Manufacturing Technical Specialist (Downstream)

Avid Bioservices•Tustin, CA

1d•Onsite

About The Position

Avid Bioservices is seeking a Manufacturing Technical Specialist for its Downstream operations. This role is crucial for ensuring the successful transfer and execution of downstream processes, acting as a key technical support contact for Quality Assurance, Manufacturing Science and Technology (MSAT), and Facilities departments. The specialist will leverage strong leadership and deep technical expertise in scaling downstream processes, understanding manufacturing equipment, and setting up operations for success. This position involves collaborating with various internal teams, managing documentation, identifying process improvements, and leading technical training for manufacturing operators. The role also includes supporting investigations and recommending dispositions for manufacturing deviations.

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.
Oversee 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.
Develop and cultivate positive internal Avid group partnerships (MSAT, Facility, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.).
Oversee and approve 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.
Communicate with Client, MSAT, and QA on Process Status and collaborate to resolve technical issues on the floor.
Maintain and manage the equipment list and needs for all downstream processes.
Collaborate with facility and MSAT to ensure successful and sufficient equipment allocations for all processes.
Review Manufacturing Batch Production Records, Technical Reports, Standard Operating Procedures.
Lead technical training to Manufacturing Downstream Operators.
Support MFG Technical Supervisor/Manager in CAPA (Corrective Action Preventive Action) investigations and recommend dispositions for the manufacturing team.
Perform other tasks as assigned.