Process Development Scientist – Pivotal Drug Product Job Description Template
Our company is looking for a Process Development Scientist – Pivotal Drug Product to join our team.
Responsibilities:
- Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software;
- Deliver progress reports and presentations to management on technical challenges, proposed solutions and results;
- Author and review regulatory sections in support of IND and marketing application submissions;
- Execute and document laboratory studies with a high degree of technical rigor;
- Author and review guideline documents, technical protocols, and reports;
- Ability to travel domestically and internationally up to 10% of the time;
- Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline and lifecycle management programs;
- Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and milestones.
Requirements:
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related discipline;
- Proven ability to learn and act on dynamic information at a rapid pace;
- Experience with data visualization tools or packages, such as Tableau or Spotfire;
- Experience with coding/scripting for automated data analysis and modeling;
- Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up;
- Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products;
- Strong problem solving and effective cross-functional communication skills;
- 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field.