Senior Director/Director, Bioassay Development - Gaithersburg, MD | Biospace
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Senior Director/Director, Bioassay Development

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
9/26/2017
Position Type:
Full time
Job Code:
R-012380
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-012380
Posted date: Aug. 30, 2017

Senior Director/Director - Bioassay Development - Gaithersburg, Maryland

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 Director or Senior Director, Bioassay Development 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.

This position will provide scientific, operational, and strategic leadership for the Bioassay Development group within the Analytical Sciences function of Biopharmaceutical Development (BPD) organization at MedImmune.  This group is responsible for design, development, qualification and transfer of characterization and release/stability immunological and biological test methods for MedImmune’s biologics portfolio.  The group is also responsible for in-process characterization and test support for process, formulation, and device development groups, as it relates to these methods. 

Major Duties and Responsibilities (including supervising others):

Strategic

  • Establish strategy, direction and objectives for bioassay functional area that are consistent with current BPD and MedImmune strategy and goals.
  • As a member of the Analytical Sciences Leadership team, help develop and sustain the strategy and goals for Analytical Sciences.
  • Actively participate in other leadership teams (eg. Development Leadership Team) to ensure progress of portfolio and Science.

Portfolio

  • Engage with Research project teams to fully understand the mechanism of action of the candidate drugs that would be the basis for bioassays.
  • Develop plans for clinical and commercial products to support clinical product development, product life-cycle management and associated regulatory submissions.  This includes developing and implementing scientifically justifiable comparability strategies and release/stability criteria for various scenarios including accelerated product development. 
  • Proactively, participate in diligence activities with Business Development and author summary of findings.
  • Oversee the creation and review of documents such as: method development reports, SOPs, validation protocols/reports, CMC regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications.
  • As needed, lead CMC team(s) across Biopharmaceutical Development

Innovation

  • Develop cutting-edge technologies for studying candidate molecules, new product modalities as well as to better understand structure – activity relationship of molecules
  • Drive continuous improvement of platform methods to enhance performance and efficiency.
  • Develop and advance innovative strategies that change the regulatory paradigm by engaging regulators.
  • Influence internally and externally to gain agreement on innovative approaches
  • Provide technical advice, where needed, to assure the highest quality of data is developed and presented.  
  • Encourage external publications/presentations, and provide critical review.

Communication

  • Serve as spokesperson for BPD in communications with regulatory agencies, MedImmune/AZ senior leadership meetings, R&D product development teams for all therapeutic areas, and other internal and external groups of interest.
  • Maintain effective communications with other functional areas within BPD as well as Research, Regulatory Affairs, Clinical Development, Quality Control, Quality Assurance, and Biologics Operations.

Functional

  • Facilitate tech transfer of methods to the Gaithersburg cGMP testing group, commercial QC groups and to CMO’s
  • Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards.
  • Ensure effective day to day operations of the organization including talent development, performance management, budgeting, etc. 
  • Catalyze a culture of continuous improvement within the organization.
  • Manage the functional spend within allotted budget

People management

  • Develop leaders at all levels within the organization to become effective functional, scientific and matrix leaders.
  • Carry out performance management and manage people development activities for bioassay staff

Requirements/Qualifications:

Education:  Ph.D. in Biology/Microbiology, Biochemistry, or equivalent required.

Experience:  Significant and established experience in a biopharmaceutical company with relevant experience in bioassay/immunoassay method development, optimization, validation, cGMP testing, and tech transfer.  Demonstrated experience progressing therapeutic proteins to licensure is a plus.  The successful candidate must also have significant experience with methods used for biopharmaceutical characterization as well as a thorough knowledge of structure-function relationship of therapeutic proteins.  Understanding of how development teams support multiple therapeutic areas including infectious diseases, inflammation, and oncology is essential.  Experience effectively leading/developing a diverse team of 20-plus staff members is highly desirable. 

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.

Requirements

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