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 seeking a highly motivated Sr Scientist, Quality Control Analytical who will report to the Associate Director of the Quality Control Analytical at the Santa Monica site. This skilled and organized individual will provide management and technical expertise to the QC Analytical laboratory while maintaining open communication channels to meet the needs of the organization.
The Sr Scientist, Quality Control Analytical will partner with Analytical Development to coordinate training, transfer and qualification/validation of new assays in the QC Analytical Laboratory. She/he will be also responsible for timely execution, review, and approval of test results for in-process, bulk, final product, and stability samples. She/he will work closely with the other functional areas to setup or improve GMP workflows to timely execute the QC activities in compliances of regulatory guidance.
The Sr Scientist, Quality Control Analytical will ensure that the QC Analytical laboratory is operating as expected. She/he will partner with Facilities to coordinate QC Analytical equipment and instrument maintenance and calibration. She/he will manage the lab operations and set up proper procedures for lab investigations and GMP validation workflows. The QC Analytical Sr Scientist will be accountable for leading the closure of complex analytical lab investigations.
This role may provide occasional technical and supervisory oversight on weekends and off-hour.
Responsibilities
- Develop and execute method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development or to QC as well as the transfer and validation of methods between manufacturing sites.
- Develop, revise, and review SOPs, qualification/validation protocols and reports.
- Responsible for conducting laboratory investigations, OOS, OOT. Generation of CoAs for product release.
- Draft/review global regulatory submissions.
- Monitor and trend data while assembling reports on product release test. Frequently update stakeholders on trends and implement corrective action plans.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
- Required to build a quality mentality with the team by facilitating the desired 'way of working' through actions, coaching and mentoring.
- Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols.
- Perform a broad variety of basic and moderate complex tests and validations in support of lab operations, including but not limited to flow cytometry, dPCR and other QC assays.
- Record and document all quality control testing activities accurately and in compliance with cGMP regulations and company procedures.
- Perform routine lab maintenance, including equipment qualification/maintenance.
- Monitor and trend data while assembling reports on product release test.
- Frequently update stakeholders on trends and implement corrective action plans.
- Perform other duties as desired.
Education and Experience
- 7+ years in quality control testing, analytical development, or GMPwith BS/BA; 5+ years with MS/MA in biology, Biochemistry, Molecular Biology; 2+ years with PhD
- 1+ years of management experience
- Experience in Cell or Gene Therapy.
- Experience in leading both early phase qualification and late phase validation.
- Flexibility of occasionally working on weekend or holidays to support lot release testing.
- Work experience in a cGMP environment with supervisory and qualification responsibilities.
- Experience authoring and/or reviewing Deviations, Investigations, CAPA and/or Change Control.
- 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
- Identifying, evaluating and closing OOS's and investigations.
- Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
- Familiar with equipment IQ/OQ/PQ in a QC setting.
- Ability to communicate and work in a self-guided manner with scientific/technical personnel.
- Well versed in various analytical techniques such as FACS, ELISAs, PCR, HPLC and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Quality Control, GMPs, bioanalytical method validation.
- Identifying, evaluating and closing OOS's and investigations.
- Knowledge of cell culture techniques.
- Ability to communicate and work in a self-guided manner with scientific/technical personnel.
- Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Excellent interpersonal, verbal, and written communication skills.
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 $125,000 to $149,000. 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.
Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.