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Scientist senior, research and development skills for your resume and career
15 scientist senior, research and development skills for your resume and career
1. Project Management
- Directed Project Management team accountable for portfolio of projects from idea-to- execution.
- Received extensive training on project management and design control.
2. 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.
- Synthesized, purified and characterized organic compounds under GMP requirements for Manufacturing.
- Performed and evaluated retest and long term stability studies for final GMP synthesized drug substance.
3. Product Development
Product development is the complete procedure of creating a product from concept until release of the final product. Product development has many stages after which a product is released into the market. Identifying the need, creating the opportunity, conceptualizing a product, and providing a solution, all are different stages of product development.
- Directed product development teams and provided technical expertise for development of products from prototype to finished product.
- Utilize high technical expertise and supervisory role to generate high performing team delivering on product development commitments.
4. HPLC
- Initiated and conducted stability study for drug substance and drug product using HPLC.
- Performed preventative and corrective maintenance on HPLC and LC/MS systems.
5. Method Development
- Authored and co-authored internal reports covering method development, and method validation.
- Supported product design/development and test method development for clinical trials/compliance.
6. 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.
- Conducted clinical trials for a diagnostic kit for cystic fibrosis disease carrier detection, which contributed to obtaining FDA 510K approval.
- Played an integral role in the successful 510(k) FDA submission for clearance of diagnostic AQUA analysis software.
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- Recommended novel packaging for Spray Dried Dispersion (SDD) stability-limited tablets based on preliminary ICH stability data.
- Authored ICH Common Technical Document (CTD) sections for inclusion in regulatory filings.
8. API
- Performed release testing of finished products (API, capsules, tablets).
- Developed specifications for API's and drug products and wrote spec justifications.
9. Regulatory Submissions
Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.
- Assist with clinical sections of regulatory submissions and international registration packages.
- Authored relevant sections of regulatory submissions as required.
10. 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.
- Developed, evaluated and validated stability indicative analytical methods for testing drug substances, in-process and intermediate compounds.
- Design and author protocols for and perform the validation of developed analytical methods against phase appropriate criteria.
11. Data Analysis
- Developed data analysis in SoftmaxGMP for team and modified as needed for assay development data.
- Advise on development efforts regarding data analysis methods with CLS capabilities in mind.
12. 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.
- Work daily with cross-functional department including QA, DSM, Regulatory CMC, Technical Operations, and others.
- Contributed to CMC teams' efforts and made oral presentations at project(s) meetings.
13. RNA
A Ribonucleic acid (RNA) has a vital role in determining the biological macromolecule commonly found in all bodily cells. It is the synthesis of protein, carriers message instruction from the Deoxyribonucleic acid or DNA. RNA is a kind of single-stranded cell that has different forms. It allows the molecule to go back and forth to its original condition.
- Developed Streck's patented Cell-Free RNA BCT blood collection device to preserve and stabilize circulating cell-free transcriptome in blood.
- Developed a binding experiment utilizing fluorescence polarization to screen discovery compounds for interaction with various RNA constructs.
14. Laboratory Equipment
- Drafted protocols and reviewed executed protocols for the qualification of all AR&D laboratory equipment.
- Assisted the site maintenance department in maintaining an active inventory of AR&D laboratory equipment.
15. 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.
- Study results were critically useful in formulation development, and targeted shelf life was met.
- Provided analytical support for formulation development of extended release and tamper resistant studies.
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What skills help Scientist Seniors, Research And Development find jobs?
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What skills stand out on scientist senior, research and development resumes?
Alexandra (Sasha) Ormond Ph.D.
Associate Professor of Chemistry, Director of Dual Degree Engineering, Meredith College
What hard/technical skills are most important for scientist senior, research and developments?
Alexandra (Sasha) Ormond Ph.D.
Associate Professor of Chemistry, Director of Dual Degree Engineering, Meredith College
What soft skills should all scientist senior, research and developments possess?
Alexandra (Sasha) Ormond Ph.D.
Associate Professor of Chemistry, Director of Dual Degree Engineering, Meredith College
What scientist senior, research and development skills would you recommend for someone trying to advance their career?
Scott Johnson
Professor and Director, University of Maine
What type of skills will young scientist senior, research and developments need?
What technical skills for a scientist senior, research and development stand out to employers?
Dr. Joey Neilsen
Assistant Professor, Villanova University
List of scientist senior, research and development skills to add to your resume
The most important skills for a scientist senior, research and development resume and required skills for a scientist senior, research and development to have include:
- Project Management
- GMP
- Product Development
- HPLC
- Method Development
- FDA
- ICH
- API
- Regulatory Submissions
- Analytical Methods
- Data Analysis
- CMC
- RNA
- Laboratory Equipment
- Formulation Development
- QC
- Research Projects
- Test Methods
- Drug Products
- Cell Culture
- Assay Development
- Technical Support
- Technical Reports
- Process Improvement
- QA
- GLP
- Molecular Biology
- PCR
- Elisa
- IND
- Dosage Forms
- Drug Substance
- Next-Generation Sequencing
- Immunoassay
- Medical Devices
- Analytical Development
- Liquid Chromatography
- Prototyping
- DNA
- Analytical R
- Method Validation
- ISO
- IP
- NDA
- Clinical Trials
- GC
- Ms
- Product Performance
Updated January 8, 2025