Manufacturing Technical Specialist, Downstream

Avid Bioservices; Tustin (CA); On-site; USD 59,000 - 74,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California is seeking a Downstream - Manufacturing Technical Specialist to collaborate with the technical MFG Supervisor/Manager, ensuring successful transfer and execution of Downstream processes and acting as the main contact for QA, MSAT, and Facility.

You will assist with training, maintain equipment lists and calibration schedules, coordinate readiness for manufacturing, review Batch Production Records, lead downstream training, and support CAPA investigations to improve

Qualifications

• B.S./M.S. in chemical or biomedical engineering or related field.
• 4+ years in downstream manufacturing with B.S.; 2+ years with M.S.
• Experience with cGMP manufacturing and downstream unit operations.

Responsibilities

• Collaborate with MFG Supervisor/Manager to transfer downstream processes.
• Serve as main contact for QA, MSAT, and Facility for technical support.
• Assist training, maintain equipment lists and calibration schedules.
• Coordinate readiness with Facility and MSAT for manufacturing processes.
• Lead technical training for Downstream Operators and support CAPA investigations.

Skills

Leadership

Communication

Time management

Team collaboration

Problem solving

Education

B.S./M.S. in chemical or biomedical engineering

Tools

AKTA chromatography

Unicorn software

Large-scale filtration skids

Job description

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.

Key Responsibilities:

• 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.

Minimum Qualifications:

• 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 escalation 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.

Position Type/Expected Hours of Work:

This role is a full-time position operating Monday through Friday, 5x8 (5 days x 8 hours) schedule from 8am to 5pm PST unless otherwise stated by Supervisor. Must be able to work overtime, weekends, and/or holidays if needed.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $59,200 - $74,000 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.