Process Development Scientist Job Description Template
Our company is looking for a Process Development Scientist to join our team.
Responsibilities:
- Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups;
- Has technical competency in support of daily operations through research in diverse biological processes;
- Maintains records to comply with regulatory requirements and assists with in-process testing;
- Supports project teams on multiple projects simultaneously;
- Sets up and performs scale down models to assist with process validations and manufacturing investigations, providing analysis as needed;
- Operates and ensures appropriate maintenance of production equipment as it relates upstream production activities;
- Prepares technical reports, summaries, protocols, batch records and performs quantitative analyses;
- Produces proteins using mammalian cell culture to support lead generation/optimization and preclinical studies;
- Operates with minimal supervision on complex systems and equipment;
- Organizes own daily workload schedule and relevant resource requirements;
- Oversees production schedules, materials, equipment and manpower requirements;
- Exercises technical discretion in design, execution and interpretation of manufacturing and production that contributes to project goals;
- Ability to travel domestically and internationally up to 10% of the time;
- Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions;
- Design, plan, execute, and document formulation and process development studies.
Requirements:
- Knowledge of products manufacturing following SOPs, batch records and working within a cGMP regulated environment;
- Knowledge and skill of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization;
- Ability to operate complex systems and equipment and optimize their use in manufacturing in accordance with defined goals;
- Skill and knowledge of scaling up to 500 L or more in single-use technologies;
- Ability to mentor and train purification associates and leads in process transfer, scale-up, from scientific and engineering perspective;
- Knowledge of specific product-related operations in protein purification;
- Ability to organize workload, oversee direct reports, and relevant resource requirements;
- MS degree in applicable scientific field, PhD degree preferred;
- Strong problem solving and effective cross-functional communication skills;
- Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up;
- Doctorate degree or Doctorate degree completed by February 2020;
- Experience with data visualization tools or packages, such as Tableau or Spotfire;
- Good organizational skills with strong attention to detail;
- Strong ability to operate well in a fast-paced, matrix environment and collaborate successfully cross-functionally;
- Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab).