Senior Scientist, Parenteral Operations MST

Senior Scientist, Parenteral Operations MST

Job Title: Senior Scientist, Parenteral Operations MST

Department: Manufacturing

Location: Bloomington, IN (Onsite)

The Senior Scientist, Parenteral Operations MST serves as a group leader and technical expert responsible for transfer activities leading to a robust and reliable manufacturing of selected parenteral product presentations using client's manufacturing technology platform. Together with his/her team, will advance and deploy manufacturing sciences expertise for end-to-end parenteral operations for formulation, filling, and inspection lines. Serves as technical parenteral operations resource for internal parties.

This role’s objectives include analyzing equipment/process data, monitoring production metrics, authoring and executing protocols, and serving as a technical asset for process improvement and root cause investigations. This role is expected to interface regularly with the manufacturing operations and engineering teams in support of day-to-day operations.

The following key functions will be carried out in accordance with the company’s vision, mission, standards, goals, objectives, and strategic direction.

• Ensure phase appropriate transfer and scale up/scale down for clinical material from clients to internal manufacturing platforms
• Assist in leading and ensures the success of new process and product presentations into manufacturing.
ures 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
• 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.

Characteristics Required Include:

• Demonstrated proficiency and experience with pharmaceutical sterile process development and fill/finish…