Sr. Scientist Process Development
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: Sr. Scientist Process Development
- 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 scientific project management, technical proficiency, collaboration with others and quality systems. 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.
- Provide scientific project management oversight of Process Development and some Analytical Development projects.
- Coordinates quality systems documents, protocols and technical reports for Process Development and Analytical Development.
- Provide support for technical issues related to the manufacturing process characterization and product quality.
- Writes and/or reviews technical documents. Able to perform data review and data representation in documents and presentations.
- Be familiar with regulatory guidelines pertaining to process development/protein characterization as well as implementing manufacturing process changes.
- Lead a given project which may involve a team of technicians, scientists and cross-functional staff with minimum supervision.
- Analyze experimental data with appropriate statistical tools and report scientific results.
- Write and review Quality System documents for Deviations, Change Controls, CAPAs, SOPs, Protocols as necessary.
- Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by AD/PD/STO management.
- Work collaboratively in cross-functional teams.
- Liaison 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/PD/STO management.
- Interact with contract labs in support of various PD projects
- 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 or equivalent is desired.
- PMP Certificate preferred, but must have some project management experience. One would be responsible for presentations to the FDA and/or Management team.
- Five to ten years in similar environment with broad knowledge of biotechnology manufacturing, and protein separation/purification and/or characterization. Knowledge of FDA cGMP requirements is an essential pre-requisite for this position.
- 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.
- Thorough knowledge of cGMPs, GLPs, and regulatory principles. Proficient in office application software. Good communication skills, be detail-oriented, and able to work well with others. 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, Regulatory Affairs, Analytical Development, QC Chemistry, Manufacturing, and Receiving Department personnel. External: Frequent contact with vendors and distributors to exchange information, coordinate projects, solve problems and negotiate solutions.
- Direct Work of Others: Process Development Technicians or Scientists.
- Coordination of multiple projects and meeting deadlines, managing collaborations with other departments and outside contractors.