Associate Director, Raw Materials Testing

Job Title: Associate Director, Raw Materials Testing

Introduction to role:
Are you ready to lead the charge in raw materials testing and control processes? As the Associate Director of Raw Materials Testing, you'll be at the forefront of establishing and overseeing our raw materials laboratory. Your role will encompass method development, validation, and the strategic implementation of testing techniques and instrumentation. Collaborate with cross-functional teams to set testing specifications and requirements, ensuring adherence to GMP, pharmacopeial standards, and regulatory guidelines. You'll lead investigations into raw material quality issues, implementing corrective actions to mitigate risks. Additionally, you'll develop and mentor a team of raw material professionals, guiding them to success.

Accountabilities:

• Oversight of raw materials testing processes and controls, ensuring GMP production materials are fit for use.

• Lead a high-performing raw materials testing team, including management of staffing, training, performance, and development.

• Provide development, leadership, and structure in the creation of specifications, testing parameters, and relevant governing documents.

• Facilitate communication between manufacturing, quality, and relevant functions for timely testing and release of materials.

• Promote continuous improvements in working practices and procedures by liaising with laboratory staff and other functions to identify focus areas and resolve key issues.

• Maintain awareness of current regulatory/industry standards applicable to QC operations.

• Ensure timely, effective, and compliant output of laboratories to meet customer and regulatory requirements.
   

Essential Skills/Experience:

• Bachelor’s or advanced Degree in Chemistry, Biological Sciences or related discipline.

• -0+ 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 biopharmaceutical technology industry, with a focus on raw materials.

• In-depth knowledge of analytical method development, validation, and troubleshooting, with a strong understanding of regulatory requirements.

• Ability to work in a matrix environment.

• Excellent communication skills and ability to develop rapport with other functional leaders to influence decision-making.

• Ability to make effective decisions under pressure.
   

Desirable Skills/Experience:

• Prior experience establishing new GMP raw materials testing laboratories.

• Prior experience or familiarity with GMP manufacture of biotechnology products in a clinical environment.
   

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 driven by science and innovation to pioneer new frontiers in oncology research. Our team is dedicated to eliminating cancer as a cause of death through cutting-edge science and technology. With multiple indications and high-quality molecules in our pipeline, we are empowered to make bold decisions that transform patient outcomes. Join us in our collaborative research environment where academia meets industry, creating an unrivaled scientific community committed to improving lives.
 

Ready to make an impact? Apply now and be part of our journey to transform cancer treatment!

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.