What does a process development scientist do?
A process development analyst specializes in designing and developing processes for optimal business performance. Their responsibilities typically revolve around conducting research and analysis to identify the strengths and weaknesses in company operations, identifying company needs and areas for improvement, devising strategies to improve productivity, and coordinating with different departments to gather necessary data. Furthermore, as a process development analyst, it is essential to develop business plans and cost estimates, monitor process implementations, maintain extensive records, and produce progress reports and presentations for clients.
Process development scientist responsibilities
Here are examples of responsibilities from real process development scientist resumes:
- Lead development of ELISA microplate assay for Cardiolipin antibodies
- Improve the cell culture harvest titer without compromising the product quality requirements.
- Execute experiments under FDA, GMP, and GLP standards in order to develop next gen processing and manufacturing procedures.
- Review CMC sections of IND/BLA documents.
- Improve methods/assays and instruments including HPLC.
- Perform product harvest using depth filters and TFF systems.
- Set up and validation of HPLC laboratory for production.
- Participate in robustness studies used for the FDA licensure of Immunoglobulin product.
- Perform various tests including: gravimetric, spectrometric, and wet chemistry.
- Formulate the manufacturing batch records and QC testing procedures for new product introduction.
- Transfer low shear wet granulation products to high shear mixer under FDA require remediation project.
- Design, run and validate experiments to optimize fermentation process in large scale bioreactors in manufacturing.
- Confirm enzyme production via SDS-PAGE, isoelectric focusing and native gel electrophoresis, and enzymatic assays.
- Lead execution of scale up run as a demonstration run, prerequisite for signing contract with CMO.
- Harvest bioreactors for further analysis.
Process development scientist skills and personality traits
We calculated that 10% of Process Development Scientists are proficient in GMP, Data Analysis, and Technical Reports. They’re also known for soft skills such as Communication skills, Observation skills, and Analytical skills.
We break down the percentage of Process Development Scientists that have these skills listed on their resume here:
- GMP, 10%
Assisted in Validation and Qualification of equipment of a GMP manufacturing facility.
- Data Analysis, 7%
Supervised validation/stability batch manufacture in production; Wrote documentation / executed cleaning and process validation sampling / data analysis.
- Technical Reports, 6%
Authored and approved technical reports, SOP, validation protocols and manufacturing instructions.
- Harvest, 5%
Improved the cell culture harvest titer without compromising the product quality requirements.
- CMC, 3%
Participated in CMC meetings to define process development goals for purification department.
- Statistical Analysis, 3%
Collected data and performed statistical analysis using software.
Common skills that a process development scientist uses to do their job include "gmp," "data analysis," and "technical reports." You can find details on the most important process development scientist responsibilities below.
Communication skills. The most essential soft skill for a process development scientist to carry out their responsibilities is communication skills. This skill is important for the role because "medical scientists must be able to explain their research in nontechnical ways." Additionally, a process development scientist resume shows how their duties depend on communication skills: "utilize strong organization, planning, and communication skills to improve process performance and optimize product development efficiencies and timelines. "
Observation skills. Another essential skill to perform process development scientist duties is observation skills. Process development scientists responsibilities require that "medical scientists conduct experiments that require monitoring samples and other health-related data." Process development scientists also use observation skills in their role according to a real resume snippet: "experienced in manufacturing pilot/ pivotal/ exhibit batches following gmp guidelines and also handling observations and qa deviations. "
The three companies that hire the most process development scientists are:
- Amgen36 process development scientists jobs
- Thermo Fisher Scientific21 process development scientists jobs
- FUJIFILM Medical Systems USA17 process development scientists jobs
Choose from 10+ customizable process development scientist resume templates
Build a professional process development scientist resume in minutes. Our AI resume writing assistant will guide you through every step of the process, and you can choose from 10+ resume templates to create your process development scientist resume.
Compare different process development scientists
Process development scientist vs. Quality control analyst
Quality assurance representatives are professionals who are responsible for ensuring the quality of units produced or manufactured is following the standards set by the industry. These representatives supervise the entire production process to identify erroneous methods or tools being used by workers and observing produced for visible defects. They are required to perform various tests to check for the durability of the product and other desirable characteristics. Quality assurance representatives must also collaborate with the manufacturing engineer to implement quality control programs and preparing training manuals and quality guidelines.
These skill sets are where the common ground ends though. The responsibilities of a process development scientist are more likely to require skills like "gmp," "harvest," "cmc," and "statistical analysis." On the other hand, a job as a quality control analyst requires skills like "lab equipment," "microbiology," "lims," and "test results." As you can see, what employees do in each career varies considerably.
Quality control analysts really shine in the manufacturing industry with an average salary of $62,870. Comparatively, process development scientists tend to make the most money in the health care industry with an average salary of $97,873.On average, quality control analysts reach lower levels of education than process development scientists. Quality control analysts are 8.8% less likely to earn a Master's Degree and 12.3% less likely to graduate with a Doctoral Degree.Process development scientist vs. Chemical technician
A chemical technician is responsible for supporting chemists and laboratory technicians in performing laboratory investigations and examining chemical components and structures. Chemical technicians ensure the stability of laboratory tools and equipment, performing proper sterilization and segregation of disposable materials, and maintaining the adequacy of inventory. They also record the research progress, including scientific methods, and write observation reports for reference. A chemical technician manages the cleanliness and orderliness of the facility to avoid potential hazards and complications during chemical operations.
In addition to the difference in salary, there are some other key differences worth noting. For example, process development scientist responsibilities are more likely to require skills like "data analysis," "harvest," "cmc," and "statistical analysis." Meanwhile, a chemical technician has duties that require skills in areas such as "lab equipment," "safety procedures," "hazardous materials," and "osha." These differences highlight just how different the day-to-day in each role looks.
Chemical technicians earn a lower average salary than process development scientists. But chemical technicians earn the highest pay in the pharmaceutical industry, with an average salary of $66,439. Additionally, process development scientists earn the highest salaries in the health care with average pay of $97,873 annually.Average education levels between the two professions vary. Chemical technicians tend to reach lower levels of education than process development scientists. In fact, they're 15.6% less likely to graduate with a Master's Degree and 12.3% less likely to earn a Doctoral Degree.What technology do you think will become more important and prevalent for process development scientists in the next 3-5 years?
Dr. Betsy Smith
Assistant Professor of Chemistry, Elmira College
Process development scientist vs. Laboratory analyst
A Laboratory Analyst helps conduct experiments, run laboratory tests, and analyze results. They compile and record data for the documentation needed for testing and report preparation.
Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from process development scientist resumes include skills like "technical reports," "harvest," "cmc," and "statistical analysis," whereas a laboratory analyst is more likely to list skills in "lab equipment," "lims," "laboratory procedures," and "sample preparation. "
Laboratory analysts make a very good living in the pharmaceutical industry with an average annual salary of $47,806. On the other hand, process development scientists are paid the highest salary in the health care industry, with average annual pay of $97,873.Most laboratory analysts achieve a lower degree level compared to process development scientists. For example, they're 11.8% less likely to graduate with a Master's Degree, and 12.7% less likely to earn a Doctoral Degree.Process development scientist vs. Analytical chemist
An Analytical Chemist uses a wide range of methods to investigate the chemical nature of substances. They analyze samples using different software, techniques, and equipment, and then interpret and report the results.
Types of process development scientist
Updated January 8, 2025
