Position: Analytical Scientist/Senior Analytical Scientist
Cellics Therapeutics Inc. is a rapidly growing biotech company located in San Diego. Cellics focuses on the development of novel therapeutics based upon biomimetic cell membrane coated nanoparticles. Cellics offers a highly motivating and rewarding working environment with attractive salary and benefits and is an Equal Opportunity Employer.
Cellics is looking for an analytical scientist or a senior analytical scientist (title and pay commensurate with experience) with strong scientific background in a range of assays along with an excellent understanding and technical proficiency with analytical technologies and extensive experience in the assessment of technical data to support our QC group. The ideal candidate should be a self-motivated creative problem solver and can deal with ambiguity and declare a path forward to achieve results. The new hire will report to Manager of Quality Control.
Essential Duties and Responsibilities:
The new hire will work on establishing cGMP compliant QC labs to support preclinical development and clinical development programs. Specific tasks include but are not limited to the following:
- Develop and qualify analytical methods used for release test of raw materials, in-process materials and final drug substance and drug products;
- Perform analytical testing of raw materials, in-process materials and final drug substance and drug products;
- Perform characterization testing to assist Process Development group;
- Analyze and document results promptly and author protocols and reports;
- Evaluate and purchase analytical instruments;
- Assist in evaluating suppliers for raw materials and contract testing laboratories;
- Regularly report work status and prepare written reports on work performed;
- Help prepare CMC documents required for regulatory filing;
- Cooperatively work with personnel in other departments/collaborators: Process Development, Pharmacology, Quality Assurance and Regulatory Affairs, and collaborating partners.
- Master or PhD in the biology, analytical chemistry, bioanalytical chemistry, molecular biology, cell biology or any equivalent major.
- Over 4 years of experience in biotech or pharmaceutical companies.
- Hands-on experience on multiple analytical instruments for chemical and biological compounds, such as IR, HPLC, Particle size analyzer, Plate-based assays, cell-based assay, pH meter, and etc.
- Prior experience with analytical method development and qualification/validation for preclinical and clinical development projects
- Hands-on experience on USP tests and understand USP monographs is a plus
- Knowledge and understanding of cGMP regulations and ICH guidelines.
- Background knowledge and technical skills in nanotechnology and nanoparticle testing is a plus.
- Excellent verbal and written communication skills
- Experience in writing reports and analytical methods
- Team player with ability to positively communicate with team members
- Highly organized and able to work independently in a fast-paced environment under limited supervision
- Professional, dedicated, detail-oriented, and self-motivated
- Proficiency with word-processing, spreadsheet, and basic statistical analysis (i.e. MS Word, Excel, JMP etc.)
Please send CV to firstname.lastname@example.org to apply.