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位置: 盖瑟斯堡, 马里兰州, 美国
职位 ID R-063722
发布日期: Nov. 04, 2019

AtAstraZeneca 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 Product Champion, you will serve as the technical lead for the assigned program, working with technical SMEs from AZ and Partner to develop a strategy and drive execution of all technical activities associated with commercial launch readiness and post-launch supply.

The scope of the role will cover biologics programs developed by an AZ partner company (“Partner”) that is being transferred to AZ as license holder prior to commercial launch.

Main Responsibilities:

Major activities in the pre-launch phase includes:

  • Set up and lead a CMC team consisting of SMEs in the various functional areas (DS, DP, Analytical etc.) from AZ and Partner as appropriate.
  • Lead and facilitate technical reviews of regulatory submissions and responses to regulatory authority questions by AZ SMEs to maximize manufacturing flexibility.
  • Develop and execute a CMC transition plan to ensure timely and comprehensive transfer of product technical knowledge from Partner to AZ, including documentation transfer and SME to SME interactions, working closely with relevant technical lead(s) from the Partner.
  • Facilitate Pre-Approval Inspection (PAI) support by AZ technical team.
  • Serve as the technical representative on transition teams as required to provide technical input to the Business Development/Legal teams for developing transition, supply, and quality agreements with the Partner as relevant.
  • Serve as the technical representative on the Global Product Team (GPT) to align product commercialization strategy with technical strategy
  • Serve as the technical representative of the Global Supply Team (GST) and ensure alignment of supply strategy with technical strategy.

Major activities in the post-launch phase includes:

  • Serve as the lead of the CMC team accountable to develop a technical strategy and align execution of technical strategy across relevant manufacturing and testing sites and global functions to ensure uninterrupted product supply.
  • Oversight of process capability (through data trending and statistical analysis) to ensure processes are in a continued state of validation and continuously improving.
  • Facilitate life Cycle Management and Regulatory support of post approval filings.
  • For products manufactured at CMO’s the role also supports site MS&T activities (e.g. change control and deviation support), working with Biologics External Supply (BES) and Global Supplier Quality (GSQ) functions are required.
  • Provide technical oversight of programs to support supply chain expansion (technology transfer, establishment of new manufacturing and/or testing sites) as required.

Essential Job Functions:

  • Establish and lead CMC team meetings to drive end to end technical oversight and develop and execute a product technical strategy.
  • Work with CMC team to maintain the oversight of the process for the product from drug substance raw materials through drug product and 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, Critical Material Attributes,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/technical impact of proposed 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 as appropriate.
  • Ensure product manufacturing remediations and product validations are conducted and executed in line with AZ quality standards. 

Minimum Requirements:

  • 15+ years of experience in a biotech/pharmaceutical company
  • BS Degree in Engineering or life science
  • MS / PhD Degree in Engineering, or life sciences preferred
  • Extensive technical knowledge of commercial biologics manufacturing (greater than 5 years direct experience with biologics manufacturing)
  • Prior experience with authoring and review of CMC sections of regulatory submission, working on partnered programs and /or product launches is a plus
  • 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 communication skills and ability to engage with senior management and SMEs from various functions.

Apply Now!

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.

Associate Director, Biologics Product Champion - Operations
科学管理

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