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Process development scientist skills for your resume and career

Updated January 8, 2025
7 min read
Quoted experts
Rev. Grace Song,
Rev. Grace Song
Below we've compiled a list of the most critical process development scientist skills. We ranked the top skills for process development scientists based on the percentage of resumes they appeared on. For example, 10.1% of process development scientist resumes contained gmp as a skill. Continue reading to find out what skills a process development scientist needs to be successful in the workplace.

15 process development scientist skills for your resume and career

1. GMP

GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.

Here's how process development scientists use gmp:
  • Assisted in Validation and Qualification of equipment of a GMP manufacturing facility.
  • Authored batch production records and directly supervised GMP processing.

2. Data Analysis

Here's how process development scientists use data analysis:
  • Supervised validation/stability batch manufacture in production; Wrote documentation / executed cleaning and process validation sampling / data analysis.
  • Conducted the development activities (design of experiment) and data analysis with the statistical software like JMP.

3. Technical Reports

Technical reports are a type of document that is used to indicate either the progress, result, or process of scientific research or the state of problems occurring within such research. A technical report may also showcase the report's overall conclusion and may also include recommendations. This kind of report does not require a peer review and isn't published officially but distributed within the organizations where it was formed.

Here's how process development scientists use technical reports:
  • Authored and approved technical reports, SOP, validation protocols and manufacturing instructions.
  • Documented the details of each experimental operation, analyzed and interpreted data, and wrote technical reports.

4. Harvest

Here's how process development scientists use harvest:
  • Improved the cell culture harvest titer without compromising the product quality requirements.
  • Operated continuous centrifugation, depth filtration and microfiltration during pilot scale cell culture harvest.

5. CMC

CMC stands for "chemistry, manufacturing, and controls," which represents a standard procedure when producing new pharmaceutical drugs. First the drug is developed through chemical tests and analysis, then the drug is manufactured. Before the pharmaceutical can be offered to the public, it must be tested on individuals, often animal test subjects first and then human beings. This allows pharmacists to determine whether the drug must be reconsidered, reproduced, or whether any side effects accompany the drug.

Here's how process development scientists use cmc:
  • Participated in CMC meetings to define process development goals for purification department.
  • Authored several Formulation CMC documents for IND and EMA submissions.

6. Statistical Analysis

Here's how process development scientists use statistical analysis:
  • Collected data and performed statistical analysis using software.
  • Collect and analysis data; use JMP to perform statistical analysis as needed.

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7. Tech Transfer

Here's how process development scientists use tech transfer:
  • Involved in final stage R&D, scale-up, process optimization, tech transfer/training, and process validation activities.
  • Work in collaboration with Operations group to execute protocols, experimental plans, critical production batches, and tech transfers.

8. Analytical Methods

An analytical method is a method used to determine the chemical or physical property of a substance. It is a procedure to determine the relationship between different variables. This method can be conducted by combining scientific methods with any kind of formal process to solve a problem or prove a fact.

Here's how process development scientists use analytical methods:
  • Develop analytical methods for analyzing, qualifying and troubleshooting incoming raw materials, in-process intermediates and prototype reagents/products.
  • Characterized degradation products, developed analytical methods and conducted method validation.

9. Product Quality

Product quality is the basic element of a business. It means to add features in a product or service in such a way that it meets the needs and wants of the customers. Enhancing the product quality also means improve the goods from any existing defects to ensure customer satisfaction.

Here's how process development scientists use product quality:
  • Accepted challenge to optimize performance of manufacturing processes by improving product quality, increasing production capacity, and reducing costs.
  • Developed new exam gloves product Led projects for continuous process/product quality improvement and cost reduction for K-C Safeskin operation in Thailand.

10. Process Characterization

Here's how process development scientists use process characterization:
  • Authored and executed Product and Process Characterization Protocols in Formulation for new and old products process transfers or process enhance.
  • Developed strategies for process characterization studies and validation work.

11. IND

IND which stands for "Investigational New Drug" are drug applications submitted to the Food and Drug Administration (FDA). Some IND is submitted to start clinical trials to gain marketing approval for commercial purposes while others are purely research-oriented to study an unapproved drug for a patient population or new evidence.

Here's how process development scientists use ind:
  • Prepare IND sections for filing.
  • Supported efforts for IND filing.

12. DOE

DOE, DOX, or design of experiments is a term used to refer to a part of applied statistics whose main focus is to conduct and observe controlled tests with the ultimate goal of understanding and explaining how information and results might vary under different hypotheses and circumstances and how such variables affect the results and tests. Design of experiments is used in marketing, politics, various sciences, and, of course, experiments.

