Careers

Position Description: Manufacturing Associate

Job Title: Manufacturing Associate
Location: La Jolla, CA
Department: Manufacturing
Reports To: Manager, Manufacturing

Summary

The Manufacturing Associate is responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Responsible for following SOPs, performing daily tasks in a cleanroom per the current QSRs, retaining records and writing reports. May also be responsible for troubleshooting. Follows established company rules, regulations and safety precautions, and ensures that high standards of Quality and Teamwork are adhered to.

ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this position include the following, although other duties may be assigned.

Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation.

Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.

Performs production related tasks as assigned by the Area Supervisor or Group Lead. These tasks can include, but are not limited to, such things as maintaining equipment lists, coordinating calibration/PM schedules with Facilities, ordering supplies and/or equipment for Production, ordering documents for Manufacturing, assisting with training new employees, initiating change orders and SCRs etc.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

Requires a minimum of 2 to 4 years’ experience with a high school diploma or 0-2 years with a Bachelors degree in life science or related area. Must be an independent thinker with the ability to plan and execute duties with minimal oversight. Has hands-on experience with commonly used production concepts, practices, and procedures such as cell culture, and aseptic technique.

General knowledge of cleanroom practices, familiarity with Good Manufacturing Practices (GMP).

Language Skills

Ability to read, and interpret SOPs and Batch records written in English. Ability to document activities clearly and neatly.

Mathematical Skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to add and subtract two digit numbers and to multiply and divide with 10's and 100's. Ability to perform these operations using weight measurement, volume, and distance

Reasoning Ability

Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Must be detail-oriented, able to follow detailed instructions, set priorities, and organize daily work requirements. A wide degree of creativity and latitude is expected. Manufacturing Associates must be able to work as a team member and interact closely for long periods of time with various types of personalities.

CERTIFICATES, LICENSES, REGISTRATIONS

None required.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working in a cleanroom environment required. Must clothe in cleanroom gowns to perform duties. Must be able to lift/push 50 lbs. Many manipulations performed which require good eye/hand coordination. Must have good seeing ability in order to inspect culture, assemblies and packaging. Must have good talking and hearing abilities in order to interact with team. Must work with living human cells and various chemicals. Generally, chemicals used are not toxic or extremely dangerous. However, precautions must be taken with all chemicals, solutions and cultures. Due to the nature of Production work overtime and weekend work is a requirement of employment though it may vary depending on the season and production needs of the company.

We are an Equal Opportunity Employer.