Process Scientist Job Description

Process Scientist Job Description

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Process scientist provides technical expertise within one of the process areas such as cell culture, protein purification, filtration, etc.

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:

Document experimental findings through periodic authorship of progress reports that will be included in dossiers for product registration and technology transfer
Design, execute experiments and analyze data under limited supervision to support make data driven decisions
Lead limited scope projects or serve as an integral member of project team tasked with resolving technical issues or continuous improvement projects utilizing six sigma and lean manufacturing
Review proposed engineering / manufacturing process changes and assess the risk of these changes to the equipment and product
Experienced investigating and implementing effective solutions to customer complaints, products out of specification and to technical product issues consistent to QSR, ISO and cGMP guidelines
Work effectively within cross-functional teams (regulatory, quality, Research & development and operations) as an active representative of the Product Support Group and contribute to reach assigned goals
Good communication skills including data and results presentation to team members and leadership
Proficient with MS office suite is necessary and experience with Minitab or other statistical software will be a plus
Expand the reach of the GH and the Leaders of SEP and the group’s overall effectiveness by maintaining contact/dialogue with key stakeholders
Lead process development efforts

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:

Downstream purification of mAbs highly desired
Experimental design
Chemical process modeling
Statistical tools
Timely resolution of product / process technical issues
Operational equipment
Cell biology
Chromatography and virus filtration techniques
Technology transfer
Microsoft Excel

Desired experience for process scientist includes:

Candidates will have background in chemical engineering, biochemical engineering, microbiology, or relevant biological sciences
Technical knowledge and experience on development of CHO and/or E
Knowledge and experience working in a cGMP environment
Ability to organize and prioritize work schedules of others on short and long-term bases, including integrating timelines, devising batch records and meeting milestones for successful project completion
Ability to formulate complex and comprehensive materials such as authoritative reports and/or to make formal presentations
Ability to compute, analyze, and interpret complex statistical data

Process Scientist Examples

1

Process Scientist Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of process scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for process scientist
  • 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
Qualifications for process scientist
  • 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
2

Process Scientist Job Description

Job Description Example
Our company is growing rapidly and is hiring for a process scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for process scientist
  • 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
Qualifications for process scientist
  • 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
3

Process Scientist Job Description

Job Description Example
Our company is looking to fill the role of process scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for process scientist
  • 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
Qualifications for process scientist
  • 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)
4

Process Scientist Job Description

Job Description Example
Our innovative and growing company is hiring for a process scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for process scientist
  • 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
Qualifications for process scientist
  • 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
5

Process Scientist Job Description

Job Description Example
Our company is hiring for a process scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for process scientist
  • 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
Qualifications for process scientist
  • 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

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