Biomanufacturing Specialist
5 days ago
Planet Phar is seeking a highly skilled Biomanufacturing Specialist to join our team. As a Biomanufacturing Specialist, you will be responsible for the manufacturing operations to support production from start-to-finish of device and biologic products.
Key Responsibilities:- Manufacturing operations to support production from start-to-finish of device and biologic products.
- Processing upstream raw materials (porcine tissue).
- Manufacturing downstream final device.
- Manufacturing downstream final biologic.
- Aseptic fill & finish.
- Filtration.
- Set-up and operate specialty equipment.
- Preparation of reagents.
- Tissue inspection and handling.
- Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs.
- Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule.
- Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner.
- Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends.
- Sterilization – Autoclave.
- Lyophilization.
- In-process testing.
- Release testing.
- Assist with ongoing product research and development projects.
- Work with team to investigate and qualify equipment needed for developed products and/or products in research and development stage.
- Assist with preparation of large-scale raw materials for processing and purification.
- Assist with maintaining laboratory equipment and instrumentation required for processing of material, or process control.
- Become familiar with equipment and the overall processes in order to make recommendations based on results.
- Assist Quality in preparation and completion of documentation, following cGMP practices.
- Follow GMP requirements and procedures.
- Work with a team to provide consistent quality product at high efficiency.
- Perform other tasks, as assigned.
- Bachelor's degree or higher with experience in biochemistry, molecular biology, biology, or engineering principles preferred but not required, with equivalent past experience.
- Ability to work in a cleanroom for 1-2 hours at a time.
- Experience with a broad range of production and test/inspection equipment and ability to do minor maintenance on equipment.
- Ability to work independently, and also collaborate as part of a multi-disciplinary team.
- Demonstrated ability to be highly organized and manage multiple priorities.
- Effective communication skills, both verbally and written.
- Good work ethic, reliable, and punctual.
- Strict adherence to established protocols.
- Flexibility to handle new and changing process steps / tests as they evolve.
- Proficiency in general laboratory techniques (e.g., pipette, sterile technique, weigh, titrate, reagent preparation).
- Must have a desire to be part of a fast-paced and dynamic environment.
- Ability to lift 15-25 pounds and stand for prolonged periods.
- cGMP/GLP experience preferred.
- Experience with plate-based assays (e.g., colorimetric, ELISA).
- Experience with mechanical testing.
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Biomanufacturing Specialist
4 days ago
Reston, Virginia, United States Kelly Science, Engineering, Technology & Telecom Full timeManufacturing Specialist (Contract 6 months)Location: Winston Salem, NCHourly Pay Rate: $20-$25 DOEJob Type: ContractShifts: Sunday-Tuesday 6am-7pm and Wednesday 7am-2pmThursday-Saturday 6am-7pm and Wednesday 11am-6pmKelly Science is seeking a skilled Manufacturing Specialist to work with a cutting-edge technology-based client within the biotechnology...