Advanced Research Associate, GMP Production
By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.
Position Summary:
This position is responsible for cellular processing in a regulated environment, following GMP guidelines. The Advanced Research Associate will be responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of cell therapy production and/or human cell cultivation. This includes, but is not limited to technical transfer, engineering runs, process qualifications, and cGMP production runs used by pharma and other CDMO customers. Documents batch records following GMP guidelines. This position must be flexible in nature to be able to handle a variety of cellular processing from T cells, mesenchymal stem cells to pluripotent stem cells.
Key Responsibilities:
- Produce clinical and commercial material that meets the site’s strategic objects and is compliant with cGMPs and safety regulations.
- Process development and technical transfer of customer procedures into SOPs
- Completes Batch Production Records under cGMP, and documents in detail using SOPs for the processes and manufacturing steps
- Collaborating with the Process Development to transfer new projects into GMP protocols.
- Genome engineering cells under cGMP conditions.
- Draft raw material specifications forms
- Cell culture experience at small to large scale capacity and familiarity with pluripotent stem cells, T cells, NK cells, MSCs and transformed cell lines.
- Cleaning and operating within GMP products in an ISO 7 cleanroom.
- Cleans, validates equipment and procedures, and ensures the lab is ready for internal and external audits.
- Revises specifications, SOP’s and documents as needed, and submits to manager for review.
- Ensures chemicals, stock buffers, and equipment calibration are up to date. Submits orders to restock chemicals, raw materials, and consumables when needed.
- Follows company policies and practices as outlined in Handbook and follow guidelines regarding safety as outline in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.
- Identify, develop and implement process improvements
- Work with the manufacturing team to close deviation and the closure of CAPAs
- Recommend equipment and other supply purchases within the production areas
- Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
- Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
- Adhere to all cGMP manufacturing operations, documentation and safety guidelines
- Post-production; prepare all GMP documentation for hierarchy approval.
Job Qualifications
Education and Experience:
- B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field with 3-5 years of relevant experience; OR Master's degree in related field and up to 2 years of relevant experience AND 0 - 2 years of experience in biopharmaceutical based GMP manufacturing operations/Cell Therapy/Human Cell Cultivation
Knowledge, Skills, and Abilities:
- Ability to work in a clean room gowned environment and use aseptic techniques.
- Experience with cellular processing at small and large scale cell culture of human cells preferred
- Experience with reprogramming into iPSCs is recommended
- Experience with genome engineering is recommended
- Knowledge and experience of transfection techniques such as electroporation
- Demonstrated technical knowledge of bioreactors, disposable technology and aseptic processing a must
- Demonstrated technical knowledge of molecular biology and genome engineering
- Experience with flow cytometry techniques and ability to independently operate a flow machine
- Knowledge of computers and Microsoft Office programs such as Word, Excel, and Outlook.
- Skill in establishing effective interpersonal relationships such as the ability to solicit key ideas and information.
- Skills in planning, organizational, time management and multi-tasking.
- Excellent verbal and written communication skills including technical writing skills.
- Knowledge of safety and company rules and policies.
- Ability to handle sensitive and proprietary information with discretion and confidentiality.
- Solid knowledge of FDA regulations and GMP systems.
- Excellent oral and written communication skills. Strong technical writing ability required.
- Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
- Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.