Sr. Scientist, Analytical Development

Employment Type

: Full-Time

Industry

: Miscellaneous



Avid Bioservices Inc., located in Tustin CA, is a dedicated contract development and manufacturing organization ('CDMO') focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture. Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. Avid also provides a variety of process development activities, including 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! In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Covid-19 Hiring Update: We are continuing to interview and hire during this time. Avid Bioservices' is committed to caring for the safety and well-being of applicants and employees; all interviews will be completed over the phone or virtually. Summary/Objective: The Senior Scientist will support the Analytical Development group related to all viral vector testing activities/initiatives. He/she will manage testing and characterization of viral vector products as well as in process production and purification intermediates. The Sr. Scientist will ensure that the required assays related to identity, potency, purity, safety and stability are being developed, transferred and implemented. He/she will support the transfer of assays to Quality Control and ensure qualification and validation based on product/clinical trial phase. The Sr. Scientist will participate in testing activities related to new process scale-up, process optimization, technology transfer and process validation activities. Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) * Undertakes complex and multi-faceted client and innovation programs. * Applies established platform approaches and utilize problem-solving skills to rapidly solve day to day testing challenges * Designs and Performs experiments at the bench and pilot scales, spanning all aspects of testing and characterization of viral vector products, intermediates, contaminants and residuals. * Interacts with other Process Development functions to provide the needed support for in-process testing related to viral vector and protein production and purification processes. * Develop state-of-the art assays and ensure all testing meets regulatory requirements for viral vectors and vaccines * Communicates work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings * Participates in cross-functional teams and interact with representatives from Process Development, Project Management, Manufacturing, and Quality to arrive at and implement viable / practical solutions to support clinical/commercial manufacturing * utilizes design of experiments and statistical analysis of data * Will interface with client and must be articulate around the science and problem solving * Supervises a team of scientists and research associates * Manage timelines and coordinate resources with function heads to ensure project deliverables are achieved * Perform other duties as assigned Required Education and Experience: PhD in Molecular Biology, chemistry, biochemistry, chemical/biochemical engineering or related disciplines with a minimum 5 years of technical experience in testing and characterization of viral vectors or large molecules. Knowledge of regulatory requirements (national and international). Managerial experience with proven capability as a successful leader. Good business acumen and critical thinking. Knowledge of process characterization and validation. Experience with assay transfer to Quality Control. Knowledge of CGMP's and relevant regulatory requirements. Excellent interpersonal communication and presentation skills. Supervisory Responsibilities: Directs activities of functional areas through manager, supervisor and scientist level employees. Position Type/Expected Hours of Work: This role is a full-time exempt position. Days of work are Monday through Friday unless otherwise stated by Supervisor or needed due to projects. Must be available to work holidays, weekends, or extended hours when needed. Travel: Occasional travel by land and/or air may be required to attend seminars or conferences or client meetings. 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.

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