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Senior formulation scientist skills for your resume and career

Updated January 8, 2025
7 min read
Quoted expert
David Cool Ph.D.
Below we've compiled a list of the most critical senior formulation scientist skills. We ranked the top skills for senior formulation scientists based on the percentage of resumes they appeared on. For example, 14.7% of senior formulation scientist resumes contained dosage forms as a skill. Continue reading to find out what skills a senior formulation scientist needs to be successful in the workplace.

15 senior formulation scientist skills for your resume and career

1. Dosage Forms

Here's how senior formulation scientists use dosage forms:
  • Designed and executed formulation experiments for multiple projects encompassing immediate and controlled release solid oral dosage forms.
  • Managed and developed new generic formulations and process for solid dosage forms for immediate/sustained release tablets.

2. Scale-Up

Scale-Up refers to the act of making a product or model larger. Because all dimensions of the product must be increased, the scale of the model or rendering is increased as well. It may also refer to the act of increasing attention or force behind a certain idea or action, such as a scaled-up attempt to combat murder hornet infestations.

Here's how senior formulation scientists use scale-up:
  • Provided scale-up and tech transfer support to commercial manufacturing facilities through process validation and subsequent manufacturing activities.
  • Authored technical transfer documents, scale-up batch reports, and CMC sections supporting ANDA submission.

3. Formulation Development

Formulation Development of a product requires knowledge of patentability, lifecycle, and stability of the product, which leads to its ultimate success. In the pharmaceutical and biotechnology industries, formulation development is an important skill to possess as it is an integral part of pharmaceutical product development. For example, in large pharmaceutical companies, formulation chemists are hired to deal with the physical drugs' characterization, conduct long-term drug stability, develop prototypes for testing, and more. All of these complicated tasks require you to have extensive knowledge in the formulation development of medical products.

Here's how senior formulation scientists use formulation development:
  • Researched new technology for formulation development of highly insoluble compounds including processing methodology and formulations.
  • Designed and executed formulation development, process development, process optimization, and stability protocols.

4. 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 senior formulation scientists use gmp:
  • Manufacture of GMP clinical supply batches and data evaluation.
  • Coordinated IQ/OQ and GMP validation of new equipment.

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 senior formulation scientists use cmc:
  • Scaled up and developed process techniques and edited CMC for ANDA submission.
  • Prepared regulatory submission package (CMC section) including reference standard, drug substance characterization and impurity characterization.

6. Data Analysis

Here's how senior formulation scientists use data analysis:
  • Conduct excipient compatibility studies, experimental design, study execution, data analysis and reports to support NDA filings.
  • Challenged with increasing product performance through material advancements, data analysis, and manufacturing process optimization for grid scale battery manufacturer.

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7. QbD

Here's how senior formulation scientists use qbd:
  • Prepared Quality Overall Summary, QbD reports for ANDA filing.
  • Performed QbD Batches to understand critical material quality attributes and critical process parameters.

8. 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 senior formulation scientists use ind:
  • Designed and executed formulation and characterization studies for small molecule candidates to drive rapid decision making and support IND filing.
  • Study directed pivotal toxicology studies, co-authored the nonclinical safety assessment, and reviewed and edited IND documents.

9. ICH

Here's how senior formulation scientists use ich:
  • Recommended novel packaging for Spray Dried Dispersion (SDD) stability-limited tablets based on preliminary ICH stability data.
  • Design and execute the ICH stability programs for drug substances and drug products.

10. DSC

DSC - Differential Scanning Calorimetry is a thermo-analytical technique used to measure how much energy a sample absorbs or releases while heating or cooling. Thus, DSC measures the amount of heat required to increase the temperature of a sample as a function of temperature or time.

Here's how senior formulation scientists use dsc:
  • Applied microcalorimetry (DSC) to characterize protein-protein/ligand interaction and to study protein stability under different formulation conditions.
  • Well versed in operation of lyophilizers as well as in analytical instrumentation such as ITC, DSC, and Freeze-Dry Microscope.

11. Drug Products

A drug product is a drug that has the finished dosage form which is the final product from a pharmaceutical company bearing an active ingredient. The active ingredient is tagged along with other inactive ingredients that make the product whole in the effect that it offer to users.

