Associate Director, Product Champion - Operations job in Gaithersburg
|Employer:|| AstraZeneca Pharmaceuticals|
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.|
•The Product Champion has a product focus and serves as the technical lead within operations for assigned products throughout the commercial lifecycle. Major activities include
•Serve as CMC Team Lead for Virology, Nucleic Acid, and Gene Therapy based Commercial Products
•Life Cycle Management and Regulatory support of post approval filings.
•Serve as Operations Technical Lead for Initial Filing and Responses to Questions
•Oversight of process capability (through data trending and statistical analysis) to ensure processes are in a continued state of validation and continuously improving
•For products manufactured at CMO's the role also supports site MS&T activities (e.g. change control and deviation support).
•Serve as Operations representative on assigned pipeline product(s) on the Product Development Team (PDT) and Pipeline CMC Team: serving as the champion of the product within operations to ensure alignment and drive pipeline progression as well as provide strategic and technical guidance and input to development to enable successful future commercial manufacture.
•Serves as Corporate SME in biosafety testing methods. Provides technical support for any challenges/issues involving adventitious agents during the generation and testing of raw materials (including Specific Pathogen Free-[SPF] eggs), cell banks, drug substance and drug product. Provides leadership to proactively develop and maintain procedures to investigate and remediate contamination events involving adventitious agents during manufacturing. Keeps abreast of science and technology advancements and leads efforts to identify, evaluate, qualify/validate and implement rapid methods to test for adventitious agents. Should have ability to author sections of license applications related to adventitious agents testing. Be available to be on call for help during regulatory inspections at AZ-Bio sites.
Essential Job Functions:
•For Commercial Products
• Maintain the oversight of the process for the product(s) assigned from drug substance raw materials through drug product primary packaging by:
• Lead the CMC Team Post Approval
• Ensuring that CPV parameters from production, QC, control systems, etc. are prospectively tracked
• Ensuring that all critical variables are tracked as appropriate for the assigned product(s) (Critical Process Parameters CPP, Critical Quality Attributes CQA, Critical In Process Control parameters CIPC, Critical Material Attributes CMA, etc) using statistical analysis and conducting regular product specific data trending
• Performing Continued Process Verification (CPV), data trending and statistical analysis (where applicable)
• Issuing quarterly/annual data trending report and support APQRs
• Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle
• Assess the product impact of manufacturing changes
• Provide MS&T (Manufacturing, Science & Technology) input into deviations, investigations, OOE's and OOS's, technical complaints
• Identify process optimization opportunities and ensure execution at 3rd party manufacturer
• Ensure product manufacturing remediations and product validations are conducted and executed in line with Medi/AZ quality standards
• For Pipeline Products
•Serve as an empowered Operations representative on the PDT, working collaboratively and cross-functionally with other PDT members contributing to product vision, strategy, plans & delivery -- must consult with functional leaders and bring Operations view to the table to support PDT decision-making and planning
•Develops long term commercial manufacturing strategies in conjunction with Operations representatives and Development CMC teams to ensure delivery of clinical and commercial product that is consistent with Operations long range strategy and PDT product commercialization strategies.
•Responsible to align Development and Operations technical decisions necessary through completion of Process Validation to ensure the commercial viability of the manufacturing process.
•Partner with Regulatory and CMC teams to support the technical content of filings and ensure flexibilities are built in to minimize impact of future process changes.
•Ph. D with 9 years' of relevant experience including a minimum of 3 years in a biotech/pharmaceutical company
•Extensive experience in virology and molecular biology required. Must have broad technical experience working with RNA/DNA viruses and manipulating viral systems
• St rong knowledge of cell biology and molecular biology techniques .
•Must have demonstrated expertise in recombinant DNA and molecular cloning techniques, cell-based viral assay development and screening, reverse genetics systems, and immunology.
•Previous experience in the use of viruses as vectors, immunotherapy, or oncolytic virus-therapy is highly desirable
•Experience with commercial viral vaccines is preferred.
•Extensive technical knowledge of commercial biologics manufacturing (minimum of 3 years direct experience with biologics manufacturing). Knowledge of SPF egg based production systems will be an advantage
•Must have a deep understanding of all regulatory requirements and guidance's pertaining to the testing of biologics for adventitious agents.
•Broad based understanding of Operations including Manufacturing Operations, Supply Chain, Quality Assurance, and Quality Control.
•Excellent communication skills with the ability to work effectively in cross functional teams and effectively influence team members. Establish effective relationships with stakeholders.
•Ability to work in a complex, dynamic, global environment and willingness to travel when necessary.
•Innovative problem-solving skills
•Strong technical writer
•Statistical analysis experience
•PhD Degree in Virology, Molecular Biology, or related disciplines with at least 9 years' relevant experience is required, or MS with at least 10 years
Next Steps - Apply today!
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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.