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%)