Here's how senior formulation scientists use drug products:
  • Lead drug product temperature excursion program to ensure supply continuity and patient safety.
  • Performed Spectroscopic study, Freeze thaw study, Bulk Product hold time study and compatibility study of drug product.

12. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how senior formulation scientists use fda:
  • Participated in preparing documentation for FDA.
  • Reviewed intellectual property patents and developed non-infringing formulations, with paragraph IV filings accepted by the FDA.

13. 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 senior formulation scientists use technical reports:
  • Author and review technical reports and SMC documents for ANDA submissions and regulatory agency comment letters.
  • Supervised Junior level scientists and interns Prepared high quality technical reports, presentations, patents and product development reports.

14. GLP

GLP stands for "good laboratory practice." This refers to the integrity and quality measures that non-clinical laboratories have in place to ensure accurate research and market testing. GLP is most often used in pharmaceutical companies where new drugs must be tested before being approved for sale, but the practice can also be used in food packaging and preparation test centers.

Here's how senior formulation scientists use glp:
  • Developed nasal formulations and prepared several batches under GLP and cGMP for preclinical and clinical studies.
  • Scheduled and supervised the conduct of GLP and exploratory toxicology studies to ensure compliance with all regulatory guidelines.

15. NDA

A non-disclosure agreement, also called a confidentiality agreement, refers to the constitutional paperwork that compels two parties to keep each other's data fully confidential. Trade secrets and different types of sensitive data are kept secure via an NDA. If one party doesn't keep up his end of the bargain, they will break the law and may face charges.

Here's how senior formulation scientists use nda:
  • Supported testing of NDA registration batches and method transfer activities to commercial sites.
  • Authored the nonclinical ADME section for an NDA filing.
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What type of skills will young senior formulation scientists need?

David Cool Ph.D.David Cool Ph.D. LinkedIn profile

Professor, Pharmacology & Toxicology; Professor, Obstetrics & Gynecology, Wright State University

The skill sets that young graduates will need when they graduate and enter the workforce are similar to and vastly different from just 15-30 years ago. If they are working in a laboratory setting, then the standards are the same; accurate pipetting, the ability to make complex buffers, and understanding how all the necessary equipment in a lab works. However, that is not nearly enough nowadays. The equipment and instrumentation have been expanding exponentially to the point that you will be working with both expensive and complicated instruments to generate a more considerable amount of data than anyone ever thought possible. Standards for labs today will be using digital imaging devices to capture everything from microscopic images, to western blots, to automated living cell analysis using multi-well plates. Multiplexed assays for 27 to 50 to 1050 cytokines and proteins have replaced single marker ELISA. But knowing ELISA will allow you to be trained to do the multiplexed assays. Most pharmaceutical companies have a great need still for 'old-fashioned' HPLC techniques. Every student I have had in my research techniques class, that graduates and goes for a Pharma position, comes back and tells me they asked them if they could run an HPLC.
Some were even given a test to see if they understood the concept. This then leads to mass spectrometry, LCMS, MALDI-TOF, and even GCMS, and everything that has been developed around those basic techniques is now commonplace in most core facilities and Pharma. New methods for flow cytometry, FACS, are necessary for the higher throughput drug discovery types of labs. Molecular biology has evolved from simple PCR machines that could run 24 samples, just 25 years ago, to digital PCR machines that can run 384 pieces today and email the final data to you at home, while you sleep. Knowing how to calculate the PCR data is extremely critical, as it isn't intuitive, and people tend to take short cuts. Knowing how to do that will be vital. Cell culture and working with animals are still common ways to generate data in any lab, and people who have those skills will always have a job. What do all these techniques have in common? They all have evolved to the point that no one is an expert in every one of them. Labs focus and concentrate on the ones they need the most and make use of them over a long period. What a student should develop is what I call a big toolbox. Learn as many of these techniques as you can, and then use them. Understanding that these are all cyclic and that you may get rusty, or the technology will change. It doesn't matter. By being trained in any of these, it will mean that you can be prepared for other things, that you can catch up and learn and update your techniques in your toolbox. This is what any PI running a lab will be looking for, someone who can be trained, and can evolve and adapt to different technologies, know how they work and how they can be used, what the data looks like when it is working well, and what it looks like when it isn't. The people who have these skills will always be employable.

