Job Title:Cell Culture Supervisor

FLSAStatus:Exempt

Job Responsibilities:

This individual will lead and perform upstream cell culture related activities. This includes media preparation, master cell banking, small-scale production activities using WAVE and Bioreactor technology, both fed-batch and perfusion. The individual will verify and ensure that proper processes and procedures are followed in accordance with SOPs while supervising a small team (1-2) of Biotechnicians. The team is responsible for providing mammalian cell culture services to various business units within SDIX. They will also assists with facility and project planning with in the cell culture team.

Responsibilities and Duties:

  1. Directly supervises invitroproduction of biological products according to SOPs, customer specs and quality standards, meeting deadlines, production goals and assisting in production activities as needed.
  2. Generates reports and documents, provides technical assistance and associated information insupport of internal and external clients for product manufacturing.
  3. Communicate all aspects of project with department head both orally and written (i.e. monthly report).
  4. Supervision of manufacturing personnel, to include scheduling of work activities, completion of performance reviews, conducting coaching sessions, control of overtime, approval and submission of time cards and related supervisory tasks.
  5. Revise SOPs to maintain compliance to cGMP regulations, train staff, evaluate and implementsystems, document progress, advise management, and perform related tasks.
  6. Maintain product/material inventories, segregation of products,and other supplies.
  7. Plan, direct and assist with creation and expansion of products and productioncapacities for increased revenue generation.
  8. Maintain a clean, organized and safe work environment.
  9. Assist with project planning, to include researching and evaluating equipment, materials and products, testing prototypes, collecting data, evaluating and advising on business opportunities, obtaining process improvements, and related tasks.
  10. Must demonstrate skills in multitasking, organizational management, attention to detail, interpersonal, communications, judgment, Planning & prioritizing, Recognizing cause and effect. Interpret Instructions, Problem solving
  11. Provide leadership to team including scheduling, training, coaching and conducting performance reviews.
  12. Perform all additional job duties necessary within manufacturing areas as assigned.

Qualifications:Knowledge, Skills and Abilities: Education, Experience, Job Skills, Equipment Skills, and Certifications)

  1. Four year science related degree and 4-6 years related experience.
  2. Understand laboratory safety standards.
  3. Knowledge of lab services related SOPs.
  4. Knowledge of cGMP related regulations.
  5. Working knowledge of mammalian cell culture methodology (ideally hybrdoma cells).
  6. Working knowledge of WAVE bag technology and/or small-scaleBioreactor units.
  7. Good written and verbal communication
  8. Mathematical proficiency in laboratory calculations.
  9. Use of related laboratory equipment (hood, pipette, pH meter, etc.)

Supervisory Responsibilities:

Supervises a team of Biotechnicians / Technicians, providing on-going training, leadership, coaching and conducting quarterly and yearly performance reviews.

Work Environment / Other Requirements:

At SDIX LLC our work environment varies significantly from job to job. Ability to lift or move 50 pounds and work/travel throughout plant environment of varied temperatures and humidity; grasp and hold small objects, a full range of motion, and to wear personal protective devices. This position may expose the employee to fumes or airborne particles, biohazards, and toxic or caustic chemicals. Daily contact with employees in other departments is required.