Associate Director, Product Champion
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 an Associate Director, Product Champion
in Gaithersburg, MD,
you'll play a pivotal role in channeling 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.Main Duties and Responsibilities
The Product Champion has a product focus and serves as the technical lead within operations for the assigned product(s) throughout the commercial lifecycle. Major activities include
For Commercial Products
- Serve as CMC Team Lead for Commercial Products
- Life Cycle Management and Regulatory support of post approval filings.
- Serve as Operations Technical Lead for Initial File and Response 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
Maintain the oversight of the process for the product(s) assigned from drug substance raw materials through drug product primary packaging by:
For Pipeline Products
- 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) knowhow to 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
- 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.
- BS Degree in Engineering or life science
- Greater than 10 years experience in a biotech/pharmaceutical company
- Extensive technical knowledge of commercial biologics manufacturing and/or development (greater than 5 years direct experience with biologics manufacturing and/or development )
- 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
Next Steps - Apply today!
- MS / PhD Degree in Engineering, or life sciences preferred
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.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.