Senior Scientist, Assay Development & Tech Transfer:
This individual designs and executes experiments to analyze and characterize proteins. The individual will have the experience to develop client specific analytical protocols which are reproducible and can be transferred to GMP QC for qualification.
- Has awareness of new methodologies pertinent to their function and is able to introduce them.
- Expertise in such analytical techniques as HPLC, GC, CE, gel electrophoresis, bioactivity assays, spectroscopic measurements (UV-Vis, IR, fluorescence, turbidimetry), thermal analysis (DSC, thermal fluorescence and microcalorimetry), DLS;
- Can collaborate independently with other Paragon departments and clients on protein characterization, tech transfer and act as interface between product development and GMP.
- Takes responsibility for installing/maintenance/operation of lab and relevant equipment.
- Responsible for time management with regard to experimental studies.
- Has an awareness of all aspects of a project including upstream development, downstream development and across all functional areas.
- Investigates and troubleshoots all technical problems related to assigned projects.
- Is aware of the statistical design of experiments and is able to present statistically justified results.
- Provides detailed reports and presentations to the client.
- Provides strategic support for how proteins are characterized.
- Is open to cross training to understand and perform analytical testing using a wide variety of analytical assays and analytical instruments.
- Understands upstream production of protein in mammalian and bacterial cultures.
- Understands downstream production of purified proteins including, filtration, concentration techniques, column and batch binding protein purification.
- Understands molecular biology techniques such as cloning, vector selection, RT-PCR, PCR and expression analysis.
- Is familiar with host bacterial growth, phage growth and purification and related characterization assays.
- Is familiar with GMP reagents and common GMP test methods and is able to identify qualified vendors for outsourced analytical methods.
- Is familiar with GMP required documentation and qualification of methods.
- Implement knowledge/technical skills to execute studies in a timely manner and present results in regular updates to clients/groups. This should involve a complement of technical skills. Examples may include:
- Purification of analytical scale specific molecule.
- Interacting with appropriate upstream and Analytical functional areas.
- Development and execution of purification and analytical protocols.
Planning and Decision Making
- Develops strategy for characterization of protein, including assay development, transfer of assay to GMP if necessary and participates in client meetings and long-term project goals.
- Initiate and develop plans to ensure the timely completion of several sets of experiments.
Scientific & Technical Leadership
- Effectively communicates results of own work through scientific meetings, presentations, discussions and documentation.
- Develops new technology as needed.
- Provides leadership for instrumented protein separation analysis, specifically CE, HPLC and GC.
- Attends conferences, seminars and/or training sessions on a regular (annual) basis, or as necessary, to further scientific expertise or to explore new topics related to project or lab responsibilities.
- Provides supervisor with detailed progress and final reports for projects under their responsibility.
- Participates in client meetings to help strategize analytical needs for development projects and for transfer to GMP.
- Will train others on new instruments or how to run assays.
Education and Previous Experience
- M.S. or B.S. in Chemistry, Biology, Life Sciences or related field, with 10-20 years of experience in pharmaceutical or biotechnology industry or academia.
- The ability to work in a team oriented environment and interact across functional groups is essential.
Primary candidates ONLY. No recruiting agencies.
Interested parties are encouraged to mail their CV with a cover letter to:
Paragon Bioservices, Inc.
Attn: Human Resources
801 W Baltimore St
Baltimore, MD 21201