Hitachi Chemical Diagnostics, Inc.

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Chemist II

Title: Chemist II
Reports to: Production Supervisor
Department: Manufacturing
Status: Non-Exempt

General Summary/Objective (Purpose of position)

This position is located in Mountain View, CA. Under direct supervision, the Chemist II is primarily responsible for manufacturing Protein solutions, Buffers and Reagents. Duties also include performing in- process testing in accordance with established procedures and creating/updating documents.

Essential Duties and Responsibilities

  • Maintain and improve safety in the Wet Chemistry Lab.
  • Manufacture Optigen Dilution set, reagents, extracts, buffers and coupled solid phase according to cGMP, batch records, MOP, SOP and safety policies.
  • Ensure timely production and delivery of components to inventory.
  • Analyze and evaluate data for process improvements when necessary.
  • Perform in-process testing on reagents and extracts.
  • Write and revise BOM, MBR, MOP, SOP and related reports.
  • Run SDS gel and Western blot on extracts.
  • Identify and qualify new extract raw materials.
  • Train manufacturing personnel to formulate reagents, couple allergens and prepare extracts.
  • Properly handle and dispose of hazardous waste.
  • Review manufacturing documentation for completion and accuracy.

Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position)

  • Strong working knowledge of cGMP and standard laboratory methods.
  • Excellent math skills (Ratios, statistics).
  • Excellent knowledge in standard laboratory techniques such as filtration, gel electrophoresis, dialysis etc.
  • Proactive and critical thinking skills.
  • Ability to follow procedures.
  • Effective verbal and written communication skills in English.
  • Ability to work independently and in a team environment.

Education and Experience

  • Bachelor's degree in Biochemistry, Biological Sciences or Chemistry.
  • Minimum of (5) years’ experience in manufacturing in a cGMP environment of the biotech or pharmaceutical industry.

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

  • Laboratory Environment.
  • Exposure to a cold room (2-8°C) environment for up to 30 minutes continuously at a time.
  • Exposure to human blood serum and hazardous chemicals.
  • Must wear protective equipment such as safety glasses, laboratory coats, hairnets, face shields and any relevant equipment deemed as necessary.

Physical Demands

  • Ability to lift up to 50 pounds.
  • Ability to work in a cold room (2-8°C) environment for up to 30 minutes continuously at a time (Occasionally).
  • Ability to sit or stand, up to 2 hours continuously at a time and up to 8 hours total in a day.
  • Ability to visually discern printed characters as small as 1/16”.

Position type and expected hours of work

  • Full Time

Travel Demands

n/a

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

  • Clean supplies and equipment
  • Ensure equipment is in working order, calibrated and under Preventative Maintenance Program.

Additional Information

Affirmative action plan/equal employer opportunity (AAP/EEO) statement

Hitachi Chemical Diagnostics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Hitachi Chemical Diagnostics, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Disclaimer

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. Hitachi management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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