Head of Analytical Operations

Reporting to: Chief Technology Officer

This an exciting opportunity for a well-qualified candidate to join Optieum Biotechnologies, Inc., a preclinical stage company focused on transforming the lives of patients with their proprietary Eumbody System, a platform technology that enables the development of advanced CAR constructs that optimize immune-cell function for oncology and other disease targets.

Reporting to the Chief Technology Officer this individual will (i) coordinate internal analytical activities the research and development groups and (ii) organize and manage external activities with contracted partners, initially in the USA then subsequently other geographies, for the development, validation, and execution of analytical methods for the characterization and Quality Control (QC) of the company’s therapeutic CAR T Cell product candidates.

Responsibilities

• Management of analytical operations for the characterization, QC batch release and QC stability testing of company products at Contract Development and Manufacturing Organizations (CDMOs) and other company contracted partners.
• Collaborate with internal research groups to develop and implement appropriate analytical methods for characterization of company products during preclinical development.
• Lead the development, transfer, validation, and implementation of analytical methods and QC testing at CDMOs and other company contracted partners.
• Review and approval of completed batch release and stability test records.

• Lead the investigation and resolution of analytical deviations and out-of-specification (OOS)/out-of-trend (OOT) events.
• Lead operational metric review processes, assess data for adverse trends, develop solutions and oversee implementation.

• Author, review, edit and/or approve documents such as test records, standard operating procedures, development/validation protocols and reports and Module 3 Common Technical Document (CTD) sections.
• Compile and manage timelines, budgets, and objectives.

• Collaborate with internal and external partners to maximize the efficiency of workflows and ensure supply chain security.

• Assist in negotiation of third-party contracts including clinical supply agreements and associated Quality Agreements.
• Other duties as may be assigned.

Job Requirements

• Hands on, high-energy leader who can operate in a fast-paced, entrepreneurial industrial environment.
• Strong computer and Internet skills with proficiency in Microsoft Office (Outlook, Excel, Word, Project & PowerPoint) as well as statistical analysis software.
• Strong interpersonal and collaborative management skills.
• Outstanding organizational skills.
• Excellent written and oral communication skills.
• Domestic and international travel will be required.
• Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates and externally with third party contract organizations.
• Self-motivated and detail-oriented, with the highest integrity.

Education and Skills

The ideal candidate for this position will have in-depth experience of the development, validation and execution of state-of-the-art analytical methods for the characterization and QC testing of cell therapy products (ideally CAR-T) and viral vector products.

Candidate must possess:

• Minimum BSc or equivalent in a scientific discipline with likely a Ph.D. or MS advanced degree in biological sciences or process engineering.
• Minimum of 10 years of experience in the biotechnology or pharma industry with a primary focus on the development, validation and execution of analytical methods and QC for cell-based therapeutics and/or viral vector products.
• Expert knowledge of state-of-the-art analytical methods for complex biologicals including cell therapy products and viral vector products.
• Demonstrated track record in successfully managing analytical and GMP QC operations at CDMOs.
• Demonstrated track record in successfully managing technology transfer, process development and GMP production operations at CDMOs.

• Excellent interpersonal and strong leadership skills with the ability to influence and liaise in a cross-functional team environment.

• Expert knowledge of GMPs and qualification/validation practices for viral vector and biologics products.

Headquartered in Ehime, Japan, Optieum Biotechnologies, Inc. (www.optieumbio.com) is a pre-clinical stage biotechnology company committed to developing innovative CAR-T cell therapies for treating patients with cancer. Optieum’s proprietary platform technology, the Eumbody System, enables the development of advanced CAR constructs that optimize immune-cell function for human disease targets