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Gaithersburg, Maryland, United States
Job reference: R-042237
Posted date: Jan. 07, 2019

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.  

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.

Early Stage Formulation Sciences:

This is a leadership role in the Early Stage Formulation Sciences organization reporting to the department Head.  The candidate will be responsible for a variety of tasks including, leading a group of scientists and biochemical engineers focused on formulation and drug product process development, implementing and managing work flow and performance tools, developing processes to improve efficiency, etc. The candidate is expected to demonstrate significant in-depth technical expertise in formulation of biologics, at driving molecule selection for early CMC development, strategies for formulation development for clinical studies, and development of formulations and presentations for mid-late stage development. The candidate is expected to have a strong and well demonstrated experience in development of formulation for novel biologics including fusion proteins, enzymes, antibody drug conjugates (ADC’s), viral vectors, and nucleic acidsDon Texas With 't Employers Lawmakers Undocumented In Of Mess EZx4wqcd. As a group lead, the candidate, will provide strategic direction and technical leadership for design, development and characterization of novel formulations for new products to support their use in preclinical and clinical studies.

Position Requirements:

For all aspects of the role, extensive knowledge of development of monoclonal antibodies, bispecific mAbs, Fc fusion proteins, Antibody drug conjugates, vaccines, nucleotides, and cellular therapies is expected in this role. A strong protein/macromolecule characterization and analytical skills and demonstrated technical and strong leadership experience to develop integrated formulation and drug product process development strategies for preclinical and clinical programs is desired. In addition, extensive understanding of biologic drug structure-function relationship, understanding of degradation pathways and design of formulation and manufacturing controls to develop and manufacture pre-clinical and clinical materials is expected for this role. As the leader in early stage formulation sciences, candidate will be experienced with Regulator Agency interactions in the drug product arena and with composition and review of Regulatory documents for submission. In addition, the candidate is expected to interact effectively with key stake holders in Research, Biopharmaceutical development, Quality, Regulatory CMC, Business Development and Clinical organizations.

Education Requirements:

For this role, you are expected to have degree in Biochemical engineering, Pharmaceutical Sciences, Chemistry, Biochemistry or equivalent field.

PhD and 12 years of relevant industry experience OR Masters degree and 15 years of relevant industry experience OR Bachelors degree and 20 years of relevant industry experience.

MedImmune is a vibrant and strongly scientifically-driven Company and the candidate is expected to apply his/her scientific knowledge to issues and problems arising during product development. In addition, the candidate is expected be active in the external biologics formulation community through, for example, publishing regularly in peer-reviewed journals, presenting at major conferences etc, and to support and maintain a strong scientific culture that exists within the current formulation development organization

The candidate is required to have significant years of experience in leading and managing of people, and demonstrate competency in administrative tasks such as recruitment, assessing work load and resource optimization, and critically assessing work and achievement, developing people, mentoring talent etc. Essential and required is a strong collaborative approach to working with others, and applying this to maintain and develop important relationships with our partners and customers.

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 lawCode To Issues 50 Java Avoid Errors In Software How .

Associate Director, Early Stage Formulation Sciences - BPD

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