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Associate Director, Product Champion (Pharma) - Operations

Plats Gaithersburg, Maryland, USA Jobb-id R-062680 Datum inlagd 10/03/2019

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 the Associate Director, Product Champion you will have a commercial biologics product focus and serves as the technical lead within operations for the assigned commercial product(s) throughout the commercial lifecycle. Major activities include oversight of process capability (through data trending and statistical analysis) to ensure processes are in a continued state of validation and continuously improving, Life Cycle Management and Regulatory support of post approval filings. In addition, for products manufactured at CMO’s, the role also supports site MS&T activities (e.g. change control and deviation support).

For the support of commercial projects, you may also serve as the operations representative on assigned pipeline product(s) on the Product Development Team (PDT) and 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

Main Responsibilities:

  • 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:
    • 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
  • 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.

Minimum Requirements:

  • BS Degree in Engineering or life sciences
  • 10+ years of experience in a biotech/pharmaceutical company
  • Extensive technical knowledge of commercial biologics manufacturing  (greater than 5 years direct experience with biologics manufacturing)
  • 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

Preferred:

  • MS / PhD Degree in Engineering or life sciences preferred

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 embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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