SENIOR DEVELOPMENT SCIENTIST SKILLS, EXPERIENCE, AND JOB REQUIREMENTS
Published: Oct 24, 2024 – The Senior Development Scientist has experience in automated chromatographic and filtration equipment, with a background in downstream purification development for large-scale clinical GMP manufacturing. This role demands strong technical writing and presentation skills, along with proficiency in JMP and other statistical analysis tools in life sciences. The senior demonstrates leadership experience in process validation and large-scale manufacturing operations within a GMP environment.
Essential Hard and Soft Skills for a Standout Senior Development Scientist Resume
- Experimental Design
- Data Analysis
- Statistical Software Proficiency
- Molecular Biology Techniques
- Regulatory Compliance
- Product Development
- Quality Control
- Technical Writing
- Project Management
- Bioinformatics
- Critical Thinking
- Problem-Solving
- Communication
- Team Collaboration
- Adaptability
- Attention to Detail
- Time Management
- Creativity
- Leadership
- Interpersonal Skills
Summary of Senior Development Scientist Knowledge and Qualifications on Resume
1. BS in Molecular Biology with 5 years of Experience
- Experience in protein-based assay development
- Expert-level knowledge of protein biochemistry, specific optimizations for antibody-based methods (e.g. ELISAs, Western blots), and common analytical platforms (e.g. Luminex, MSD)
- Demonstrate a track record of establishing new methods that go beyond kitted assays
- Ability to design for automated platforms in plate-based, low-volume formats, and/or microfluidics
- Experience working with automated liquid handlers
- Proficient in managing technology transfer requirements, including guard-banding, stability studies, and in-process quality control
- Experience working in a regulated laboratory environment (CLIA, GLP/GCLP, IVD development)
- Clear communication skills and ability to work with team members in the same and adjacent disciplines
- Understanding of immunology, cancer biology, and/or the biology of human plasma
- Experience mentoring and training research associates and junior scientists
2. BS in Biotechnology with 8 years of Experience
- Experience in molecular diagnostic assay development, preferably in an FDA-regulated environment for IVD under design control.
- LDT/CLIA and CE-IVD experience
- Premarket Approval (PWA) submission experience
- Experience developing Multi-Analyte Assays with Algorithmic Analysis (MAAAs) and/or In Vitro Diagnostic Multivariate Index Assays (IVDMIA).
- Broad, expert-level knowledge of NGS assays for DNA and RNA, including general nucleic acid biochemistry as well as specific optimizations for different applications, sequencing platforms, and analytes.
- Proven track record of establishing new methods for NGS-based measurements of biology (-seq) that go beyond kitted assays.
- Ability to program in a scientific programming language (e.g., Python or R) and perform bioinformatics analyses to enable experimental iteration independent of external support.
- Clear communication skills, ability to work with team members in the same and adjacent disciplines, and experience mentoring and training research associates
- Ability to design for automated platforms in plate-based, low-volume formats, and/or microfluidics and experience working with automated liquid handlers.
- Hands-on proficiency in managing technology transfer requirements, including guard-banding, stability studies, drafting work instructions, and in-process quality control.
- Understanding of the biology of human cell-free nucleic acids, single-cell analysis methods, immunology, and/or cancer biology.
3. BS in Biochemistry with 6 years of Experience
- Experience with automated chromatographic and filtration equipment.
- Experience with Background in downstream purification development and process characterization
- Large-scale clinical GMP manufacturing
- A good working knowledge of process characterization
- Management experience of a scientific staff
- Excellent technical writing and presentation skills
- Experience with JMP, and other statistical analysis tools in life science or engineering
- Demonstrate experience in protein purification and characterization of processes
- Evidence of supervisory, technical guidance, and leadership experience
- Experience with process validation activities and knowledge of large-scale manufacturing activities in a GMP environment
- Good writing, communication, and presentation skills.