Head of Analytical Sciences job in Gaithersburg
|Employer:|| AstraZeneca Pharmaceuticals|
|Category:||Research and Development|
With one of the largest, most robust pipelines in the industry - including more than 120 research projects and product candidates - MedImmune comprises nearly half of AstraZeneca's overall R&D portfolio. We are focused on three core therapeutic areas: Oncology; Respiratory, Inflammation and Autoimmune; and Cardiovascular and Metabolic Disease. |
Given Oncology is one of the 5 key growth platforms for the company's future success, we have an ambitious vision of delivering 6 new medicines to patients by 2020. Our strategy underpinning this vision is to target areas of unmet need, incorporate biomarker-driven patient selection, maximize value across tumor types and stages of disease, and focus on development of novel combinations. At MedImmune, our emphasis is on immuno-oncology and antibody drug conjugates (ADCs).
This position will provide scientific, operational, and strategic leadership for the Physicochemical and Biophysical Analytical Sciences group within the Biopharmaceutical Development organization at MedImmune. This group is responsible for structural characterization of a broad range of biologic molecules; and development, qualification and transfer of in-process, characterization and release test methods, including chromatography, electrophoresis, mass spectrometry and other physicochemical and biophysical methods for MedImmune's biologics portfolio. The group is also responsible for in-process characterization and test support for process, formulation, and drug delivery/device development groups.
Major Duties and Responsibilities (including supervising others):
• Establish strategy, direction and objectives for diverse group of analytical functions that are consistent with overall function, R&D, and MedImmune goals and objectives.
• Develop strategic 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.
• Serve as a member of the Biopharmaceutical Development (BPD) Leadership team and represent BPD on MedImmune and AstraZeneca governance committees.
• Provide technical advice, where needed, to assure the highest quality of data is developed and presented. Oversee the creation and review of presentations for outside scientific meetings and conferences to assure they meet corporate standards.
• Serve as spokesperson for Development in verbal and written communications with regulatory agencies, R&D product development teams for all therapeutic areas, and other internal and external groups of interest.
• 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.
• Develop new cutting-edge technologies for improving efficiency of in-process testing and product characterization.
• Actively maintain and evolve the department's strategic direction to meet organizational needs.
• Maintain effective communications with other functional areas within BPD as well as Regulatory Affairs, Clinical Development, Quality Control, Quality Assurance, Commercial Operations and Research.
• 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.
• Inspire and support a can-do, solutions focused, science led culture within the organization.
• Develop leaders at all levels within the organization to become effective functional, scientific and matrix leaders.
• As needed, lead CMC team(s) across Biopharmaceutical Development
Education: Ph.D. in Biochemistry, Chemistry, or equivalent required
• Significant and established experience in a biopharmaceutical company with relevant experience in analytical method development, optimization, validation, cGMP testing, and tech transfer for a portfolio of diverse molecular formats.
• Experience working across all phases of R&D including discovery, pre-clinical, clinical development and post-marketing life cycle management.
• Demonstrated experience progressing biologics to licensure including identification of critical quality attributes, development of control strategies, engaging regulators with innovative approaches to change the regulatory paradigm; and influencing internally and externally.
• The successful candidate must also have significant experience with methods used for structural characterization including peptide mapping, mass spectrometry, electrophoresis and other physicochemical and/or biophysical technologies.
• Understanding of how development teams support multiple therapeutic areas including infectious diseases, inflammation, and oncology is essential.
• Experience leading and developing a diverse team of 50 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.