PhD degree with 7+ years of experience or MS degree or equivalent
with 10+ years experience or BS/BA or equivalent in Biochemistry, Biological Science,
Chemistry or Engineering with 15+ years experience in immunoassay development or engineering
in in-vitro diagnostics or the biotech or pharmaceutical industry. Previous supervisory
experience required.
Skills:
Strong knowledge of natural product extraction, purification, protein characterization and
immobilization to solid phase.
Comprehensive knowledge of biochemistry and immunology, with an emphasis on immunochemical
assays.
Proficient use of common laboratory equipment and instruments.
Ability to initiate and carry out manufacturing process development, process and equipment
validation (IQ/OQ/PQ), and production scale-up, including documentation and transfer to
manufacturing.
Ability to lead, coach and guide a technical group of chemists and engineers with a participatory
management style.
Strong trouble-shooting and risk analysis skills.
Ability to communicate effectively in English, both orally and in writing.
Able to lead and manage group in a cost-effective manner.
Strong computer skills (Excel, Word, Microsoft Project, Power Point, etc.)
Project management skills: planning, scheduling and executing.
Essential Functions:
Design, execute and document experiments and validations to resolve
technical issues, scale up processes, improve processes and transfer processes and
equipment into a cGMP manufacturing environment while complying with QSR and ISO13485.
Analyze and evaluate data and document findings. Make and implement
recommendations supported by results.
Develop and validate chemical, biochemical, and physical analytical
methods to evaluate raw materials and components, and transfer methods to Quality
Assurance.
Manage the factory scale-up of the OPTIGEN product line, including
facilities, instrumentation and process improvement
Evaluate and investigate raw materials to develop production
specifications.
Continuous improvement of current products including conjugates and
reagents.
Perform foil pouching of pettes.
Perform verifications of manufacturing operations.
Maintain operating and capital budget for department.
Responsible for managing scientist and engineering team.
Additional Responsibilities
Train Manufacturing and QA personnel to perform new methods and
operate new equipment being transferred and document the training.
Manage other projects as necessary.
Perform other duties as necessary.
Physical Demands
Position requires the abilities to walk, sit, stand, left and
carry up to 25 pounds, hear, understand and convey verbal communications of and to other
personnel and the ability to visually discern printed characters as small as 1/16”; close
and distant vision. Extended working hours will be necessary at times.
Work Environment
While performing the essential functions of this position the
employee will work with chemical and hazardous materials and work in a refrigerated area
for up to 30 minutes.
Submit Resume or CV to:
Human Resources
Hitachi Chemical Diagnostics
630 Clyde Court
Mountain View, CA 94043
Fax: 650 969 2745
E-mail: webmaster@hcdiagnostics.com
Subject: Sr. Process Engineering Manager
hitachi.com 
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