Wallingford, United States
about 1 month ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
We are currently seeking a Senior Manager Reagent Process Engineering in San Jose, CA.
As a (an) Senior Manager your day-to-day duties will consist of and may not be limited to:
Work with Engineering to develop programs, determine new methods, develop parameters, and determine material type for new or modified products. Provide direction to other workers where modifications and adjustments are required to meet specifications and ensure quality treatment.
Perform other duties as necessary to ensure production of parts to specification to include maintaining records.
The Senior Manager of Reagent Process Engineering will support the rapid growth of Consumables Reagent production within the San Jose, CA Site. The successful applicant will support and engage with members of the Consumables Manufacturing team, as well as a multidisciplinary team of engineers and scientists, to sustain and support antibody and protein conjugation, buffer formulation, capillary coating, and fluid dispensing processes.
- Technical leader and decision maker for transferring reagent formulation (proteins, antibodies, buffers), surface coating and fluid dispensing processes into production.
- Represent operations in NPI core teams and other transfer projects
- Create and write technical protocols (SOPs). Familiarity with Product Lifecycle Management, creating and submitting Change Orders, Standard Operating Procedures, Bills of Materials, and production documentation
- Identify and qualify alternate suppliers.
- Review product non-conformances, support and sustain manufacturing processes using good critical thinking skills
- Establish IQ/OQ/PQ of equipment used in biotech production (automation, motion control, liquid dispense, freeze drying, integrated electromechanical systems)
- Process Improvements
- Improve process robustness using production control and lean manufacturing principles
- Determine scale-up needs and execute projects to maintain growth trajectory
- Collaborate with R&D to re-define QC specifications, and design and execute validation studies.
- Plan validation exercises (Design of Experiments, FMEA) to demonstrate initial feasibility as well as manufacturing capability.
Education and Experience:
- Minimum 7 years’ experience working in manufacturing/production/process engineering.
- Minimum 5 years as a manager with direct reports in a related field.
- Experience with Lyophilization, Protein purification, conjugation is a plus.
- Working knowledge of chemical mixtures, polymers, and buffers.
- Track record in programming, setup, operation and troubleshooting of semi-automated equipment
- Experience with analytical equipment and assays, small scale plumbing process piping/lines and valves.
- Familiarity with handling hazardous materials, solvents, high pressure systems
- Silane/ surface chemistry or Solid works/ mechanical design experience is a plus
- Possesses high integrity and exceptional work ethic. Fosters mutual trust and respect and is a team player.
- Eager to train and give guidance to other employees
- Excellent communication and presentation skills
- Bachelor’s or advanced Degree in Engineering or Science (Chemical, Mechanical or Bioengineering, Chemistry, or relevant field)
Duration: Direct hire.
- Location: San Jose, CA