Manufacturing Project Coordinator
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
- As the Project Coordinator you'll be responsible for coordinating and running processes associated with the manufacture of the customer's drug product, medical device or reagents:
- You’ll be directly involved in the set-up, formulation, filling and lyophilization of buffers and solutions, and the timely completion of all associated documentation throughout the entire process.
- You will ensure that personnel follow all regulations and written procedures applicable to the job.
- You’ll also write procedures, perform validations, and investigate failures as necessary.
- You should be able to work with minimal instructions, and be able to provide some direction to area technicians.
- You will be working with Project Managers and 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.
- Bachelor's Degree in the biology or chemistry is preferred OR minimum of 3-4 years of college coursework in the sciences, or equivalent work experience is required.
- Minimum 3 – 4 years of experience in the pharmaceutical or related industry is preferred.
- Knowledge of GMP is required.
- Experience with both paper and electronic systems preferred.
- Experienced in basic word processing.
- Aseptic manufacturing experience is strongly preferred.
- Must be a team player, willing to learn, and able to work flexible hours.
- Physically you’ll be standing, sitting, controlled hand movements, repetitive motions, some pushing and pulling, and occasional heavy lifting up to 50 lbs.
YOUR DAY-TO-DAY WORK INCLUDES
- 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.
- Ordering materials, equipment and supplies for production.
- Prepare for jobs in advance by staging materials in the appropriate area.
- 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 wrapperpowder 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.
WHAT YOU’LL LIKE ABOUT US
- Innovative and Synergetic. You’ll enjoy our ever changing, but collaborative company culture.
- Rest and Relaxation. Three (3) weeks paid time off, 10 paid holidays,
- Benefits. Medical with HMO, PPO, HSA and FSA options, dental/vision, and stock options.
- Prepare for the Future. 401(k) with company match
If this sounds like the right career to fit your personality and interests, we’re looking forward to meeting you.
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Sorrento Therapeutics, Inc. is an Equal Opportunity Employer