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Process development associate skills for your resume and career
15 process development associate 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.
- Collected offline/online data and adjusted parameters according to experimental protocols in compliance with GMP.
- Transferred above process into the clean room environment under GMP: * Helping in creating Batch Records.
2. Data Analysis
- Prepared data analysis and reports, R&D briefings, and safety documentation.
- Execute data analysis and present data to the team and company.
3. Statistical Analysis
- Optimized purification process using DOE and statistical analysis with collaboration of project lead.
- Analyzed process data using statistical analysis tools.
4. 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.
- Supported technology-transfer for analytical methods and manufacturing operations for new developed products.
- Executed analytical methods following client specific SOPs.
5. Troubleshoot
Troubleshooting is the process of analyzing and fixing any kind of problem in a system or a machine. Troubleshooting is the detailed yet quick search in the system for the main source of an issue and solving it.
- Clean, prep media, sterilize, assemble, inoculate, troubleshoot, harvest, terminate all tanks.
- Operated feasibility and prototype manufacturing equipment to provide performance feedback and troubleshoot failures.
6. HPLC
- Performed HPLC purification of individual bone growth factors including TGF- 1 and TGF- 2.
- Developed HPLC based assays to show clearance of purification additives from process buffer pools.
7. JMP
- Evaluate results and interpret data by statistical analysis (JMP) to modify process parameters.
- Use JMP statistical software to analyze data from range finding research.
8. Bioreactors
- Support efforts to define preliminary fermentation process conditions and control strategy for Seed Stage Bioreactors.
- Harvested bioreactors for further analysis.
9. 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.
- Designed protocols, executed experiments, and analyzed data to write technical reports.
- Drafted, reviewed and revised the associated technical report(s) for the submission of a supplemental BLA.
10. Process Characterization
- Assist in optimization, process characterization, formulation, filling and finish processes for protein products in liquid and lyophilized forms.
- Authored and executed Product and Process Characterization Protocols in Formulation for new and old products process transfers or process enhance.
11. Harvest
- Implemented scaled up product recovery, cutting harvest time in half.
- Evaluated growth and harvest conditions for mammalian cells on various microcarrier types (Asahi, Cytodex, Cultisphere).
12. Experimental Data
Experimental Data is science and engineering data produced by measurements, test methods, and experimental designs. Data is collected and measured through standard objectives.
- Compiled production/experimental data for weekly departmental meetings and periodically gave interdepartmental presentations.
- Presented in bimonthly Sprint reviews to company executives and departmental managers with experimental data and project updates.
13. Equipment Maintenance
Equipment maintenance is any process that includes the use of maintenance methods and procedures to keep the organization's equipment in good and reliable working condition. This may include routine maintenance as well as corrective repairs. The practice takes place in a variety of settings, including catering establishments, industrial factories, manufacturing facilities, hotels, etc.
- Maintained chemical and lab supplies inventory and performed routine equipment maintenance.
- Trained production operators on the process flow, processes, safety and equipment maintenance.
14. Analytical Techniques
Analytical technique is a method or procedure for the analysis of some problem or a fact. It is used for the quantitative and qualitative determination of a problem using various technique.
- Developed and validated new analytical techniques for the analysis of finished goods.
15. Bench Scale
- Developed reproducible bench scale processes.
- Performed purification at bench scale of 5mL - 15L and pilot scale runs of 50L-200L.
What skills help Process Development Associates 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 associate resumes?
Daniel Lindstrom Ph.D.
Associate Professor of Biology, University of Guam
What soft skills should all process development associates possess?
Kristen Johnson Ph.D.
Assistant Professor of Biotechnology, University of New Hampshire- Manchester
What hard/technical skills are most important for process development associates?
Kristen Johnson Ph.D.
Assistant Professor of Biotechnology, University of New Hampshire- Manchester
What process development associate skills would you recommend for someone trying to advance their career?
What do I mean by "entrepreneurial mindset"? It begins with curiosity. Am I curious about new things on the horizon? Are they opportunities or threats to me? In either case, do I consider possible ways to deal with it? Or do I just carry on without further thought? Beyond heightened awareness, do I have a bias toward action? Am I willing to take reasoned risks? If I try something and it doesn't work out, do I consider it a failure or a learning experience? These are some of the basic dimensions of entrepreneurial mindset. For more insight, there is plenty of searchable material on the subject.
A very useful way to utilize a gap year is to enhance your personal development by assessing your skill set with respect to:
-Succinct writing
-Oral presentation
-Negotiation
-Personal finance
-Leadership and team participation
-Personal branding
These skills are important to entrepreneurs, but more importantly, they are valuable to everyone regardless of career path and are highly prized by employers. The number one skill valued by employers beyond specific job-related skills, like mechanical engineering, is the ability to present well. For each of these skill areas there is a wealth of free or inexpensive materials, workshops, and resources to help you hone your skills. Most graduates have had little or no training.
Dependent on financial circumstances, a gap year could be used to find ways to broaden your experience portfolio. Volunteer in a social enterprise or non-profit, intern in an area of interest, or try to participate in an entrepreneurial startup. Also, there are many quality online courses becoming available which you could take to broaden your value.
What type of skills will young process development associates need?
Associate Professor, Biology Department Co-Coordinator, Undergraduate Biotechnology Program, Worcester State University
The second category, the interpersonal "professional" skills, are just as (or, arguably, more) important than the technical skills. Communication is at the forefront of these skills - being able to collaborate clearly and effectively with others, to problem solve individually and as part of a team, and to engage in purposeful and respectful interpersonal interactions. A person can have all of the technical skills needed but may struggle in the role if they cannot effectively communicate and interact with their colleagues.
The working environment, by its very nature, requires communication and collaboration for success. These communication skills can include things like writing an appropriate email, using active listening and having meaningful dialogues with colleagues, and receiving and processing constructive criticism. Problem solving and creativity are also skills that fall into this category - you have to have the initiative to seek the answers and address issues; at the same time, you also need to recognize when to ask for help and seek that assistance. Lastly, time management, being flexible to situations, and a willingness to work hard are the bedrock of the skills that will be expected for a professional in biotechnology (or any field, for that matter). A 2019 article in Scientific American by Karla Talanian from the Massachusetts Biotechnology Foundation (MassBioEd) highlights more of the "soft skills" that biotechnology companies and laboratories are looking for in their new hires and employees.
List of process development associate skills to add to your resume
The most important skills for a process development associate resume and required skills for a process development associate to have include:
- GMP
- Data Analysis
- Statistical Analysis
- Analytical Methods
- Troubleshoot
- HPLC
- JMP
- Bioreactors
- Technical Reports
- Process Characterization
- Harvest
- Experimental Data
- Equipment Maintenance
- Analytical Techniques
- Bench Scale
- Product Quality
- Pilot Plant
- Elisa
- Laboratory Equipment
- Method Development
- Process Optimization
- Liquid Chromatography
- Pilot Scale
- Clinical Trials
- GLP
- QC
- Cell Lines
- Lims
- Centrifugation
- Electrophoresis
- Process Validation
- RNA
- Cell Culture
- FDA
- R
- Experimental Design
- Data Entry
- Process Improvement
- Technical Support
- QA
- ICH
- DOE
- ELN
- PCR
- SDS-PAGE
- Cell-Based Assays
Updated January 8, 2025