- The Scientist I, Production Molecular Biology must comprehend and perform scheduled routine and complex bulk formulation production tasks according to established procedures in accordance with applicable regulations; support general laboratory maintenance including material and instrument upkeep and work environment improvements.
- Build technical skills, production skills and understanding of the theory behind protocols; make detailed experimental observations and process data.
- Support of Production through purification of monoclonal antibodies and other proteins.
- Purification of novel and existing protein reagents using IEX, SEC, and affinity chromatography.
- Accurately complete all production-related documentation and labor reports and demonstrate higher throughput over time.
- Characterization of protein bioactivity and purity using ELISA and cell-based assays.
- Generation of cell culture supernatants for purification of monoclonal antibodies and proteins.
- Provide guidance to other associates with regard to daily production tasks.
- Communicate issues and discrepancies that may affect quality, accuracy and usefulness of data to supervisors.
- Participate in reviewing documentation, writing/updating SOPs/specifications and with corrective actions or process improvements.
- Contribute to and support department/corporate goals.
- Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MDD, IVDD, EU-PSHA, OSHA, etc.).
- Bachelors degree in a scientific discipline or equivalent with 3-5 years of related work experience; 1-4 years with M.S.
- Demonstrated knowledge of commonly used technical concepts, practices and procedures.
- Able to independently follow production protocols and resolve problems with general instruction.
- Able to use general laboratory equipment; familiarity with computers and basic MS Office applications.
- Able to plan the use of equipment, materials and personal time efficiently.
- Able to complete production-related documentation accurately and prepare rudimentary technical summaries.
- Has a working knowledge of experimental design.
- Able to work safely and effectively in a team environment.
- Organization and attention to detail skills.
- Able to communicate issues and problems to supervisors.
- Working Environment: May require work with potentially biohazardous and/or chemically hazardous materials. The work environment is fast-paced.
- Physical Requirements: Must be able to lift up to 50 lbs.
- Lifting Requirements: Medium work (exerting up to 50 pounds of force).
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.