Project Coordinator - Bioserv

· San Diego, California
Employment Type Full-Time
Minimum Experience Mid-level
Compensation DOE+Benefits+Options

ABOUT US


Bioserv, a Sorrento Company, is a leading contract manufacturing service provider whose core competencies are centered in aseptic and non-aseptic drug, medical device or reagent manufacturing; bulk formulation filtration; fill/finish; lyophilization services; labeling and finished goods assembly; kitting and packaging; as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II Clinical Trial drug products.


WHAT YOU’LL DO:


The Project Coordinator is responsible for coordinating and running processes associated with the manufacture of the customer's product in manufacturing. This includes working with Project Managers in communication with the customer, ensuring  inventory  is available to begin the process, and coordinating the scheduling of the job including the needs of personnel, equipment and space. The Project Coordinator is directly involved  in the set-up, formulation and aseptic filling and lyophilization of buffers and solutions, and the timely completion of all associated documentation throughout the entire process. They are to ensure that personnel follow all regulations and written procedures applicable to the job. Project Coordinators will also write procedures, perform validations, and investigate failures as necessary. The ideal candidate should be able to work with minimal instructions, and should be able to provide some direction to area technicians.


Essential Duties & Responsibilities


  • Manufacture of product as assigned by management in compliance with applicable regulations (e.g. cGMP, ISO's, QSRs) with minimal direction from the Manufacturing Supervisor; follow written procedures and verbal instructions
  • Order materials, equipment and supplies for production
  • Prepare for jobs in advance by staging materials in the appropriate areas
  • Coordinate the scheduling of product, space, and equipment with management
  • Perform aseptic formulations of buffers and solutions
  • Perform aseptic filtration and filling operations
  • Ability to operate a variety of equipment without assistance or direction, including but not limited to: shrink wrapper, powder filler, liquid filler, torque wrench, pH meter, conductivity meter, dry heat oven, mixer, lyophilizer, autoclave and other equipment related to manufacturing
  • Oversee and direct all jobs on the production floor with Manufacturing Supervisor
  • Perform a daily review of all documentation on the production floor for completeness
  • Ensure that all products are properly identified in all phases of manufacture
  • Perform other activities as assigned by management
  • Meet production deadlines in a dynamic manufacturing environment
  • Perform equipment and process validations as required
  • Identify discrepancies during manufacturing activities and notify Manufacturing Supervisor, and QA to ensure actions are taken in a timely manner to prevent deviations and non­ conformances due to incorrect documentation
  • Assist with other cross functional teams on an as needed basis to ensure company's goals and objectives are met


EDUCATION AND QUALIFICATIONS:


Education Required


Bachelor's Degree biology or chemistry  is preferred; minimum of 3-4 years of college coursework in the sciences, or equivalent work experience is required


Experienced Required


3 - 4 years of experience in the pharmaceutical or related industry is preferred; experience with both paper and electronic systems preferred; experienced in basic word processing.


Specialized or Technical Knowledge, Licenses, or Certificates Needed


Knowledge of GMPs required. Aseptic manufacturing experience is strongly preferred. Must be a team player, willing to learn, and able to work flexible hours. Occasional heavy lifting up to 50lbs, standing, sitting, controlled hand movements, repetitive motions, some pushing and pulling.


YOUR REWARD:


  • Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
  • Earn a competitive salary that allows you to focus your attention on your passion.
  • A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and three-weeks’ PTO, plus stock options.


If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!


Principals only. Recruiters, please don't contact this job poster.


Sorrento Therapeutics, Inc. is an Equal Opportunity Employer

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  • Location
    San Diego, California
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level
  • Compensation
    DOE+Benefits+Options