The Sr Manager / Associate Director, Biosafety Testing will provide support to enterprise wide biosafety activities within the Biopharmaceutical Development (BPD) group.
This position will provide overall scientific and strategic leadership in the areas of viral and biosafety testing for Biopharmaceutical Development at AstraZeneca.
Essential Job Functions:
Possess in depth knowledge of biological safety testing requirements for biologics manufacture (including cell banks and drug substance) as mandated by compendial methods and various health authority regulations/requirements for adventitious agent detection.
Monitoring new biosafety requirements/regulations and modifying existing policies/standards as necessary
Owner of all biosafety testing related documents including Standard Operating Procedures (SOP’s) within the BPD group. Accountable for coordinating the biennial/triennial review of these procedures and for updating them when required.
Performing the technical review and approval as a subject matter expert (SME) of all biosafety related protocols and SOP’s used at contract testing laboratories to test samples for AstraZeneca and ensure that they are in compliance with current regulatory requirements and/or AstraZeneca’s requirements
Performing the comprehensive technical/SME review of all biosafety test reports from contract testing laboratories and working with them to correct/revise any errors in the reports.
Provide technical leadership to timely resolve any non-conformances, deviations or out-of-specification results obtained at contract laboratories when testing biosafety samples submitted by AstraZeneca or partners.
Interact closely with the Development Quality department at AstraZeneca to ensure that Certificates of Analyses and other documents in Quality systems are approved in a timely manner and enable a rapid and dynamic pipeline.
Provide technical input in responding to questions on biosafety related issues from regulatory agencies on IND’s, IMPD’s, BLA’s, MAA’s and other similar regulatory submissions.
Provide technical leadership in designing the biosafety testing strategy for new modalities and evaluating the strategy for existing modalities to ensure compliance with regulatory and AstraZeneca’s requirements
Evaluate reports from third parties, as required, for due diligence or partnership activities. This evaluation should consider compliance to both compendial requirements as well as AstraZeneca’s internal requirements
Participate in audits (both routine and for-cause) of contract testing laboratories as the SME in biosafety testing.
Provide training and mentoring for staff in Biopharmaceutical Development to build bench strength and ensure that multiple employees have the necessary skills to be back-up technical experts in biosafety testing
Attend project-related meetings on an as-needed basis and provide the teams with technical expertise on matters relating to biosafety testing
Attend and present at relevant conferences (e.g., BPOG, CAACB, PDA, NIIMBL, etc.) and bring learnings back to AstraZeneca
Provide input and review for regulatory filings as required in order to ensure consistency in depth of content and strategic approach
Provide forward thinking for biosafety testing strategy in anticipation of future needs
Strong Project Management, interpersonal and organizational skills
Must have demonstrated knowledge in both virology and microbiology
Has a thorough understanding of all aspects of biosafety testing, including compendial, Code of Federal Regulations (CFR) and ICH requirements, WHO/EMA/FDA regulations, guidance’s for industry documents, etc.
Has experience conducting/reviewing biosafety tests either in an industry or contract testing laboratory setting.
Must also have technical expertise in microbiology methods such as sterility, bioburden and endotoxin testing
Has a working knowledge of IT Quality Systems such as TrackWise.
Decisions or recommendations consistently result in achieving one or more key project objectives.
Internal recognition as biosafety testing expert by the AstraZeneca communities.
Has demonstrated leadership through project team participation, internal consulting and ability to achieve consensus amongst groups with diverse needs
Has a clear understanding of departmental direction and is expected to voice opinions and ideas.
Frequent inter and interdepartmental collaborations.
Establishes contacts with groups at all AstraZeneca groups and has contacts with customers and suppliers.
Demonstrates ability to resolve conflicts between team members.
Demonstrates the ability to effectively explain complex scientific concepts to a broader, diverse audience.
Education and Experience:
Senior Manager: BS in biology with a minimum of 9 years of experience in virology and microbiology methods in a GMP environment, or MS with at least 7 years of experience, or PhD with a minimum of 4 years of experience in a biotech/pharmaceutical environment.
Associate Director: BS in biology with at least 14 years of experience in virology and microbiology methods in a GMP environment, or MS with a minimum of 12 years of experience, or PhD with at least 9 years of experience in a biotech/pharmaceutical environment.
Success in these areas will require strong technical/scientific and leadership skills, experience with all areas related to virology and the ability to project cross-functional influence.
Must have significant experience with standard virology and microbiology procedures and practices used in biosafety testing in the biopharmaceutical industry. This includes familiarity with virology and microbiology regulations and requirements described in major pharmacopoeia (e.g., USP, JP, Ph. Eur.), ICH, CFR, and other guidance’s/regulations issues by the WHO/EMA/FDA
Must have strong knowledge of cGMP practices and a working knowledge of standard manufacturing processes
Experience in investigating and troubleshooting failures in biosafety tests including sterility, bioburden and virology-based methods
Must have the ability to author complex technical documents clearly and efficiently.
Proven ability to influence across functions and organizations
Must have strong project management skills in a matrix environment.