Process Scientist Job Description
Process Scientist Duties & Responsibilities
To write an effective process scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included process scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Process Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Process Scientist
List any licenses or certifications required by the position: PMP
Education for Process Scientist
Typically a job would require a certain level of education.
Employers hiring for the process scientist job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Chemistry, Engineering, Chemical Engineering, Biochemistry, Science, Biology, Biotechnology, Manufacturing, Education, Life Sciences
Skills for Process Scientist
Desired skills for process scientist include:
Desired experience for process scientist includes:
Process Scientist Examples
Process Scientist Job Description
- Research and develop safe, efficient, and scalable processes for drug development programs
- Research and develop novel and cost effective processes using innovative approaches such as chemoenzymatic synthesis, biocatalysis, and green chemistry principles
- Review preparative methods with the laboratory team, and to confirm process operations will transfer to production at scale
- Co-ordinate and gather information from the project team in the event of process failure
- Design, execute experiments and document under limited supervision
- Lead limited scope projects or serve as a member of project team tasked with resolving technical issues or continuous improvement projects
- Lead low- and medium-complexity projects independently and make contributions to new product development project teams
- Document new production and QC processes and train manufacturing personnel
- Participate in the verification and validation of new process improvements
- Perform troubleshooting relating to product quality and manufacturing process issues
- Comprehensive hands-on practical experience with systems for monoclonal antibody expression in CHO cells, recombinant protein expression in prokaryotes, or in yeasts
- PhD in Biotechnology, Biochemistry, Chemical Engineering or a related field with 3+ years experience
- A degree or PhD
- Comprehensive hands-on practical experience with systems involving cultivation of wild type micro-organisms, yeasts, or prokaryotes for recombinant protein expression
- Knowledge of the regulatory (USDA, FDA, EMA) expectations for bioprocess design and technical transfer in alignment with principles of GMP
- Fresh PhD with years related working experience is a plus
Process Scientist Job Description
- Support technology transfer projects for the filling operations
- Investigates, troubleshoots, and identifies corrective actions for short and long term manufacturing process and/or product technical issues
- Leads or provides technical support to proejcts teams tasked with technical issue resolution, continuous improvement initiatives, product transfer, process and formulation optimization
- Develops and executes project planes within required timelines
- Collects, records, analyzes, interprets, and reports experimental data in a manner consistent with QSR/ISO guidelines
- Effectively presents projects and data to team members and leadership
- Applies expert knowledge in scientific/engineering theories to execute overall project assignments
- Conceptualizes, prioritizes and schedules project deliverables
- Interprets experimentation results to determine appropriate course of action
- Develops and/or directs experimentation
- Hands-on Laboratory/pilot or manufacturing skills in downstream process such as centrifugation, depth filtration, chromatography, viral filtration, tangential flow filtration
- Six sigma certification and a working knowledge of applied statistical analysis to manufacturing
- Demonstrated ability to transition research protocols to production SOPs in a stage-gated development process
- Minimum of MS degree in chemistry/material science/chemical engineering with 10 years of industry experience in process development or Ph.D in chemistry/material science with minimum 6-8 years of industry experience in process development
- Master’s or Bachelor’s Degree in Biotechnology, Biological Engineering, Biomanufacturing or related field with 10 years of industrial experience
- Requires PhD in Chemical, Biochemical Engineering or a related field with 0-2 years’ experience in biopharmaceutical industry
Process Scientist Job Description
- Summarizes relevant work into written reports that synthesize experimental results into a working hypothesis and details future plans
- Establish and implement SOPs for manufacturing process, manufacturing equipment, assays and troubleshooting protocols
- Prepare and deliver scientific presentations internally and externally
- Interface with other departments, other facilities and corporate partners to facilitate product development
- Is responsible for the general upkeep and maintenance of sophisticated laboratory equipment and facilities
- Participates in the hiring, supervision, development and performance reviews of Scientists I, II and Senior Scientists
- Responsible for a broad range of unit operations
- The candidate will also contribute to development, scale up and transfer of cell culture and purification processes to GMP Production, continuous process improvement
- She/he is expected to keep excellent laboratory records
- Performing microbial fermentation process development experiments for the development of new manufacturing processes and the improvement of existing processes at lab and pilot scale, including all upstream and primary recovery activities associated purification and analytical methods
- Prior knowledge of GLP and/or GMP environments and systems
- High focus on quality and safety
- Good communication and strong personal and interpersonal skills
- Self motivated with initiative and drive
- Good standard of written and spoken English and computer literacy
- Support Manufacturing efficiency and operations projects by interfacing with all internal departments (Quality Assurance, Engineering, Information Technology, Validation, Manufacturing, Planning, Supply Chain Management)
Process Scientist Job Description
- Work with the Applied Cell Biology and Transformation Platforms to systematically identify key bottlenecks in current systems that limit overall productivity
- Trend and analyse laboratory data and present results to line manager, USP team and at internal meetings
- Reviewing, writing and updating internal procedures and documents and to the maintenance and housekeeping of a safe laboratory working environment, including contribution to writing and reviewing HSE risk assessments related to USP activities
- Ensure that SOP’s are applied
- Record training for procedures
- Notify QA about any deviation
- Carry out corrective actions
- Design, carry out and complete routine and exploratory experiments generally without supervision
- Start to develop understanding of API development issues outside of Chemical Development
- Identify areas that need improvement and help implement changes
- Experience with innovation and operational excellence is desirable
- Requires PhD in Biology, Biomedical Sciences or Chemistry or a related field with 0-2 years’ experience
- Experience with Synthetic Chemistry and/or Medicinal Chemistry a plus
- Possesses advanced laboratory skills
- Displays organizational skills and ability to prioritize personal tasks to meet deadlines
- Efficiently works in a team-based environment to meet goals
Process Scientist Job Description
- Effectively communicate own work in oral or written forms in the context of team goals
- Demonstrate understanding of individual goals within the context of overall project goals
- Participate in training of technicians and junior scientists in area of expertise
- Good knowledge of process economics, timelines, environmental (green chemistry) and process safety issues
- Complies with applicable regulations (NRC if radiosynthesis), performing all work in a safe manner
- Evaluate chemical reactivity hazards using techniques such as reaction calorimetry, online analytics, and batch process modeling tools
- Plan, execute, and document cGMP and “GLP-like” laboratory work supporting regulatory submissions and patent prosecutions
- Solid understanding of organic chemistry principles
- Significant experience in process development for small molecules at various scales (miligrams to kilograms)
- Experience with literature search tools such as Scifinder and Reaxys
- CGMP, CHO and cellular metabolism experience are desirable
- Proficient with the use of FPLC hardware and Unicorn and MS Office software
- Bachelor’s degree in Metallurgy, Material Science, Mechanical Engineering or Chemical Engineering or other relevant degree
- Ability to read and understand software programming languages such as Fortran, C, Java and C#
- Knowledge of steel making processes as an integral part of this highly skilled, innovative team, you will play a significant role in providing critical services to our production operations
- Degree in biologic sciences, engineering or other relevant discipline