This role is to perform analytical testing in a cGMP environment
This position is responsible for the following:
- Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
- Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
- Complete testing in a timely and appropriate manner.
- May maintain inventory/supplies necessary to conduct routine testing
- Performs equipment maintenance and calibrations as required.
- Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
- Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
- Investigate and write exception (e.g. deviations and OOS) documents.
- May perform other duties as assigned.
Job Qualifications and Skills:
- Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.
- Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
- Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
- Experience with setting up and successfully managing cell-based assays is highly preferred.
- Education, training, or experience in cell therapy a plus.
- Proficient in MS Office, Visio, Project, and statistical software.
- Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
- CELL CULTURE EXPERIENCE A MUST