Associate Director, Analytical Sciences - Biologics Characterization and Method Development - Gaithersburg, MD | Biospace
Get Our FREE Industry eNewsletter

Associate Director, Analytical Sciences - Biologics Characterization and Method Development

MedImmune, LLC

Apply
Location:
Gaithersburg, MD
Posted Date:
9/25/2017
Position Type:
Full time
Job Code:
R-008837
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-008837
Posted date: Aug. 22, 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, Analytical Sciences - Biologics Characterization and Method 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.

Main Duties and Responsibilities:

This position will lead phase-appropriate analytical development strategy for multiple biopharmaceutical drug candidates from research through registration. Major activities include product characterization, physicochemical method development/optimization, setting scientifically justifiable comparability strategies, specification and control strategies. Serve as a subject matter expert in biophysical and/or other physicochemical areas to lead new technology development. Provide technical advice to analytical scientists and associates, where needed, to assure the highest quality of data is developed and presented.  Author, review and/or approve key documents such as: method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.). Represent analytical sciences in verbal and written communications with regulatory agencies, MedImmune/AZ senior leadership meetings, R&D product development teams for all therapeutic areas. Initiate and lead cross-functional team to develop business processes and guidelines for integrated early and late stage analytical development activities in support of biologics commercialization. Publish/present in high quality journals/conferences. Advance MedImmune scientific and regulatory approaches via active participation and leadership across industry trade groups and conferences.

Requirements

Essential Requirements:

•             A PhD in chemistry, biochemistry or related field with 11-13 years of relevant experience. 

Desired Requirements:

•             Significant and established experience in the biopharmaceutical industry with relevant experience in product characterization and analytical method development of mAbs and novel formats, such as antibody-drug conjugates, bispecifics, recombinant proteins and peptides. 

•             Knowledge and experience with dendrimers, nanoparticles, nucleic acid/lipid nanoparticles highly desired.

•             Knowledge with methods used for biopharmaceutical characterization including peptide mapping, mass spectrometry, electrophoresis and other physicochemical technologies.

•             Theoretical and hands-on competency in several of the biophysical technique categories: spectroscopy (circular dichroism, fluorescence, infrared spectroscopy, RAMAN, NMR); calorimetry (differential scanning calorimetry, isothermal titration calorimetry); protein association analysis (analytical ultracentrifugation, light scattering, chromatography); particle analysis (light obscuration, flow microscopy, FTIR microscopy).

•             Leader in particle, higher order structure (HOS), and biophysical characterization.

•             Team oriented and able to manage multiple projects cross various development stages.

•             Excellent oral and writing skills.

•             Experience leading/developing staff members.

*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.