There is a greater need than ever for workers to analyze data and synthesize a reasonable idea about what it means. This means that they must understand their experiments at a deeper level than just pipetting buffers and timing reactions. They must know what is happening, and if there is a problem, first, they have a problem and then how to solve it. Bioinformatics has become one of the fastest-growing fields. The increased amount of data, whether from standard assays run in an ordinary lab or high throughput data, needs more crunching. The future researcher will not be able to get by just knowing how to use a computer stats program but will be required to understand how to run data in R or Python or whatever new data analysis package is coming next. This becomes even more critical as the data becomes more complex, i.e., 27 cytokines analyzed in 3 different tissues over three other times, from 14 different groups, 6 of which are controls, with the rest being toxin and then treatment groups and authorities. A simple two way ANOVA just doesn't cut it. For this, machine learning tools, pattern recognition, neural networks, topological data analysis (TDA), Deep Learning, etc., are becoming the norm and are being advanced and changed to give more and more substance to what the data means. Students who can operate instruments to generate data and run more complex types of analysis on this 'big data' are in great demand. Likewise, learning the computer-generated design of drugs 'in silico' is a growing field that is now required to screen tens of thousands of compounds before generating them in the lab. This will need someone who can think three-dimensionally; even though the software and advanced computers can do that, it helps if your brain is wired that way, at least a little.

Aside from instruments and complex data analysis, consider where the clinical research is headed. With COVID19, the need to quickly advance drugs from potential use to clinical application has undergone an exponential increase. Lives are being lost daily to the lack of a vaccine or medication that can attenuate to any level the impact the virus has on the human body. The future clinical researcher will need to understand how the instruments work and how tests are run, how a vaccine works, how the virus or disease manifests itself, and how to get it under control. This will only be possible if the researcher is familiar with much of what I wrote above. You won't need to be an expert on virtually everything, but you'll need to understand it so you can use it to synthesize new ideas that may be applicable in the clinical environment. COVID19 is a perfect example. One of the early struggles with this virus was how to test for it. Antibodies weren't developed for it in the very beginning, so an ELISA was out.

In contrast, PCR is one of the most sensitive methods to identify genetic material, such as viruses. So, early on, PCR primers were created that could be used to run a PCR to determine if a person had a live virus. However, the first such PCRs had high false negatives and positives. Further refinement led to the creation of PCR primer sets and protocols that allowed for a more accurate and faster test. An advantage that anyone who has been trained in biotechnology will know the basics of developing a test. If it is a PCR, then what goes into that. Suppose it is an ELISA, how it works, and what you need to set it up. Imagine a test strip similar to the one used for at-home pregnancy tests. This came about in much the same way, through experimentation and developing a way to lower the false negatives and positives, to allow a quick, 5-minute test that could determine if a particular hormone was in your urine at a stage of pregnancy when many women may not have realized there was a possibility they could be pregnant. The person entering the workforce that can think in these ways will be employable and will be able to move between jobs and continue with a very successful and enriching career.

List of senior formulation scientist skills to add to your resume

Senior formulation scientist skills

The most important skills for a senior formulation scientist resume and required skills for a senior formulation scientist to have include:

  • Dosage Forms
  • Scale-Up
  • Formulation Development
  • GMP
  • CMC
  • Data Analysis
  • QbD
  • IND
  • ICH
  • DSC
  • Drug Products
  • FDA
  • Technical Reports
  • GLP
  • NDA
  • Clinical Trials
  • JMP
  • R
  • CMO
  • Analytical Methods
  • HPLC
  • Stability Studies
  • Experimental Design
  • IP
  • Clinical Studies
  • Process Validation
  • DOE
  • Analytical Data
  • Formulation Studies
  • GC
  • Preformulation
  • QC
  • Fluid Bed
  • Research Projects
  • Cleaning Validation
  • Nanoparticles
  • Extrusion
  • Drug Substance
  • API
  • Absorption
  • Study Protocols
  • Product Development

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.

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