Senior Process Development and Formulation Scientist/Engineer
Cellics Therapeutics is seeking to recruit a self-motivated and experienced Senior Scientist for Process Development and Formulation to join our dynamic and collaborative team. The successful candidate will be responsible for formulation and process development, process scale-up and manufacturing activities, supporting the company’s regulatory submissions, and supervising junior scientists/engineers in the department. Cellics offers a highly motivational and rewarding work environment with attractive salary and benefits. Cellics is an Equal Opportunity Employer.
- Carry out the formulation and process development of the company’s proprietary nanoparticle products involving lipids and cell membrane.
- Design and validate new nanoparticle formulations using Quality by Design (QbD) and risk assessment concepts.
- Participate in process scale-up and manufacturing activities to provide quality materials for nonclinical and clinical trials.
- Evaluate and manage tech transfer with contract manufacturing organizations.
- Maintain accurate lab notebooks and complete development reports
- Author and review relevant documents required to support IND and BLA regulatory submissions.
- Author and review production batch records for the manufacturing of GMP materials.
- Supervise/train junior level process and formulation scientists/engineers
- Cooperatively work with personnel in other departments and collaborators: Analytical Development, Quality Assurance and Regulatory Affairs, and collaborating partners.
Requirements and Qualifications:
- PhD in pharmaceutics, industry pharmacy, biochemistry, chemical engineering, biomedical engineering or any equivalent major
- Over 5 years of working experience in biotech or pharmaceutical companies with prior experience in biological nanoparticle formulation and process development (e.g. liposomes, cell-derived materials)
- Good knowledge and understanding of cGMP regulations and ICH guidelines
- Excellent verbal and written communication skills; capable for writing reports and analytical methods
- Team player with ability to positively communicate with team members
- Must be highly organized and able to work independently in a fast-paced environment
- Must be professional, dedicated, detail-oriented, and self-motivated
- Proficiency with word-processing, spreadsheet, chemical drawing, and basic statistical analysis (i.e. MS Word, Excel, ChemDraw, JMP etc.)