Associate Director, QC - (Frederick, MD) - Frederick, MD | Biospace
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Associate Director, QC - (Frederick, MD)

MedImmune, LLC

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Location:
Frederick, MD
Posted Date:
8/24/2017
Position Type:
Full time
Job Code:
R-012025
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location:
Frederick, Maryland, United States
Job reference: R-012025
Posted date: Aug. 04, 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 an Associate Director, QC in Frederick, 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.

As an Associate Director, QC you will be responsible for all assigned aspects of QC at the Frederick Manufacturing Center, potentially including the testing of raw materials, in-process, drug substance, drug product, stability and microbiology samples in support of late stage clinical and commercial programs.  Responsibilities may also include oversight of some or all aspects of the late stage clinical or commercial drug product stability program, QC Analytical, QC Technical Services, QC Information Systems, QC Compliance Management, QC Planning, Environmental Monitoring or QC Sample Management.  You will provide leadership, direction and mentoring to ensure that the QC organization is successful in meeting the quality and manufacturing objectives in support of site goals.  You will implement and maintain, as required, QC computerized systems (e.g., LIMS, lab instruments) and equipment, as well as, ensure robust QC planning, metrics and analytical tech transfer project management occur in support of department, site and company goals.  You will direct efforts to maximize operational effectiveness to ensure high-level testing, planning and computerized system support.  You will represent QC department on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure deliverables are aligned with site business objectives.  You will oversee resource, equipment and capital requirements of the function area.  You will also facilitate the growth and development of QC staff, provide strategic support to the QC Director for QC operations and long-term growth, and demonstrate excellent communication skills through internal and external channels.

Knowledge

  • Responsible for the successful operation of activities of major significance to the organization.  Oversees daily operational activities while working with Director to establish mid and long term priorities and goals.
  • Apply extensive expertise as a generalist or specialist.
  • Possess working knowledge of related disciplines, including: analytical testing, Operational Excellence / Lean Sigma, IT/IS, and budget management.

Problem Solving:

  • Develop creative solutions to complex problems using available theories and knowledge.

Freedom to Act:

  • Work is performed without appreciable direction. 
  • Support organizational objectives, and interprets company policies. 
  • Complete work is reviewed, from a mid-term perspective, for desired results. 
  • Interpret and executes policies and procedures that typically affect subordinate organizational units. 
  • Recommend modifications to operating policies.

Impact

  • Decisions affect the success of the group.  Erroneous decisions or recommendations would result in failure to achieve major goals and objectives of the site and organization.

Interpersonal Communication

  • Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling or specific phases of projects or contracts.  Conducts briefings and participates in technical meetings for internal representatives concerning specific operations.
  • Frequent inter and intradepartmental collaborations.

Supervisory/Management Skills

  • Generally accomplishes results through lower management levels. 
  • Determine and establish organizational structures and supervisory relationships, subject to top management approval.  Often responsible for managing a major segment of the company.

Requirements

Preferred Education/Experience

  • Masters accepted but PhD preferred, preferred comprehensive background in Analytical Chemistry.
  • Preferred 10+ years’ experience in Commercial Quality Organizations, including 3+ years managing individual contributors and other people managers.

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.

~BSP

*LI-MEDI