Proclinical is currently recruiting for an Associate Scientist with a biotechnology company located in Durham, NC.
- Execute raw material analytical methods and monitoring technologies to ensure the consistency of company's manufacturing technology platform.
- GMP sample handling and gowning in classified areas to collect and deliver samples to analytical teams.
- Data analysis support for extractable and leachable assessments for single use systems used in manufacturing and new single use system technologies.
- Support raw material monitoring program by conducting laboratory experiments, inputting data into LIMS system and communicating results to analytical lab leadership.
Skills and Requirements:
- BA/BS Biochemistry, Bioengineering, or Chemical Engineering + 0.5-1 yrs relevant
- Basic understanding of cell culture manufacturing processes and experience in anti-sense oligonucleotide and gene therapy manufacturing a plus.
- Experience with elemental metals analysis (ICP-MS or XRF experience a plus) and amino acid and vitamin analysis (HPLC experience a plus) and spectral method analysis (Raman, FTIR etc.).
- Organizational skills suitable for management of multiple priorities and support cGMP Quality systems and processes.
- Comfortable analyzing scientific datasets and experience with process analytics.
- Good communication and project management skills appropriate for execution of projects with other raw material stakeholders.
- Knowledge and understanding of cGMPs and other relevant regulatory standards.
If you are having difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.