Biologics Process Development 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: Process Development Scientist II (Extractable and Leachable)
- 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
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. As a key member of the Process Development group provide support for Manufacturing, Quality Control/Quality Assurance and Regulatory departments. Works on complex problem in which analysis of data requires evaluation of identifiable factors. Be responsible for the development of new processes, optimization of the existing processes, and implementation of new or optimized processes.
- Provide support for technical issues related to the manufacturing process and product quality.
- Independent Extractable and Leachable studies including calculations of AETs and designing E&L studies.
- Be familiar with regulatory guidelines pertaining to process development/validation as well as implementing manufacturing process changes.
- Review and/or approve cGMP documentation generated by other scientists/technicians in the laboratory if necessary.
- Lead a given project which may involve a team of technicians and scientists with minimum supervision.
- Train new process development personnel on our manufacturing processes such as fractionation and purification processes
- Write and review SOPs, process development protocols, robustness study protocols, and process validation protocols.
- Write technical reports and present findings to internal or external clients.
- Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
- Identify areas of improvement in the manufacturing processes and develop appropriate analytical methods together with Analytical Development scientists.
- Support Analytical Development group in developing, improving and/or validating analytical methods pertinent to our test products.
- Perform testing as needed to generate data for Investigations pertinent to existing products.
- Analyze data generated from development/qualification and validation work using Excel or other software as required.
- Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by PD management.
- Maintain current knowledge in field of expertise.
- Minimum Bachelor s Degree, Master s Degree or PhD in Chemistry, Chemical Engineering, Biochemistry, Biological Sciences is preferred
- This position requires five to ten years of experience in Biologics, Chemical/Biochemical process development, including experience in a regulated environment (FDA, EPA, etc.). Knowledge of FDA cGMP requirements is an essential pre-requisite for this position. Experience with designing studies compliant with current USP requirements for extractables and leachables.
- Direct experience with developing and validating trace organic or inorganic methods to ICH Q2 requirements using chromatography and/or mass spectrometry.
- As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all of the 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. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.
- Thorough knowledge of cGMPs, FLPs, and regulatory principles. PC literate with intermediate proficiency in office application software. Detailed and current knowledge of US and international standards of viral safety and validation, and biotechnology techniques. Ability to development systems from literater base. Knowledge of polyolefin thermoplastic and butyl rubber additives and analysis methods. Good verbal and written communication skills and team skills.