Director of Microbiology- West Chester, OH

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. As the voice of the patient, every batch we certify is a personal stamp of approval. A place to take Quality seriously - we draw findings from others to develop and understand what it takes to drive our modern approach forward. Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first.

Our West Chester Supply Site (WCH) is a multifaceted and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes and Respiratory.  Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests.

Reporting to the Site Quality Head, the Director of Microbiology is responsible for leading the teams, activities, and systems within the WCH site with regards to microbial control strategies such as the environmental monitoring program, aseptic quality assurance, and aseptic training. This role will also provide technical aseptic assistance to cross functional and cross site teams as needed. The leader in this area is responsible for managing a team in the development, implementation, and maintenance of quality systems in support of aseptic manufacturing. Program/system responsibilities include nonconformance reporting, aseptic related GMP investigations, corrective and preventive actions, GMP document changes, change control and performance metrics.

What you’ll do:

• Manage a team of quality professionals/managers to achieve quality, compliance and business objectives in regards to aseptic quality.
• Analyze, develop and improve quality systems and associated business processes to achieve compliance with global regulatory requirements.
• Develop and maintain policies, standards, procedures and guidelines encompassing all quality systems and facilitate deployment.
• Provide leadership in quality programs and initiatives; make recommendations to continuously improve systems.
• Support investigation activities utilizing root-cause and problem-solving methodologies as well as support CAPA development and implementation.
• Contribute to the design, plan and execution of validation studies as appropriate.
• Develop and maintain department and site metrics for monitoring critical process and Quality attributes.
• Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects.
• Ensure awareness and implementation of Corporate Microbiology policies and standards. Monitor new microbiology requirements/regulations and modify existing policies/standards as necessary to drive leading performance.
• As the Subject Matter Expertise (SME) you will support on all issues related to aseptic microbiology as appropriate. This includes review of trending reports, design of site level programs, responses to audit observations, microbiological contamination events during manufacturing and QC testing, etc., as required.

Essential for the role:

Minimum Requirements:

• Bachelor of Science degree in Microbiology or related field with 7+ years of relevant experience in pharmaceutical/biopharmaceutical quality, manufacturing or regulatory roles.
• Ability to apply knowledge of microbiology theories and principles on a broad base where analysis of situations or data requires an in-depth evaluation of various factors.
• Significant experience with standard microbiology procedures and practices used in the biopharmaceutical industry. This includes familiarity with microbiology, sterility and utility requirements described in major pharmacopoeia (e.g., USP, JP, Ph. Eur.).
• You will have strong knowledge of cGMP practices and a working knowledge of standard manufacturing processes.
• Strong leader able to set direction and instil commitment to a quality culture.
• Excellent people management focused on achieving results through teams and developing people.
• Ability to successfully work and lead cross functional and cross site teams.

Preferred Background:

• Master’s or PhD degree in Microbiology or related field.
• 2+ years of aseptic environment and related investigation experience with demonstrated strong root cause analysis proficiency and effective CAPA implementation

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 recognizing their potential. Interested? Come and join our journey!

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

Find out more on Social Media:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca/?hl=en

About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

Closing Date

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.