Manager Analytical Sciences, GMP

Astrazeneca Gaithersburg , MD 20877

Posted 4 months ago

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. Here at MedImmune, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.

We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Location: Gaithersburg, MD

Key Responsibilities:

The incumbent will be responsible for management of the Analytical Sciences GMP testing group, to ensure that release and stability testing of clinical trial material is performed according to FDA, global Ministry of Health (MOH), and MedImmune/AstraZeneca requirements.

Major activities include:

  • Coordination of GMP testing and method transfer activities

  • Ensuring the accuracy and integrity of GMP data

  • Development and management of personnel

  • Providing technical advice to team members

  • Representing Analytical Sciences during audits and meetings with external partners

  • Monitoring and presenting group metrics

  • Leading/participating in process improvement activities.

Education Requirements:

Educational requirements include a degree in chemistry, biochemistry or related field

BS with 10+ years of relevant industry experience; MS with 8+ years of industry experience or PhD with some relevant industry experience preferred

Job Requirements:

  • Prior experience in a Quality Control or GMP testing laboratory supporting clinical development of biologics

  • Knowledge of cGMP and regulatory requirements for biologic products (FDA, EU, other global MOH)

  • Expertise with analytical methods for analysis of well-characterized biologics such as: chromatography (SEC, IEC, HIC), immunoassay (ELISA, SPR) and compendial methods (appearance, KF, CCI, pH).

  • Prior experience with method transfer, qualification/validation in a GMP environment

  • Demonstrated ability to lead and develop staff members.

  • Prior experience implementing operational excellence or continuous improvement methodology in a laboratory testing environment

  • Excellent oral and writing skills. Ability to work in a team environment.

Preferred Qualifications:

  • Prior experience with analytical testing of combination products and associated device functionality methods (BL/GF, DAF) desired

  • Prior experience with CMC development for clinical stage biologics and authoring of regulatory submissions.

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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.


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