Responsible for leading the Contract Research Services laboratory projects for various client-driven research projects in accordance with cGLPs/cGMPs and FDA regulatory guidelines, where applicable. Coordinates with the Laboratory Director regarding project plans and completion. Assists in day-to-day supervision of the Contract Research Servies laboratory as well as training of staff in various techniques employed for projects.
Essential R&D Laboratory duties and responsibilities include the following. Other duties may be assigned.
- Assist Laboratory Director in development and execution of project plans, including managing project timelines and goals. Projects will cover a wide array of disciplines, with a focus in molecular techniques including nucleic acid, immunoassay, and cell based assays.
- Accurately and efficiently design and perform laboratory experiments for development of methodologies and/or instrumentation that may be used for compliant 510(k) submissions, record and analyze data, and present data to Laboratory Management.
- Develop clear and concise written reports on various research projects for presentation to Laboratory Management
- Must have Next Generation Sequencing Experience. Familiarity with Illumina sequencing instruments is preferred.
- Project management experience is preferred.
- Assist in development of Standard Operating Procedures for processes and equipment associated with research projects.
- Assist in day-to-day supervision of the R&D Laboratory, including training of employees, where required.
- Troubleshoot procedural or technical issues associated with laboratory experiments performed by self and other team members. Perform and ensure appropriate corrective actions are taken, if required.
- Adhere to the laboratory’s general policies and procedures, including those associated with the laboratory’s Quality Assurance and Safety Programs.
- Display a high degree of dependability, versatility, judgement, and skill in carrying out assigned tasks.
- Maintain a safe, orderly working area.
- Work with little to no supervision.
- No direct reports.
Direct Supervisor: Laboratory Director
Education, Experience and Qualifications Required
- BA/BS, MS, or PhD in chemical, physical, or biological sciences, medical technology, or clinical laboratory sciences.
- BA/BS - at least 10 years general laboratory experience.
- MS – at least 5 years general laboratory experience.
- PhD – at least 2 years general laboratory experience.
- Experience in design and creation of bacterial and mammalian expression systems.
- Experience in standard molecular biology techniques, including nucleic acid extraction, PCR & primer design, cloning for recombinant expression (genomic & plasmid based, restriction enzymes, CRISPR/Cas9), sequencing (PCR based and whole genome), and sequence alignment analysis. Experience in next-generation sequencing and SNP analysis is an advantage.
- Familiar with mammalian cell culture techniques, media requirements/preparation, microscopy, and cell-based molecular methods such as flow cytometry, FISH, etc.
- Experience in design and performance of immunoassays, ELISA, and protein purification as well as peptide sequence alignments and proteomics analysis.
- Ability to communicate the progress of projects clearly and concisely via presentations and/or regular written reports.
- Familiarity with cGLPs/cGMPs and FDA guidelines for the clinical, pharmaceutical, and biological industries is an advantage.
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solving.
- Demonstrates initiative and proactively provides collaborative support to other team members.
- Ability to maintain accurate and reliable record keeping.
- Ability to plan and organize work in an efficient manner and work well under time constraints.
- Ability to exercise creativity and judgment.
- Excellent oral and written communication skills.
- Major Medical Insurance, company sponsored
- Dental Insurance
- Vision Insurance
- 401k option, company matches up to 3%
- Optional Voluntary Insurances
- 8 holidays and 1 Floating Holiday per year