Associate Director/Director, Analytical Sciences - Gaithersburg, MD | Biospace
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Associate Director/Director, Analytical Sciences

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
9/25/2017
Position Type:
Full time
Job Code:
R-012287
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-012287
Posted date: Aug. 21, 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/Director, Analytical Sciences 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 analytical development for multiple biopharmaceutical drug candidates from clinical development through registration. Deep understanding of regulatory requirements for development and commercialization of biopharmaceuticals is essential. Major activities include represent Analytical at CMC for late stage biologics. Establish analytical team, development plan and timeline to meet CMC team needs. Lead product characterization, CQA assessment, method development/optimization, setting scientifically justifiable comparability strategies, specification and control strategies. 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. Author, review and/or approve key documents such as: comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.). Lead cross-functional team to develop business processes and guidelines for integrated early and late stage analytical development activities in support of biologics commercialization. Advance MedImmune scientific and regulatory approaches via active participation and leadership across industry trade groups and conferences.  

Requirements

Essential Requirements

A BS, MS or PhD in chemistry, biochemistry or related field with 17+ (BS), 15+ (MS) and 11+ (PhD) years of relevant experience. 

Desirable Requirements

Significant and established experience in the biopharmaceutical industry with relevant experience in late stage product characterization, risk assessment, method development, optimization, validation, regulatory filing, and response to agency questions. Theoretical and hands on knowledge with methods used for biopharmaceutical characterization including peptide mapping, mass spectrometry, electrophoresis and other physicochemical technologies. Experience with regulatory submissions (IND, BLA, MAA, JNDA). Experience leading/developing staff members. Provide technical advice to analytical scientists and associates, where needed, to assure the highest quality of data is developed and presented. Excellent oral and writing skills. Team oriented and able to manage multiple projects cross various development stages. Interact with process, formulation, bioassay and lot release/stability functions to ensure strong cross functional collaborations and integrated process and product development. Experience with product characterization and assay development for novel molecules (antibody drug conjugates, bispecifics, fusion proteins, petides etc) desired.

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