Sr. Specialist, Downstream Manufacturing Quality Sciences

Avid Bioservices Garden Grove, CA
Are you a problem-solver with biologics purification experience looking for a new opportunity to practice your critical thinking skills to provide innovate solutions to the technical field of process sciences and downstream manufacturing quality sciences? We have an opportunity for you to assist in improving patient lives through our manufacturing operations for clinical trial products!

Avid Bioservices is an established Contract Development and Manufacturing Organization (CDMO) of clinical and commercial products with an outstanding track record of 25 years. We are dedicated to the improvement of global patient outcomes by delivering world-class services for the development and manufacture of biopharmaceuticals. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch in the flight to support patient innovative therapies across a variety of diseases.

Summary/Objective:

* The Sr. Specialist, Downstream Manufacturing Quality Sciences will review 'Engineering Run' Batch Records prior to final QA review and approval.

* Assist in the technical transfer of process from client (s) and/or Process Sciences to Manufacturing scale. Responsible for continuous process improvement in all manufactured products.

* Where issues or improvements are identified, this role will propose viable solutions including a final product impact assessment. Will identify elements that can be made more efficient, are potential sources of discrepancies, require 'fine-tuning', or need a complete revision.

* Review all discrepancies, oversee investigation activities and prepare a CAPA as appropriate. Propose innovative methods/procedures for gap analysis and reduction of deviations.

* Will prepare written reports and presentations for meetings as assigned.

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 Downstream operations

* Actively participate in the technology transfer from Process Science (PS) to cGMP Manufacturing.

* Design and execute studies to support MFG production.

* Perform gap analyses on tech transfers.

* Write technical risk assessments.

* Identify and implement efficiencies for manufacturing processes.

* Ability to quickly identify process issues and resolve them expeditiously

* Ability to perform sound root cause investigations and identify correct CAPAs

* Review batch production records for engineering runs

Supervision Received: General supervision: routine duties are performed with minimal supervision; standard practices or procedures allow analyst to proceed alone at routine work; work is reviewed upon completion.

Position Type/Expected Hours of Work: This role is a full-time position with flexible scheduling due to operations/scheduling. General days and hours of work are Monday through Friday 8:00am to 5:00pm, unless otherwise stated by Supervisor. The incumbent may be required to work weekends as necessary.

Education and/or Experience:

* A Bachelor's degree in life sciences or engineering or higher 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 biologics purification.

* Ability to think creatively to address complex problems.

* Ability to understand chromatography theory, viral filtration, and ultrafiltration and be able to apply it to real-time scenarios.

* 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 technical 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 because he or she is a protected veteran.