ABOUT US

Bioserv, a company of Sorrento Therapeutics, Inc. is a clinical stage and commercial biopharmaceutical company focused on delivering innovative and clinically meaningful therapies to address unmet medical needs. Our vision is to leverage our proprietary G-MAB™ library in conjunction with proprietary targeted delivery modalities to generate the next generation of therapeutics for treating cancer, autoimmune, inflammatory, viral and neurodegenerative diseases. These modalities include proprietary chimeric antigen receptor T-cell therapy (CAR-T), dimeric antigen receptor T-cell therapy (DAR-T™), antibody drug conjugates (ADCs), oncolytic virus (Seprehvec™), lymphatic drug targeting (SOFUSA®), as well as bispecific antibody approaches. We are additionally developing pain management solutions, including our clinical candidates resiniferatoxin (RTX) and SEMDEXA™. In response to the global SARS-CoV-2 (“COVID-19”) pandemic, we are also developing and conducting clinical studies for potential coronavirus antiviral therapies and vaccines, including Abivertinib, COVI-MSC™, COVI-AMG™, COVIDROPS™, and COVI SHIELD™, and diagnostic test solutions, such as COVISTIX™ and COVITRACK™.

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!

Sorrento Therapeutics, Inc. is a federal government contractor and, in compliance with its obligations under current federal regulations and guidance from the Safer Federal Workforce Task Force, Sorrento requires all employees, including newly hired employees, to present proof of vaccination against COVID-19, unless the employee is legally entitled to an accommodation. For further information, please refer to the Safer Federal Workforce Task Force’s 2021 Guidance for Federal Contractors and Subcontractors (Updated November 10, 2021), available at:

https://www.saferfederalworkforce.gov/contractors/.

WHAT WE ARE LOOKING FOR:

Target Salary Range ($80,000-$100,000)

Sorrento Therapeutics (“Sorrento”) is seeking an experienced Process Engineer to join our team.

WHAT YOU’LL DO:

This position provides process and equipment development skills and capabilities to develop, scale, and/or improve the quality and capability of manufacturing processes for internal or external clients. The role will coordinate equipment qualification and process validation tasks to ensure achievement of business unit objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide process engineering and development knowledge to external and internal client teams that are moving process from the laboratory environment to the cGMP manufacturing environment.
• Provide capability & coordinate process and manufacturing equipment specifications, installations, and start-ups, including compilation and creation of manuals, preventive maintenance activities, safety systems, and spare parts.
• Provide technical support to the Bioserv site personnel in manufacturing, QC, and Materials Management daily production operations.
• Demonstrate and lead a safety-first culture.
• Provide technical support to the Bioserv site personnel in manufacturing, QC, and Materials Management daily production operations.
• Support quality investigations as necessary to ensure timely completion.
• Assess, select, and manage external equipment vendors required to achieve pharmaceutical manufacturing objectives and capital plan.
• Develop clear and concise standard operating procedures and forms.
• Support and participate in internal and external audits and assessments as necessary (e.g. FDA, FMEA, etc.).
• Effectively interact with pharmaceutical process development, clinical development, and regulatory teams to achieve desired business objectives.
• Conduct focused and documented development studies to determine critical process parameters and associated process ranges.
• Develop strategies for process development, qualification, and validation efforts with clear scientific and regulatory rationale.
• Prepare and execute qualification documents for all process equipment to support GMP clinical and commercial manufacturing.
• Provide technical support in the generation of cGMP documentation (SOPs, Forms, etc.) to facilitate tech transfer, manufacturing, and regulatory submissions.
• As needed, independently plan, design, optimize, processes for manufacturing at pilot and GMP scale.
• Train personnel on process equipment and instrumentation as necessary.
• Perform critical analysis of processes for improvement and scalability.
• General lab tasks including ordering, organizing, and instrument maintenance.
• All other duties as assigned.

EDUCATION AND QUALIFICATIONS:

• Bachelor’s Degree in Engineering (Chemical or Mechanical Preferred) or related discipline
• Minimum of 4 years of experience in process and equipment development for the manufacture of pharmaceuticals or medical devices.
• Knowledge of cleanroom manufacturing environment and aseptic production.
• High level of initiative, ability to work hands-on, independently, multitask and work well in a fast-paced environment.
• Demonstrated success in process development, qualification, and validation of early and late phase clinical equipment used in the production of drug, medical device, or combination products.
• Demonstrated skills in documentation of qualification/validation protocols and Strong knowledge of GMP and all regulatory requirements as they relate to manufacturing activities.
• Excellent organizational and project management skills. Detail-focused with ability to multitask effectively and work efficiently within a strict timeline-driven environment.
• Ability to identify, select, manage, and negotiate with key partners and equipment vendors.
• Proficient in reading and evaluating engineering drawings.
• Ability to implement engineering/process designs from concept.
• Experience with control systems, PLC’s, SCADA, and BMS systems preferred but not required.
• Strong written and verbal communication skills including SOPs and technical reports. Communicates proactively and effectively with concise/relevant summaries.
• Ability to lift 25 lbs. is required.

YOUR REWARD:

• 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, company paid holidays, and Flexible PTO, plus equity-based compensation.

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 do not contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)