Senior Scientist, Production Operations

Role Summary

Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. The role will drive and/or coordinate process improvements, utilizing the quality system as required. Generate and analyze trend reports on production processes (both in-process and FIN) as needed and track effectiveness of changes. Support a strong cGMP environment.

Responsibilities

• Develop subject matter expertise in biologic protein fractionation, purification, and fill finish technologies to support Production Operations.
• Technical lead for all departmental projects, change controls, risk assessments, deviations, CAPAs, and audit support.
• As needed provide data/analysis to support groups including: MQA, PD, Regulatory Affairs, Microbiology, Engineering and Validation.
• Utilize project management skills to track progress of projects to ensure milestones are met.
• Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set and communicate status on a routine basis.
• As needed analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control.
• Support the development of training strategies and materials for manufacturing and support teams as needed.
• Work closely with department leaders and peers and interfaces to fill in for leaders and peers as required.
• Partner with support functions to continuously improve safety and quality to meet ADMA goals.
• Stay current on industry trends.

Qualifications

• Education Requirements: Bachelor‚Äôs degree in science, engineering, or another related technical field preferred
• Experience Requirements:
  • 10+ years of experience in Plasma Fractionation or Purification or Fill Finish Operations
  • Experience in all aspects of Manufacturing preferred
  • Knowledge of world-class manufacturing methods (QLP, Lean, Six Sigma), DMAIC, Good Manufacturing Practices, Food and Drug Administration regulations
  • Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels.
  • Must be able to work and facilitate a team-orientated environment.
  • Must have demonstrated project management skills and/or project delivery skills.

Skills

• cGMP adherence
• Strong organizational, interpersonal and collaborative skills
• Data analysis and interpretation
• Project management and cross-functional collaboration

Education

• Bachelor‚Äôs degree in science, engineering, or another related technical field (preferred)