Associate Director of Lab Management and Stability at AstraZeneca in Gaithersburg, Maryland

Job Description:

Introduction to role:



The Associate Director of Lab Management and Stability will be responsible for oversight and coordination of lab investigations, CAPAs, and continuous improvement (CI). This function will also oversee equipment maintenance, sample management, and data integrity. Finally, this role will oversee the design, implementation, and management of stability programs for AZ's commercial cell and gene therapy operations. Included in this role's function will be collaboration with cross-functional teams; ensuring adherence to GMP, pharmacopeial standards, and other regulatory guidelines. This role will additionally lead and develop a team of Quality Control (QC) professionals, providing mentorship and guidance.



Accountabilities:



- Provide development, leadership, and structure regarding investigations, CAPAs, and CI for Quality Control.


- Provide an interface/communication between manufacturing, quality, validation, and relevant functions for Stability, Investigations, and Equipment Maintenance.


- Lead and actively promote continuous improvements in working practices and procedures by liaison with laboratory staff and other functions, as appropriate, to identify focus areas and assist in the resolution of key issues.


- Lead Stability and Lab Management team, with team providing support to broader QC.


- Maintain awareness of current regulatory/industry standards and regulations applicable to QC operations, e.g. relevant pharmacopeia, MCA and FDA guidelines and updates, PDA technical reports, etc.


- Ensure via planning, delegation, and resource management the timely, effective, and compliant output of the laboratories to meet customer (schedule adherence) and regulatory requirements (license to operate).



Essential Skills/Experience:



- Requires a Bachelor's Degree in Microbiology, Biological Sciences or related discipline.


- 8+ years of experience in biopharma, medical device, or pharmaceutical manufacturing.


- 6+ years of experience with Advanced Degree (MS or PhD).


- 2+ years of managerial/supervisory experience.


- Extensive experience in analytical testing within the pharmaceutical or biotechnology industry, Stability experience preferred.


- Experience with Laboratory Investigations and CAPAs.


- Ability to work in a matrix environment.


- Excellent communication skills (with staff, peers and upper management) and ability to develop rapport with other functional leaders to influence decision-making.


- Ability to make effective decisions and do so in the absence of complete information and when under pressure.



Desirable Skills/Experience:



- Cell Therapy Experience


When we put unexpected teams in the same room, we unleash 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.


At AstraZeneca, our work is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first. Our focus on growth and innovation means there are always exciting products to quality assure as we go to market around the world.


Ready to make a difference? Apply now!


The annual base pay (or hourly rate of compensation) for this position ranges from $123,528 - $185,292 USD, Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as 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.


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.