Title:  Sr. Scientist

Job Title

Senior Scientist (EM)

FLSA

 Exempt

Summary

This position is responsible for the oversight of workflow in the Environmental Monitoring (EM) group and the accuracy of test results and raw data generated.  The qualified candidate must possess detailed knowledge with regards to environmental monitoring requirements in ISO 5/7/8 classified rooms, media fill trials, clean room qualifications and airflow pattern analysis (smoke studies).  The qualified candidate must have experience interacting with the FDA and other regulatory/audit groups.  This position will be responsible for ensuring timely completion of EM result reports, writing/revising standard operating procedures, forms, protocols, trending reports, change controls, investigations as well as providing guidance to less senior staff and functioning as a backup for supervision/management when necessary.

Essential Duties and Responsibilities

1. SME for all EM tasks. Facilitate the workflow of the EM staff by planning, organizing and directing the activities of the group.  Ensure adequate supplies and equipment are available for monitoring.  Prepare metrics and make recommendations to improve productivity and efficiency of the EM group.
2. Ensure compliance to policies and procedures by examining the accuracy of all records and documentation.  Confirm that team members are trained and proficient before allowing them to perform tasks.  Review laboratory records for accuracy, completeness, compliance, and conformance to specifications.  Approve laboratory records and ensure initiation of quality event reports and investigations as required.  Ensure the EM group is always prepared for both internal and external audits.  
3. Responsible for the smoke study program.  Coordinate all smoke study activities, write smoke study protocols and summary reports, review video footage and ensure acceptance criteria are met.  Present summary reports as well as video footage to auditors upon request.
4. Prepare and/or revise SOPs to ensure compliance with regulations and current practices.  Keep current on regulations and industry best practices pertaining to the group and update SOPs to improve compliance.  Prepare and execute change controls as needed to support changes to the program and/or facility.
5. Work independently in areas needed, provide guidance to less senior staff and function as backup for supervision/management when necessary.
6. Write quality event reports/laboratory investigations/memos for deviations. Execute appropriate investigative testing to find or support root cause and determine the impact of the deviation.  Develop and implement appropriate corrective and preventative actions to eliminate repeat occurrences.
7. Participate on teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

Qualifications

1. Must be recognized by all levels of the facility as an expert in EM and be able to demonstrate leadership.
2. Excellent organizational and project management skills.
3. Must have excellent writing skills and ability to present data in a logical manner.
4. Good interpersonal, communication, influencing, leadership, and negotiation skills.
5. Understand scientific principles and be able to invent new methods or new avenues of investigation.
6. Demonstrated effectiveness in task completion, decision making, and problem solving.
7. Working knowledge of FDA regulations, application of GLPs and cGMPs).  Experience interacting with personnel from regulatory agencies preferred.
8. Must be able to pass and maintain Class 100/ISO 5/Grade A gowning qualification.

Education and/or Experience

BS/BA in Biology or Microbiology. Must have 6 years of pharmaceutical environmental monitoring or operations experience.  Experience with parenteral/aseptic manufacturing required. Experience with Novatek preferred.