Manufacturing Scientist Job Summary
The Manufacturing Scientist will be responsible for the manufacturing and testing of reagents and controls for an in vitro diagnostics Point of Care (POC) system in a highly regulated GMP/GLP setting under the direction of a Supervisor or Scientist. Additionally, this position will support development of new reagents, laboratory upkeep, and other duties as defined by the supervisor. Job Responsibilities
Education & Qualifications
- Manufacture and test in vitro diagnostics reagents and controls following established procedures under the direction of a Supervisor or Scientist.
- Conduct activities in compliance with laboratory safety, good laboratory practices, and design control requirements.
- Manufacture and test reagents and controls following established procedures. Must be able to accurately and carefully maintain documentation as required under the regulated environment of design control.
- Maintain and execute reagent and control stability studies.
- Execute process validation and equipment validation studies.
- Evaluate and troubleshoot performance of reagents and formulations.
- Assist in executing process improvement studies to support formulations.
- Provide support for special topics and problems that arise, as assigned and directed by the Supervisor or Scientist.
- Support design changes and improvements under the direction of Supervisor or Scientist.
- Assemble and analyze data, and summarize results, as directed.
- Conduct protocol driven testing for process validation, equipment qualifications, and other improvement efforts.
- Other programs as identified by the Supervisor.
- Bachelor's Degree in medical technology, or scientific, or engineering discipline required.
- Minimum of 2 years' experience in medical device industry.
- Experience in a manufacturing environment or Quality Control testing environment of in vitro diagnostics and/or coagulation laboratory products desirable.
- Competence working with Microsoft Office, particularly Word and Excel.
- Familiarity with statistical software desirable.
- Training and education in a scientific field.
- Must be able read and understand written instructions, and maintain detailed documentation.
- Strong organizational skills and attention to detail are crucial for success in this position.
- The ability to ask appropriate questions and follow direction to execute complex protocols for all studies.
- Effective analytical, quantitative, and problem solving skills.
- Strong written and verbal communication skills
- The ability to work in a team driven environment
- Training in laboratory safety practices: Bloodborne Pathogen, Hazardous Chemicals, PPE, Universal precautions, etc.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.