QC Senior Microbiologist, Biosafety Testing
AstraZeneca

Job Info

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

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the global leading pharmaceutical companies.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 experts in our field, and it is only a short drive from Washington, DC. It is filled with cutting edge technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and inspired at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency 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.

What you will do:

• To provide expert technical and analytical support to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology. The individual should be qualified to graduate level/or equivalent in a scientific discipline, with experience of working in a Good Manufacturing Practice laboratory environment. Will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Global Laboratory Practice. Must have An understanding of the Quality Control function, and it's role and importance to the business.

Main Responsibilities:

• This position will provide scientific and compliance-minded expertise in the areas of viral and biosafety testing for QC, with support focus to include emerging technologies and technology development
• Acts as a liasion between Biopharmaceutical Development (BPD), Quality Assurance (QA), and Outside Testing Laboratories (OTL)
• Performs technical review and approval for all biosafety-related SOPs, testing protocols, and reports
• Participates in shaping the strategy for biosafety testing for AZ products
• Represents the team as Subject Matter Expert (SME) in viral and biosafety testing, mycoplasma and sterility testing, as well as routine microbial testing such as endotoxin, sterility, and bioburden
• Ensures that systems and processes owned by the team are in a state of control and are effectively managed and maintained
• Prioritizes own workload effectively and efficiently, keeping in mind the needs of the stakeholders and commitments of the team
• Train others on tasks, processes, and equipment in the labs
• Participate in and approve laboratory or process deviations, including laboratory investigations
• Ensure regulatory compliance of and appropriate availability of laboratory equipment to meet customer needs
• Serves as SME and Data Integrity champion for laboratory activities as appropriate.
• Serve on global teams/forums as appropriate
• Act as a Lean champion, embracing Lean tools and principles and implementing continuous improvement initiatives.
• Author and approve of quality systems records (eg investigations, CAPAs, SOPs) and technical documents (eg trend reports, qualification and validation documents)

Minimum Requirements:

• Bachelor's degree in a related subject (eg... Biology)
• High level of knowledge and competence with standard virology and microbiology procedures and practices used in biosafety testing in the biopharmaceutical industry
• Experience conducting biosafety tests in a regulated lab environment
• Demonstrated knowledge of cGMP practices
• 2+ years' experience in a GMP QC Micro lab

Desirable:

• Post-graduate degree such as Masters or PhD in Biology, Virology, or related subject
• 4+ years QC microbiology experience
• Experience in aseptic manufacturing and biologics
• Demonstrated project leadership capabilities

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

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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