At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Principal Scientist in Gaithersburg, MD, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
This position will provide overall scientific and strategic leadership for Medimmune’s analytical operations.
Key area of responsibility will be enterprise wide analytical activities in Operations, which include the following functions
Accountable for analytical method transfer from Medimmune’s Biopharmaceutical Development to commercial manufacturing sites within AZ Biologics operations as well as outside testing laboratories.
Establish harmonized processes and best practice on various global analytical activities within Biologics and broader AZ operations network.
Technical support for new business opportunity, due diligence and direct technical support as needed at the site level in a consulting or SME role.
Responsible for ensuring harmonized compliance to internal standards and policies related to analytical operations across all biologics manufacturing sites
Bridging between R&D & Operations to progress the pipeline
Coordinating collaboration among AZ operations/Quality network via a cross site analytical forum and/or QC Forum
Author technical documents in the subject matter for regulatory submissions
Provide input and review for regulatory filings in order to ensure consistency in depth of content and strategic approach
Bringing the external environment into Medi, e.g. benchmarking
Provide forward thinking in anticipation of future needs
Strong Project Management and interpersonal skills
Applies extensive expertise as a generalist, or specialist.
Has a working knowledge of related disciplines.
Maintains high level of expertise through review of current scientific literature, submissions to scientific journals, and attendance and participation at conferences focused on the research and development efforts of the company.
Displays a general knowledge Manufacturing process and working knowledge of drug development
Has a working knowledge of analytical testing and methods in a manufacturing environment
Develops solutions to complex problems requiring ingenuity and creativity.
Applies knowledge of scientific theories and principles on a broad base where analysis of situations or data requires an in-depth evaluation of various factors.
Displays knowledge about how the organization works. Can solve problems through formal channels and informal networks.
Work is performed with limited direction.
Has latitude in determining scientific objectives of assignment.
Work is monitored for scientific judgment and achievement
Decisions or recommendations consistently result in achieving one or more key project objectives.
Internal recognition as an emerging expert by the AstraZeneca scientific community through objective criteria such as publications, patents, internal presentations, and critical contributions to technology development.
Has demonstrated leadership through project team participation, internal consulting and mentoring
Has a clear understanding of departmental direction and is expected to voice opinions and ideas
Education and Experience Guidelines:
BS with 20 years of experience in an analytical development or QC role in an industrial setting, or MS with 17years of experience, or PhD with 10 years of experience
Success in these areas will require strong technical/scientific and leadership skills, experience with commercialization of biologics, process technology transfer, project management and the ability to project cross-functional influence.
Competencies Related Performance:
Ability to Deal with Ambiguity
• Must have significant experience with most of the following standard analytical techniques used in the biopharmaceutical industry: e.g., UV-Vis, HPLC, LC-MS, GC, FT-IR, SDS-PAGE, IEF, CE, ELISA, mass spectrometry, bioassay.
• Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements
• Good understanding of biosafety assays, cell bank testing, and microbiological requirements in a manufacturing environment
• Experience in process and analytical technology transfer within and between organizations, manufacturing support and troubleshooting
• Demonstrated teamwork, organizational, and leadership skills
• Proven ability to influence across functions and organizations
• Project management skills and strong technical writing skills
Nice to have” skill set
• Use of LIMS
• Statistical analysis software (e.g. JMP), multivariate data analysis software
• Data historian software (e.g. OSI /PI) and process data management (e.g. Discoverant)
• Familiar with Microsoft Project or other scheduling software
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.