Biomanufacturing Specialist

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.

• 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.