· Ensure phase appropriate transfer and scale up/scale down for clinical material from Singota’s clients to internal manufacturing platforms

· Assist in leading and ensures the success of new process and product presentations into manufacturing.

· Ensures that technology transfer documentation is completed timely and enables flawless execution. Drives the implementation of continual improvements documents associated with process transfer to manufacturing. Coordinates timely “Lessons Learned” reflecting and leveraging acquired outcomes to future activities

• Prepare and Review, as required, relevant technical documents, such as: Batch Records, Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFMEAs, etc.
  
  
• Performs assessments of incoming product and process knowledge available in scope of new technology transfers
  

· Provide input and requirements to drug product development in relation to materials in direct product contact (i.e single use materials, primary container closure systems)

· Support investigations, CAPAs, change controls according to assigned responsibilities and perform critical raw data review for key document.

· Assist in assess new technologies/applications: feasibility, business case, conceptual design, installation and implementation.

· Evaluates the required resources and timing necessary to execute clients’ studies. Designs process characterization studies and leads the team to complete execution of agreed upon work and milestones.

· Participates to knowledge generation and integration across R&D and Ops activities. Shares acquired knowledge internally and during client meetings

· Establish metrics on tasks, performance, and status of deliverables for Technical Operations activities. Performs data analytics to convert results into knowledge, provide useful and easy to use structured information than transferred into clients reports.

· Functions as department’s Parenteral Manufacturing Science subject matter expert. Leads and grows a team focused on support to manufacturing and prepares instructions and documents required for product manufacturing. Mentor scientists, MS&T and process engineers

· Performs standard supervisory duties assigned by Human Resources, including but not limited to mentoring employees,

· Supports Business Development and Client Services on new and repeat business.

· Assist in providing ongoing support for building executable protocols, documenting with accuracy, execution and summarizing study outcomes. Shares results and outcomes internally and to clients.