Manufacturing Technical Specialist (Downstream)

Avid Bioservices•Tustin, CA

6d•$25 - $34

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The primary responsibilities of the Downstream - Manufacturing Technical Specialist are to collaborate with the technical MFG Supervisor/Manager to ensure the successful transfer and execution of Downstream processes, and to serve as the main point of contact for QA, MSAT, and Facility for Downstream technical support. This role requires strong leadership skills and deep technical knowledge in scaling downstream processes, as well as an understanding of MFG Downstream equipment, processes, and the setup of Manufacturing Downstream Operations for success. The MFG Technical Specialist supports the MFG Technical Supervisor/Manager in overseeing the transfer of all new projects and any changes to existing projects from MSAT to manufacturing. They will assist MFG Leads in the progress of technical and on-the-job training for the MFG team; as well as aid in maintaining the equipment list and calibration/PM schedule and will coordinate with Facility and MSAT to ensure successful equipment readiness for all manufacturing processes. Develops and cultivates positive internal Avid group (MSAT, Facility, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships. Working with MFG Technical Supervisor/Manager in Overseeing and approving the BPR, Unicorn method, BOM, and buffer and solution planning as the manufacturing stakeholder. Working with MFG Technical Supervisor/Manager to identify and initiate process and procedural changes to improve performance, robustness, productivity, safety, efficiency, and compliance. Communicating with Client, MSAT, and QA on Process Status and collaborating to resolve technical issues on the floor. Maintaining and managing the equipment list and needs for all downstream processes. Collaborating with facility and MSAT to ensure successful and sufficient equipment allocations for all processes. Reviewing Manufacturing Batch Production Records, Technical Reports, Standard Operating Procedures. Leading technical training to Manufacturing Downstream Operators. Supporting MFG Technical Supervisor/Manager in CAPA (Corrective Action Preventive Action) investigations and recommending dispositions for the manufacturing team. Other tasks may be assigned as needed.

Requirements

B.S/M.S. in scientific or engineering (chemical or biomedical) discipline.
4+ years of Experience downstream MFG with B.S and 2+ years with M.S.
Strong technical experience within relevant manufacturing process technologies and unit operations. Experience of commercial cGMP manufacturing.
Technical expertise in Downstream processes such as depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.
Hands-on experience with downstream process equipment including, but not limited to AKTA ready column chromatography skids, large-scale filtration skids, Unicorn software.
Track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles.
The ability to work effectively and lead small matrix and cross-functional teams in a fast-paced environment with changing priorities and a high level of urgency.
Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams.
Customer service skillset via escorting of person in plant (PIP) or through prior work experience.
Strong knowledge of cGMPs or equivalent standards.
Sound decision-making skillset to resolve or escalate deviations and/or issues on the production floor.
Communicate clearly and professionally both in writing and verbally.
Proficient time management/multi-tasking and project oversite skills.
Strong leadership and management skillset.

Responsibilities

Collaborate with the technical MFG Supervisor/Manager to ensure the successful transfer and execution of Downstream processes
Serve as the main point of contact for QA, MSAT, and Facility for Downstream technical support
Overseeing the transfer of all new projects and any changes to existing projects from MSAT to manufacturing
Assist MFG Leads in the progress of technical and on-the-job training for the MFG team
Aid in maintaining the equipment list and calibration/PM schedule
Coordinate with Facility and MSAT to ensure successful equipment readiness for all manufacturing processes
Develops and cultivates positive internal Avid group (MSAT, Facility, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships
Overseeing and approving the BPR, Unicorn method, BOM, and buffer and solution planning as the manufacturing stakeholder
Identify and initiate process and procedural changes to improve performance, robustness, productivity, safety, efficiency, and compliance
Communicating with Client, MSAT, and QA on Process Status and collaborating to resolve technical issues on the floor
Maintaining and managing the equipment list and needs for all downstream processes
Collaborating with facility and MSAT to ensure successful and sufficient equipment allocations for all processes
Reviewing Manufacturing Batch Production Records, Technical Reports, Standard Operating Procedures
Leading technical training to Manufacturing Downstream Operators
Supporting MFG Technical Supervisor/Manager in CAPA (Corrective Action Preventive Action) investigations and recommending dispositions for the manufacturing team
Other tasks may be assigned as needed