Bioprocess Scientist

JOB RESPONSIBILITIES/DUTIES

- Assist with production planning and provide/support coordinating production activities across Fermentation, Purification, and Conjugation.
- Provides process execution and equipment operational activities in support of cGMP clinical and/or commercial manufacturing.
- Provides organizing role to ensure appropriate scheduling of activities and ensure production supplies are available for the day's operations.
- Work directly with peer Bioprocessing Technicians/Scientists to fulfil manufacturing requirements during the shift of operation.
- Conducts all activities that are in accordance with Company policies and SOPs, and global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.
- Advise management of non-conformance issues and opportunities for continuous improvement.
- Skilled manufacturing operations colleague with knowledge of microbial fermentation, purification, and conjugation processes in the production of microbial vaccines and biotherapeutics.
- Works as part of the production team and performs scientific and operational tasks related to clinical manufacturing.
- This position acts as production area operator working in a team environment with Bioprocessing Technicians and Scientists to execute processing and operational activities in support of manufacturing.
- Requires detailed knowledge of the operational aspects for Fermentation, Purification, and Conjugation processing to organize daily functions and work in concert with Bioprocessing Technicians and Scientists in executing those functions in a compliant, safe and efficient manner to maintain production schedules.
- Must be capable of assessing challenges to the schedule activities as necessary to minimize impact to quality, compliance and timelines.
- In addition to processing, cleaning, and operating major process equipment (tanks, fermenters, ultrafiltration units, lyophilizers, etc.), job duties also include routine production preparation tasks such as preparing production glassware and other equipment by operating industrial washers, autoclaves and depyrogenation ovens, use calibrated scales to weigh out dry components and use graduates and flasks to measure liquids.
- Performs laboratory activities such as: performing sample dilutions, pH, and conductivity readings.
- Requires understanding of scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on microbial fermentation/purification and conjugation processing.
- Capable of detecting technical problems and assisting the appropriate colleagues for resolution.
- Provides input and revises SOP's, batch records, forms or other cGMP related documents developed or revised to support continuous improvement efforts, investigation corrective actions, manufacturing operations, automation control (PLC, DeltaV, etc.) and regulatory audit commitments.
- May be required to attend and present at departmental meetings.

SKILLS:

EDUCATION

- AS degree with 4 years or greater of experience in a FDA regulated industry.
- BS degree with 1-4 years of experience in a FDA regulated industry.

SKILLS/QUALIFICATIONS

- Various years of experience within the biopharmaceutical industry, including knowledge and experience with relevant biopharmaceutical unit operations and/or laboratory operations.
- Experience should include operational and troubleshooting skills for biopharmaceutical processing equipment and/or analytical instrumentation.
- Manufacturing.
- Knowledgeable of process equipment and systems, manufacturing operations, and automation control (PLC, Delta V, etc)
- Knowledgeable of required processing unit operations and control systems needed for operations.
- Must be capable of cleaning, maintaining the facility in a cGMP environment.
- Ability to collect and assemble applicable, vital information to assist in troubleshooting and decision making.
- Must have experience within the bio pharmaceutical industry, Bioprocessing, GMP, GLP guidelines.
- Candidate must be open to working any type of shift.

PHYSICAL POSITION REQUIREMENTS

- Capable of sitting and/or standing for extended periods of time during the work shift.
- Must be able to work a rotating shift schedule to support a 24 hour manufacturing operation.