Sr Technical Project Manager
Sr Technical Project Manager
苏州新区 | 10年以上经验
发布时间:2019-09-02 09:27:06 | 截止时间:2019-11-19
  • 其他
  • 有经验要求
  • 全职
  • 若干
  • o Provide Technical support and project Leadership to manufacturing sites internal and external to the network, including resolution of technical issues associated with marketed products; assisting in the identification of root causes, developing recommendations and supporting implementations for complex projects on a global scale
    o Provide GMS drug product and fermentation (upstream and downstream) processing expertise and input with regard to preferred process technologies on co-development and launch teams
    o Make decisions on long term objectives, manage associated projects with cross functional representatives and lead team by influence
    o Identify new technologies and set direction and strategy within the area of expertise and related disciplines.
    o Identify and implement continuous improvement of best practices and standard work (Co-Dev, Launches, Transfers) across projects and the organization
    o Analyse and evaluate manufacturing processes to identify process improvements
    o Participate in complex troubleshooting and problem solving activities across the manufacturing network promoting utilization of the DMAIC process
    o Develop innovative concepts and take appropriate risk to successfully complete projects
    o Work with other team leaders on sharing of technical knowledge across the network and encourage others to share knowledge.
    o Recognizes development needs and create development opportunities within the (project) teams
    o Lead the technology transfer of marketed products in support of strategic network decisions
    o Delivering the portfolio of new products to the Commercial organization by co-leading the co-development and supporting/leading launch teams
    o Provide single point of accountability to represent GMS during Discovery and Development phases for new products and new technologies.
    o Provide ongoing technical support on special projects as required by customer and group needs.
    o Participate in due diligence efforts and technical assessment of CMOs to support evaluation of potential sourcing options/changes
    Education and Experience:
    o BS degree in biochemical/chemical engineering or related discipline is required
    o 10 years of industry experience, combination of experience with scaling-up fermentation processes including down stream and technology transfer and drug product manufacturing with a focus on solid oral dosage
    o Minimum of 5 years of project management experience
    o Knowledge of manufacturing facilities and equipment capabilities and constraints
    Familiarity with commercial scale fermentation equipment and processes. This includes:
    Seed scale up, media requirements and sterilization methods, agitation, aeration, DO & pH control, fermentation feeding methods, filtration methods and other processes
    Familiarity with commercial scale drug product equipment and processes. This includes:
    Blending (Ribbon Mixer, Paddle Blender, Bin Blender; etc.), granulation (high sheer and roller compaction), drying (fluid bed and spray), material transfer, and other processes
    o Mastery of scientific principles, practices and theories
    o Skilled in applying statistical methods to fermentation process performance
    Technical Skills Requirements:
    o Effective interpersonal skills. Demonstrated ability to work effectively in cross functional and culturally diverse work environment. The ability to confidently assert a technical position in the face of opposition.
    o Ability to lead and influence a cross functional team
    o Strong understanding of regulatory and quality requirements
    o Proven record of consistent performance
    o Demonstrated capability to effectively apply knowledge, lead multiple activities and balance priorities
    o Commitment to delivering results
    o Demonstrated excellence in planning and organizational skills
    o Comprehensive demonstrated skills in communication (oral and written) – particularly technical writing
    o Comprehensive Microsoft Office skills
    o Willingness to travel, including international travel, as needed (~30%)
  • 本科
  • 不限
  • 外商独资、外企办事处
  • 制药/生物工程
  • 200-499
  • 苏州工业园区同胜路36号