Associate Director – Raw Materials Testing

Do you have a passion for Science Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines Then AstraZeneca might be the one for you!

At AstraZeneca we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial thinking big and working together to make the impossible a reality. If you are swift to action confident to lead willing to collaborate and curious about what science can do then youre our kind of person.

About AstraZeneca in Gaithersburg MD:

Our Gaithersburg Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3500 experts in our field and is only a short drive from Washington DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here we play host to some of the most cutting-edge technology and lab spaces all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center employee healthcare clinic electric vehicle charging stations dry cleaning full-service cafeteria and copy center. This is where youll find newly-designed activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.

Summary of the group

The Associate Director of Raw Materials Testing will be responsible for establishing and overseeing raw materials testing and associated control processes within the organization. This will include establishment of the raw materials laboratory oversight of raw materials testing processes including method development validation; and development and implementation of strategies for testing raw materials including the use of appropriate analytical techniques and instrumentation; collaboration with cross-functional teams to establish testing specifications and requirements for raw materials; management of the testing laboratory and ensuring adherence to GMP pharmacopeial standards and other regulatory guidelines; and leading investigations into raw material quality issues implementing corrective and preventive action to mitigate risks. This role will additionally lead and develop a team of raw material professionals providing mentorship and guidance.

Main Duties & Responsibilities

Role Requirements

• 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 creation of specifications testing parameters and relevant governing documents.
• Provide an interface /communication between manufacturing quality and relevant functions for timely testing and release of materials.
• 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.
• Maintain awareness of current regulatory/industry standards and regulations applicable to QC operations e.g. relevant pharmacopeia FDA and EU guidelines and updates PDA technical reports etc.
• To 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).

Education & Experience Requirements:

Degree and number of years experience

• Bachelors or advanced Degree in Chemistry Biological Sciences or related discipline.
• BS and10 years of experience in biopharma medical device or pharmaceutical manufacturing.
• MS and 6 years of experience.
• 2 years of managerial/supervisory experience.

Required Skills

• 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 (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.

Desired Skills

• Prior experience establishing new GMP raw materials testing laboratories
• Prior experience or familiarity with GMP manufacture of biotechnology products in a clinical environment.

Why AstraZeneca

At AstraZeneca when we see an opportunity for change we seize it and make it happen because any opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means were opening new ways to work pioneering cutting edge methods and bringing unexpected teams together. Interested Come and join our journey.

The annual base salary for this position ranges from $ 127963.20 - 191944.80 USD Annual

However base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly 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 salary (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.

So whats next!

Are you ready to bring new ideas and fresh thinking to the table Brilliant! We have one seat available and we hope its yours.

Where can I find out more

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