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Associate principal scientist skills for your resume and career
15 associate principal scientist skills for your resume and career
1. Data Analysis
- Process oversight includes maintaining cell lines, preparing protocols, compound preparation, data analysis, report creation and laboratory maintenance.
- Collaborated with disease area biologists on experimental design and performed data analysis for mass spectrometry-based target ID and validation experiments.
2. Chemistry
Chemistry is the branch of science that tells us about the composition, properties, and structure of elements and compounds. The processes these elements undergo and how they undergo change all come under the branch of chemistry.
- Implemented innovative scientific solutions in collaboration with medicinal chemistry partners.
- Managed multiple chemistry projects in dynamic discovery space.
3. Project Management
- General project management and representation on mid-level Product Development team/s for high-profile oral combination drug products.
- Created database applications for sample tracking and project management.
4. Clinical Trials
- Design mechanistic studies to evaluate immune modulation and therapeutic response in phase 1, 2 and 3 clinical trials.
- Managed a portfolio of antioxidant; responsible for selecting raw materials for advancement to clinical trials.
5. 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.
- Phase II: The optimized procedure from kilo lab was transferred to pilot plant under GMP guidelines.
- Implement Potency / Analytical Method development with successful transfer to appointed GMP facility.
6. Sops
A standard operating procedure or simply SOP is a particular operation that needs to be done in accordance with the rules and guidelines of a company or an industry. It is an important way for a company to run smoothly, especially in small businesses. It is like a practice wherein everything an individual or an employee is under a particular standard that is implemented.
- Write SOPs, project proposals and study reports, supervise research associates and junior scientists in performing experiments and career development.
- Involved in Quality System Program under consent decree to revise and implement SOPs.
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- Compound advanced to clinical development.
- Supported early clinical development by assessing in vitro combinations, biomarker identification and generating samples for clinical IHC assay development.
8. 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.
- Compiled several batch records, technical reports, and campaign summary reports.
- Prepared technical reports and SOP.
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.
- Led comparability studies and drafted CMC sections for regulatory submissions.
- Authored several regulatory submissions (IND/IMPD, NDA/MAA), leading to successful regulatory approval.
10. Clinical Studies
- Developed the final step in the synthesis of a new drug candidate to prepare material for toxicology and clinical studies.
- Planned and executed GLP quality API on compressed timelines to support preclinical studies.
11. Regulatory Agencies
A regulatory agency is a Public Benefit Corporation (PBC) that is responsible for supervising certain human activities and controlling them to some extent. They are set up in some areas such as hospitals, law firms, and governmental setup to regulate safety standards. They prevent undue and unjust abuse of power in these setups.
- Prepare reports and documents for submission to regulatory agencies.
12. Experimental Design
Experimental design is the process of researching in an objective and controlled manner to maximize precision and draw specific conclusions about a hypothesis statement. It is a concept used to efficiently organize, conduct, and interpret the results of experiments to ensure that as much useful information as possible is obtained by conducting a small number of trials. This minimizes the effects of the variables to increase the reliability of the results.
- Applied experimental design techniques to maximize power of mammalian longitudinal studies by validly reducing dimension up to 22%.
- Mentored colleagues in general laboratory techniques including experimental design and interpretation, aseptic technique, cell culture, and western blotting.
13. 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.
- Coordinate results, writing analytical methods and specifications, validation and toxicology reports for regulatory filling submission.
- Developed and validate analytical methods for various drug substance/drug product release and stability, following GLP/GMP practices.
14. 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.
- Process Development: Authored testing protocols, clinical batch records and related development/regulatory documents (IND and NDA).
- Perform raw material and final product release of exhibit batches for ANDA and NDA submissions.
15. Cros
- Collaborated with CROs for delivery of intermediates.
- Led the design and execution of numerous outsourced projects in collaboration with CROs and Academic collaborations.
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List of associate principal scientist skills to add to your resume
The most important skills for an associate principal scientist resume and required skills for an associate principal scientist to have include:
- Data Analysis
- Chemistry
- Project Management
- Clinical Trials
- GMP
- Sops
- Clinical Development
- Technical Reports
- Regulatory Submissions
- Clinical Studies
- Regulatory Agencies
- Experimental Design
- Analytical Methods
- NDA
- Cros
- Cell-Based Assays
- IND
- BLA
- Drug Products
- Pharmacokinetics
- Method Development
- Product Development
- Assay Development
- HPLC
- Drug Substance
- Biomarkers
- Direct Reports
- FDA
- Study Design
- CMC
- API
- GLP
- Dosage Forms
- DOE
- Early Development
- QC
- QbD
- Elisa
- Pharmacodynamics
- Technical Support
- Drug Metabolism
- UPLC
- R
- Drug Candidates
- PK/PD
- SAR
- ICH
Updated January 8, 2025