Manager, Investigations/Tech Transfer - Gaithersburg, MD | Biospace
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Manager, Investigations/Tech Transfer

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
8/16/2017
Position Type:
Full time
Job Code:
R-011426
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-011426
Posted date: Jul. 27, 2017

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.  As a Manager, R&D in Gaithersburg, MD, 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.

Position Summary

The Manager, R&D will lead and drive manufacturing deviations/investigations providing direction, follow up and resolution/closure to complex issues stemming from the non-conformance process. The individual will independently analyze complex issues using risk appropriate decision making and engage additional technical resources from across the organization as appropriate.  The individual will be responsible for leading, expediting, summarizing, and closing manufacturing investigations and must have demonstrated technical writing skills. This role is a manager of process and does not have direct reports but may have matrixed staff for specific responsibilities. 

Requirements

Position Requirements:

Solid technical understanding of biologics process.

Lead complex manufacturing investigations with demonstrated technical writing ability; expedite, summarize and close manufacturing investigations.

Provide direction and follow up to more complex issues stemming from the non-conformance process.

Work cross functionally with the all aspects of organization to remediate events/issues and identify GMP phase appropriate CAPAs necessary to close out the investigation.

Coordinate involvement of cross functional teams with appropriate expertise as required to resolve issues.

Independently analyze complex issues using risk appropriate decision making.

Demonstrated ability to interpret and negotiate regulatory guidance as it applies to phase appropriate decision making

Support an environment of teamwork and collaboration.

CMC Team representative for Manufacturing Sciences as required.

Create, Review and approve manufacturing batch documentation as requested.

Lead continuous improvement, process improvement initiatives within Manufacturing Sciences department as requested.

Work in consultation with the MS Training Function to ensure learnings from non-conformance process are integrated into future training opportunities.

Support internal and external inspections/audits.

Utilize OE principles and quality risk management.

Work independently without appreciable direction.

Education Requirements & Experience:

  • 10+ years’ experience in biotech/pharmaceutical industry with Bachelor’s or Master’s (8+ years’ experience) preferably in Engineering or Science.
  •  Experience in multiple areas which may include but not limited to Process Development, cGMP Manufacturing, or Quality Assurance backgrounds.
  • Knowledge of the processes and equipment involved in biologics manufacturing.
  • Experience in validation activities associated with biologics processes, technology transfer and equipment and/or process validation.
  • Experience in FMEA, QRM and Six Sigma preferred.
  • Demonstrated technical writing skills.
  • Possesses excellent organization and interpersonal skills.
  • Ability to build effective teams and foster collaborative relationships.
  • Demonstrates strong presentation and facilitation skills.
  • Highly motivated self-starter with commitment to meeting established timelines.
  • Demonstrates creative thinking and a willingness to implement new approaches.
  • Requires computer expertise in MS Office Suite.

*LI-MEDI

~BSP

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.