Sr. Manager, Pre-clinical Manufacturing (Upstream)

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.<br><br>The Senior Manager, Pre-Clinical Manufacturing reports to the Head of Pre-Clinical Manufacturing and is responsible for organization, management, and development of pre-clinical manufacturing operations and processes at the Technical Research and Development site. <br><br>What you'll be doing:<br>• Directly responsible for a team of Process Science Engineers whose responsibilities include the production of pre-clinical material, large scale development work and support of small scale lab experiments, as needed.<br>• First line of contact to address process, equipment, or safety related issues in the lab environment.<br>• Oversite for one of the following: Upstream (cell culture), or Downstream (purification) activities in the large scale development team. <br>• Produce pre-clinical material on an annual basis that meets the site’s strategic objects and is compliant with phase appropriate requirements, the Development Quality Plan and safety regulations.<br>• Perform a technical review, close out and archival of development batch records. <br>• Author, review or contribute to run summary reports for large scale development or engineering runs.<br>• Partners with small scale development teams to design and conduct experiments to support the development and implementation of a cell culture scale-up, recovery, and downstream purification processes for the product pipeline.<br>• Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.<br>• Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions and recommending options for future experiments to achieve project goals.<br>• Schedule daily operations (finite scheduling) for manufacturing unit operations as well as media/buffer preparation activities. <br>• Ensure resources are adequate to complete operations for both raw materials and personnel. <br>• Work with procurement to provide required bill of materials and ensure accurate material purchasing for upcoming pre-clinical batches.<br>• Identify process challenges based on unique consumable needs. Work with vendors to design custom solutions, as needed.<br>• Works cross-functionally to ensure accuracy of large scale batch sampling plans, sample pulling and sample submission to the analytical sample management team.<br>• Lead troubleshooting and investigations as related to process issues at scale. Partner cross-functionally with stakeholders from Early Development, Engineering, Analytical, Procurement and Quality to address these issues effectively and compliantly.<br>• Ensure documentation (batch records, work instructions, PLANs and SOPs) are accurate and updated as required.<br>• Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.<br>• Provide monthly manufacturing metrics as determined by management.<br>• Lead areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects.<br>• Identify and implement continuous improvement opportunities. <br>• Lead and mentor staff. Facilitate the professional development of each team member. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.<br>• Champion for all EH&S policies, procedures and guidelines. Drives a safety first culture within the team.<br>• Other related job duties as assigned.<br><br>[#video#https://youtu.be/ggbnzRY9z8w{#400,300#}#/video#]