Here's how process development scientists use doe:
  • Executed DOE experiments and analyzed data.
  • Create and develop Standard Operation Procedure (SOP) of processes based on DoE, FMEA.

13. Manufacturing Support

Here's how process development scientists use manufacturing support:
  • Managed product transfers and provided manufacturing support.
  • Provided quality and manufacturing support.

14. Drug Substance

Here's how process development scientists use drug substance:
  • Created Material Impact Assessments (MIA) for raw materials and consumables used for the manufacturing of drug substance.
  • Performed LC-MS/MS analysis for the identification and structure elucidation of drug substance degradation products and impurities.

15. HPLC

Here's how process development scientists use hplc:
  • Process development, Synthesis, UFDF and HPLC equipment scale up and process validation.
  • Performed media optimization, SDS-PAGE, ELISA & HPLC and SOP generation.
top-skills

What skills help Process Development Scientists find jobs?

Tell us what job you are looking for, we’ll show you what skills employers want.

What skills stand out on process development scientist resumes?

Rev. Grace Song

Won Buddhist Studies Department Chair, Won Institute

-High degree of emotional intelligence
-Ability to facilitate discussion and various meditation exercises
-Experience teaching online and offline
-High level of cultural humility

What soft skills should all process development scientists possess?

Rev. Grace Song

Won Buddhist Studies Department Chair, Won Institute

-Clear communicator
-Good time management skills
-Ability to resolve conflicts
-Self-aware
-Values collaboration

What hard/technical skills are most important for process development scientists?

Rev. Grace Song

Won Buddhist Studies Department Chair, Won Institute

-Comfortable using tech (eg. zoom)
-Certificated mindfulness instructor
-Experience running retreats/workshops

What process development scientist skills would you recommend for someone trying to advance their career?

Scott Johnson

Professor and Director, University of Maine

This would depend on the student's goals. If interested in working in the environmental industry: HAZWOPER training, obtaining a Professional Geologist certification, developing programming skills. The PG can be obtained through self-study to pass the exam; then, the experience is needed to receive official accreditation. HAZWOPER training can be obtained through short courses. Programming skills in many popular languages can be learned online and with freely available material on the internet. I'd also advocate for people getting work experience, if possible. On a general note, computer programming skills, math/physics knowledge, GIS/remote sensing, and UAV training are valuable ways to use a gap year. Students can do these things effectively from anywhere, as long as they have a computer. There are many online options and even apps to improve knowledge in these fields and are needed for what we do.

What type of skills will young process development scientists need?

Joe HarrisonJoe Harrison LinkedIn profile

Animal Scientist and Extension Specialist, Washington State University

Critical thinking and the ability to make the best decisions, realizing that they will make better decisions as one gets more experience. A second skill is the ability to navigate conflict in the workplace.

What technical skills for a process development scientist stand out to employers?

Dr. Joey Neilsen

Assistant Professor, Villanova University

I think programming skills and data analysis/statistics are especially valuable right now, while data science is so big. Our students take a year of Computational Physics in Python, and we integrate Python into some of our upper-level courses and labs as well. Our recent graduates, both in academia and the private sector, report using those skills on a regular basis. Two other skills that US Physics graduates report using regularly are technical problem solving and technical writing. This makes lots of sense from an employer perspective: you want to hire people who can identify and solve problems and then clearly explain the solution to your team. This is a great reason to let those lab reports shine!
Do you want to know more?
Read more about what experts have to say about process development scientist

List of process development scientist skills to add to your resume

Process development scientist skills

The most important skills for a process development scientist resume and required skills for a process development scientist to have include:

  • GMP
  • Data Analysis
  • Technical Reports
  • Harvest
  • CMC
  • Statistical Analysis
  • Tech Transfer
  • Analytical Methods
  • Product Quality
  • Process Characterization
  • IND
  • DOE
  • Manufacturing Support
  • Drug Substance
  • HPLC
  • Dosage Forms
  • FDA
  • Product Development
  • Development Reports
  • Experimental Data
  • Technical Support
  • Clinical Trials
  • QC
  • Formulation Development
  • Centrifugation
  • Elisa
  • Liquid Chromatography
  • CMO
  • Cell-Based Assays
  • GLP
  • Visualization
  • Media Development
  • Test Methods
  • Pilot Scale
  • PCR
  • Process Validation
  • Cell Lines
  • Electrophoresis
  • SDS-PAGE
  • SME
  • QbD
  • Assay Development
  • TFF
  • Process Optimization
  • Pilot Plant
  • Production Process

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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