-
2225 Colorado Avenue
Santa Monica
CA
90404
United States
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