Manufacturing Associate 1 or 2 - San Diego, United States - Capricor Inc

Capricor Inc

Verified Company

San Diego, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Position:
Manufacturing Associate I/II

This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support Capricor's clinical trials and exosome development.

We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.

Responsibilities:

Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
Compiling data for documentation of test procedures and reporting abnormalities
Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
Authoring, revising and updating standard operating procedures using the document change system
Maintaining broad knowledge of stateoftheart principles and theories
Maintaining inventory, material transfers and cleanroomrequired activities to support cGMP operations
Preparing technical summaries, protocols and reports
Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
Performing special manufacturing and development projects

Requirements:

Bachelor's degree in Biomedical Engineering, Biological Sciences or related field
13 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
Laboratory experience in mammalian tissue culture is required
Excellent aseptic technique, knowledge of aseptic practices
Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
Exceptional communication and interpersonal skills
Excellent organizational skills and attention to detail
Ability to work in a dynamic environment
Basic molecular biological and flow cytometry skills are preferred
Adaptable/flexible with work schedule with an ability to multitask and prioritize work

Work Environment/Physical Demands:

Must be able to sit and stand for extended periods.
Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.
Able to fully gown and work in a manufacturing area.
Work extended or off hours depending on the company needs to respond to manufacturing schedule (including weekends, holidays), as required