Analytical Development Sr. Scientist
Boca Raton, FL
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Analytical Development Sr. Scientist
- Location: Boca Raton, FL (position is on-site, not remote)
- Industry: Biologics
- Hours: M-F, 8am-5pm
- Employment Type: Direct hire
- Salary: Competitive compensation package plus bonus
Leading commercial biopharmaceutical company committed to manufacturing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection.
Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Works on complex problems in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Develop, qualify, validate Bioassays with minimum supervision, write SOPs and transfer methods to QC department as needed.
- Be familiar with regulatory guidelines pertaining to assay development/qualification/validation.
- Be familiar with BSL-2 laboratories and working in BSL-2 environment
- Design experiments and write protocols for assay development and validation.
- Perform assays or supervise other analysts for assay development and validation work.
- Frequently write technical reports and present findings to internal or external clients.
- Analyze experimental data with appropriate statistical tools and report scientific results.
- Interpret data and adhere to strict guidelines on documentation when recording data.
- Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary.
- Analyze samples from various sources to provide information on compounds or quantities of compounds present. Use of mammalian cell culture techniques
- Use analytical technique, software, and instrumentation, such as HPLC, GC, spectrophotometric assays, immunochemical methods, titration assays, SDS PAGE, IEF, ELISAs, enzymatic assays and/or IR spectroscopy
- Work collaboratively in cross-functional teams. Interact with contract labs in method development/qualification/validation.
- Liase with customers, staff and suppliers.
- Be aware of and keep up to date with health and safety issues in all aspects of the work undertaken.
- Use judgment, creativity and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
- Maintain an overview of current QC methods and propose areas for improvement.
- Maintain current knowledge in field of expertise through reading articles and attending technical courses.
- Minimum Bachelors Degree, Masters or PhD in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering is preferred
- This position requires at least five years of Biopharmaceutical/Biologics experience.
- Expert knowledge of scientific principles and concepts. Knowledge of working in a BSL-2 environment.
- As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner.
- Extensive experience with chemical/biochemical and biological testing is necessary. The individual should have experience with one or more of the following: mammalian cell culture techniques, Bioassay development, neutralization assays, method transfer, Bioassay development and validation. The individual should have experience in working under BSL-2 conditions and should be familiar with required guidelines and procedures. The individual should possess good communication skills, be detail-oriented, and able to work well with others. The individual should be flexible and able to handle multiple projects and task, able to solve problems with minimum help. Organizes and interprets all data obtained.
- Frequent contact with professional staff to exchange information, Quality Assurance, Process Development, QC Chemistry, Manufacturing, and Receiving Department personnel.
- Laboratory vendors/suppliers customer service departments and Contract Testing Laboratories.
- Working Conditions: Working under BSL-2 conditions, exposure to infectious materials (human source products), toxic chemicals, chemical fumes and odors, electrical hazards, temperature extremes when going to and from coolers and freezers. Must be willing to travel 25%