Sorrento Therapeutics Inc. is a fast growing, clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Sephrevir®”).
We attract smart people who play well with others. We’re small enough for your ideas to make a big impact, and large enough to offer you opportunities to grow professionally at any stage of your career.
If you’re a quick learner, enjoy working in the biotech industry, and share our mission of providing ground-breaking impact to medicine, each other, and our patients, Sorrento Therapeutics is the place for you!
WHAT YOU’LL DO:
- Create, review, and execute qualification protocols and documents for a variety of utility, facility and process equipment. This includes FATs, URSs, DQs, SATs, IQs, OQs, PQs, and associated validation lifecycle documentation, including identification and resolution of non-conformances/deviations.
- Develop validation documents with functional teams, ensuring the documentation meets regulatory requirements and quality standards.
- Collaborate with project stakeholders, engineers, SMEs, and cross functional team members to develop requirements (URS, etc.), related technical specifications, and other associated documentation.
- Initiate, process, and manage engineering change requests.
- Translate system requirement specifications into executable validation protocols.
- Provide equipment, system, software, and facility qualification guidance and strategy during project planning and development phases.
- Oversee and manage validation instrument inventory including validation equipment calibration.
- Perform temperature mapping and other miscellaneous validation activities.
- Manage Sorrento colleagues and contractors performing equipment and system qualifications.
- Report status and progress of qualification activities or projects.
- Perform investigations and implement corrective actions related to CAPAs and deviations.
- Support the execution of facilities & engineering projects.
- Author, Review and or approve scheduled periodic reviews.
- Author, Initiate, and/or review and approve SOPs related to compliance
- Other duties as assigned.
EDUCATION AND QUALIFICATIONS:
- BS degree in Engineering, Biotechnology or Life Sciences, Computer Science, IT or any other variety of engineering/technology education with 4 years of experience in Information Technology and computer system Compliance and/or Validation.
- 6+ years’ experience in FDA regulated environment with strong understanding of cGxP standards and Risk based validation.
- Knowledge of FDA guidance’s and industry standards (i.e., Quality Systems, GAMP, 21CFRPart11).
- Knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices.
- Experience in developing or reviewing Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices, and Validation Summary Reports.
- Read and interpret drawings such as PFDs, P&IDs and electrical schematics is preferred.
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; utility and facility validation experience is preferred; process validation experience is a plus.
- Knowledge of pharmaceutical manufacturing of biotechnology products, cell culture, aseptic processing, cell therapy processes and equipment is beneficial.
- Must be able to function and contribute as part of a team, have excellent communication skills, and contribute to team-based decisions.
- Ability to think critically and utilize troubleshooting and problem-solving skills.
- Ability to function efficiently and independently in a fast paced, changing environment.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description.
- Well-developed computer skills and fluent with Microsoft office applications.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
- Strong verbal and written communication skills.
Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
Earn a competitive salary that allows you to focus your attention on your passion.
A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and three-weeks’ PTO, plus stock options.
If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!
Principals only. Recruiters, please don’t contact this job poster.
Sorrento Therapeutics, Inc. is an Equal Opportunity Employer