Scientist-Clinical Trial Sterility Assurance

June 14 2017
Life Sciences
Position Type
Full Time
Organization Type
Job Type
A scientist in Clinical Trial Sterility Assurance encompasses technical leadership and advisory with regard to sterility assurance technologies and strategies employed within Clinical Trial Parenteral Manufacturing. In this role, you will develop of the CT sterility assurance program and long term stewardship, including assessment of and improvement of existing controls over time. You will have the opportunity to develop a cleaning program supporting the CT parenteral operations and subsequent ownership of the cleaning program. In this role, you will experience opportunities such as:
  • Use of risk-based approaches to develop and implement parenteral clinical trial manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
  • Identification of aseptic manipulations and interventions and associated controls in parenteral processes and use of risk-based approaches to evaluate their acceptability.
  • Develop, implement, and subsequently maintain cleaning program
  • Execution of risk-based approaches to identify areas of highest risk in support of sampling location selection in Environmental Monitoring Performance Qualification protocols and eventual identification of routine EM sampling sites.
  • Leads site aseptic checks self-inspection program including sharing of observations and recommendations to Operations and the Site Sterility Assurance Strategy Team.
  • Leads or provides consultation for investigation of sterility assurance and cleaning process related events and non-conformances.
  • Evaluate and identify consumable items used in aseptic processes and lead investigation of issues associated with their use.
  • Develop / maintain site programs for training and qualification of aseptic personnel
  • Represent / defend site sterility assurance strategies during internal assessments / audits and external regulatory inspections.
  • Leads complex projects associated with sterility assurance strategies
  • Stays abreast of external regulatory requirements associated with sterility assurance, including active participation in relevant external technical forums (i.e. Parenteral Drug Association).
  • Provides mentorship to peers of the CT manufacturing group
  • Influences creation of / changes to corporate guidance associated with sterility assurance.
  • Provides sterility assurance training for new hires and personnel from other sites.
Basic Qualifications
  • Bachelors Degree in Microbiology, Biology or related scientific field
  • Experience in sterility assurance supporting a parenteral plant, at a minimum of 5 years
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/Preferences
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and PRD Goals.
  • Understanding of GMPs and applicable internal standards
  • Technical writing and presentation skills.
  • Interpersonal skills including the demonstrated ability to effectively influence others including leadership.
Additional Information
  • 8 hour days - Monday through Friday
  • Overtime may be required
  • 5-10% Travel Required
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.