Position Summary

The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. Thie 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.

Essential Functions (ES) and 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.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements: Bachelor’s 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.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.