Senior Process Development and Formulation Scientist/Engineer

Location
San Diego, California
Salary
Attractive Salary and Full Benefits
Posted
Jan 16, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

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. 

Primary Responsibilities:

  • 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.)