We are looking for a Process Development Scientist to join our client's team. This role is needed to conduct the implementation of highly complex production procedures to optimize manufacturing processes and regulatory requirements. Assists process development in developing complex scalable processes with improved product yield and reduced costs for manufacturing systems. This role is responsible for researching and implementing new methods and technologies to enhance operations.
location: San Diego, California
job type: Permanent
salary: $80,000 - 90,000 per year
work hours: 9 to 5
- Lead efforts to identify and resolve complex manufacturing issues (scope encompasses many and varied manufacturing or reagent processes)
- Identify and document sources of production inefficiencies and scrap and recommends solutions
- Develop/implement procedures to improve production processes
- Ensure junior level staff is trained and all training is properly documented
- Manage programs ensuring that new product design considers manufacturability and reliability
- Design and conduct complex experiments and multiple investigations on complex multivariate problems
- Investigate, develop, and establish complex analytical methods and define appropriate verification/validation requirements
- Develop, maintain, and present department metrics. Collect and analyze complex data source
- Participate in Lean Activities and ensure appropriate use of tools. Perform advanced statistical analyses of experimental data, Manufacturing or Chemistries Production test results. Uses results to identify trends, root causes, and variables affecting outputs
- Assist senior staff to establish department and corporate goals, milestones, and timelines for completion
- Carries out duties in compliance with established business policies.
- Perform other duties & projects as assigned.
- Bachelor's degree in Biology, Chemistry, Life Science, Engineering, other scientific discipline or equivalent
- Master's degree in Biology, Chemistry, Life Science, Engineering, other scientific discipline or equivalent highly preferred
- 10+ years of related experience
- Highly knowledgeable of regulatory guidelines including QSR, ISO 13485, and CMDR
- Skilled in the use of various database and data analysis programs
- Highly skilled in experimental design, RCA (Root Cause Analysis), statistical analysis and problem solving
- Expert on Manufacturing and Chemistries equipment and processes
skills: Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.