Avid Bioservices
  • 27-Jun-2018 to 31-Aug-2018 (PST)
  • Manufacturing
  • CA, USA
  • Full Time

Medical & Dental Insurance, 15 days PTO per year, 8 company holidays, 4 floating holidays, 401k with company match, lunch and learns, annual wellness day and ESPP


Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.

We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today!

Relocation Bonus for Los Angeles/San Diego Residents Available!

Summary/Objective:

Manufacturing Technical Operations (MTO) Specialist is one of our Subject Matter Experts that provides the manufacturing process teams support as a technical resource, aids with complex tasks, and supplements routine operations. The Specialist, MTO will ensure the robustness of manufacturing processes and equipment by driving continuous improvements and applying best practices across manufacturing operations.  Our current role is focused on experts with Downstream Manufacturing skills.  This is a promotional opportunity for the right Sr. Manufacturing Associate who is ready to move up the career ladder.

Technical Duties/Responsibilities & Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • Function as SME on the production floor for Upstream and Downstream operations
  • Assist in the transfer of technology from Process Science (PS) and Manufacturing Quality Sciences (MQS) to cGMP Manufacturing.
  • Supplement Upstream and Downstream routine operations as needed
  • Resolve discrepancies and issues 'on-the-floor' per approved SOPs
  • Operate and troubleshoot issues with manufacturing equipment and processes in collaboration with Facilities (FAC), MQS, and Validation (VAL) departments.
  • Responsible for continuous process improvement and preparing/revising associated manufacturing/operation documents affected by these changes.
  • Assess new processes for 'manufacturability' and propose process changes to enable successful operations
  • Where issues or improvements are identified, will proactively execute viable solutions to reduce risk to operations
  • Will identify elements that can be made more efficient, are potential sources of discrepancies, require 'fine-tuning', or need complete revision.
  • Author discrepancies, perform investigations, and execute CAPAs as appropriate.
  • Author change requests as required
  • Prepare written reports and presentations and present at appropriate meetings as assigned.
  • Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms

Supervision Received:

The Manufacturing Specialist receives minimal supervision from the MTO Manager and/or area supervisor/manager and may perform routine duties with minimal supervision.

Position Type/Expected Hours of Work:

This role is a full-time exempt position with flexible scheduling due to operations/scheduling. The incumbent may be required to work weekends as necessary.

Education and/or Experience: 

  • A Bachelor's degree in life sciences or engineering is required.
  • Biopharmaceutical experience is required - the incumbent may possess 3 to 5 years in technical experience in industry or in graduate level studies, or equivalent combination of education and experience.
  • Minimum of 3 years' experience working with mammalian cell culture and/or purification.
  • Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence.      
  • Ability to speak effectively before groups of customers or employees of organization.

 EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or protected veteran status.

Avid Bioservices
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