Associate Director Quality Control
We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.
Supervises, motivates and develops direct reports in accordance with the company’s leadership principles. Plans, coordinates and verifies the proper and timely execution of monitoring activities in the production areas and laboratories. Responsible for the preparation and updating of SOPs governing the environmental monitoring program. Trains all people associated with aseptic activities in general Microbiology techniques and aseptic technique. Provides technical expertise and on the floor mentoring for gowning, disinfection and aseptic technique to manufacturing group
Reports to Sr. Director, Quality Control
Location Thousand Oaks, CA
- Coordinates analysts' time, resources, and schedule necessary assays
- Ensures training in specific assays and sampling rotations
- Sets, monitors and evaluates goals and performance
- Develops career paths with analysts
- Recruits temporary and full-time analysts
- Reviews the calibration activities for the measuring instruments used in the environmental monitoring group and inspects the relevant log books within the defined intervals
- Reviews and approves data
- Assists with assay trouble shooting, failure investigations and improving lab systems
- Ensures compliant Environmental Monitoring and Utility Monitoring programs are maintained
- Reviews EM trend data to proactively identify issues
- Performs sampling rotations or assays as necessary
- Ensures timely closure of Alert/Action investigations and exception reports
- Provide SME support on microbiological assays such as Bioburden, Sterility, Endotoxin and Mycoplasma
- Maintains GMP compliance and documentation
- Maintains compliance with legal regulations on occupational safety and health, particularly with regard to hazardous materials
- Implement laboratory policies and procedures
- Drive lean lab operation, 5S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
- Lead special projects and investigations as appropriate
Travel - Travel may be required (up to 20%).
Subject to extended periods of sitting and/or standing in a laboratory environment. Ability to lift up to 50 lbs and to work in BL2 laboratory required.
Skills & Abilities:
- Advanced knowledge of microbiology methods and instruments, as apply to aseptic processing. Including validation experience. Advanced knowledge of GMPs, safety regulations and data integrity.
- Advanced knowledge of GMPs
- Advanced knowledge of FDA and EMEA requirements
- Understanding of EPA and OSHA requirements
- Experience ensuring laboratory KPIs meet compliance requirements
- Experience ensuring all laboratory investigations meet compliance requirements
- Advanced knowledge of root cause investigation principles and troubleshooting techniques
- Application of statistical evaluation of laboratory data
- Advanced understanding of Laboratory applications (e.g., LIMS, SAP, ATLAS etc.)
- Advanced knowledge of problem-solving tools (e.g., SPC, Fishbone diagrams, etc)
- Visual presentation methods & technologies (e.g., design charts, summarize data
- Application of Lean Laboratory principles
- Advanced knowledge of microbiology methods used in the laboratory
- Risk management principles & techniques
- Experience successfully leading and managing complex project with tight timelines
- Able to build strong relationships, influence others to desired goal, mentor others
Professional Experience & Education
- Requires a bachelor’s degree in Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology
- 10 or more years of experience or an equivalent combination of education and experience
- Quality control experience in the pharmaceutical industry supporting cGMP areas, including environmental monitoring experience
- Experience leading people and/or projects with history of achieving results and outstanding outcomes
More About Atara Bio
Now in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.
One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”
The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.
Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).
Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
Working at Atara Bio
People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.
Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.
We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.