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Associate Director, Raw Materials

Location Gaithersburg, Maryland, United States Rockville, Maryland, United States Job ID R-204607 Date posted 09/07/2024

Introduction to Role:

Are you ready to pioneer a Lean mindset to drive greater quality and safety? As the Associate Director of Raw Materials, you will be responsible for overseeing the raw material testing management and associated control processes within our Operations team. This includes method development, validation, and implementing strategies for testing raw materials. You will collaborate with cross-functional teams to establish testing specifications and requirements for raw materials, manage the testing laboratory, and ensure adherence to GMP, pharmacopeial standards, and other regulatory guidelines. You will also lead investigations into raw material quality issues and implement corrective and preventive action to mitigate risks.

Accountabilities:

In this role, you will lead and develop a team of raw material professionals, providing mentorship and guidance. You will be the interface between manufacturing, quality, and relevant functions for timely testing and release of materials. You will actively promote continuous improvements in working practices and procedures, maintain awareness of current regulatory/industry standards and regulations applicable to QC operations, and ensure the timely, effective, and compliant output of the laboratories to meet customer and regulatory requirements.

Essential Skills/Experience:

- Lead QC Raw Material Testing team

- Provide development, leadership, and structure in creation of specifications, testing parameters, and relevant governing documents

- Maintain awareness of current regulatory/industry standards and regulations applicable to QC operations

- 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, with a focus on raw materials

- In-depth knowledge of analytical method development, validation, and troubleshooting

- Ability to work in a matrix environment

- Excellent communication skills

- 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, we are leading our Operations function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients. We are inspiring and credible leaders, ensuring everyone on our site has a platform and opportunity to speak up and share their ideas. We are the champions of Lean, ensuring our teams understand and embody the benefits it can bring. Our work helps give people with diseases a fighting chance. Every day is a challenge but that's what keeps us going.

Ready to make a difference? Apply today!

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.

10000093 E QAMM

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.