The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Bionova Scientific LLC

Job Description:

Company Summary:

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary:

The Validation Associate Director/Director plays a key leadership role in managing the Bionova Scientific (BNS) Validation program and ensuring that it is in alignment with Bionova and regulatory expectations. The position requires a leader that can build strong cross-functional relationships throughout the organization, manage and prioritize the different activities that are undertaken as part of a CDMO operation.  The role may be offered at the Associate Director or Director level depending on experience. The position may report into the Quality Unit or the Operations Unit or the Facilities and Engineering unit.  

The role will oversee the facility, systems and equipment qualification, including computerized system validation aspects to support Bulk Drug Substance (BDS) and Plasmid operations at Bionova Sites in Fremont, CA and Houston, TX.  The scope of responsibilities includes the entire facility to ensure Fit-for-Intended-Purpose in each area of GxP compliance (Development, Manufacturing, Laboratory, Clinical, Engineering, etc.) 

Essential Duties and Responsibilities:

• Member of the extended BNS senior leadership team. Serves as the Validation and Qualification subject matter expert (SME) and drives the validation and qualification strategy. 

• Maintains a state of inspection readiness and acts as main point of contact for Validation and Qualification activities towards client audits and Health Authority inspections. 

• Collaborate with Management to establish and meet targets and timelines in support of BNS’ Quality Management System, including validation program, change control, deviations, etc. 

• Identify, design, and implement process and system improvements. 

• Troubleshoot and direct the resolution of Validation issues by fostering effective cross-functional partnerships. 

• Manage validation personnel and project resources to accomplish defined scope of work and company goals. 
   

Specific Job Responsibilities

• Responsible for developing validation strategy and coordinating validation activities required to complete validation projects (equipment, CSV, utilities, and facility etc.) at the Fremont and Houston facilities according to the policies, procedures, and regulations. 

• Directs the strategy around the validation deliverables, CAPEX and expansion projects, ensuring new equipment and systems are implemented within predetermined timelines. 

• Implement Data Integrity by design as part of the Validation program. Coordinate the Data Integrity assessments and remediation as part of Bionova’s commercial readiness program 

• Lead cross functional teams/initiatives and act as individual contributor to drive validation activities, change control and improvement projects. 

• Write/Review/Approve validation related system lifecycle documents (user requirements, functional and design specifications, commissioning and qualification protocols/reports, plans, trace matrices, etc.), execute studies and report results utilizing sound science-based rationales and engineering principles to support qualification projects as required per current Good Manufacturing Practices (cGMPs). 

• Perform risk assessment and mitigation steps to maintain a validated state of compliance for all equipment, utilities, processes, materials, and facilities.   

• Manage the validation periodic review process, revalidation, and ongoing support of validated systems.   

• Prepare source documentation for regulatory filings as assigned, support or serve as a lead SME during regulatory inspections related to investigations, projects, and validation. 

• Procure and manage contractor support for outsourced validation assignments. 

• Provide input into the design and presentation of department performance metrics. 
   

Qualifications

• Director level: minimum of bachelor’s degree in engineering, Life Sciences, or related discipline with 15+ years of relevant experience in validation and qualification processes in pharmaceutical environments. A minimum of 5 years of direct management experience. 
• Associate Director level: minimum of bachelor’s degree in engineering, Life Sciences, or related discipline with 8+ years of relevant experience in validation and qualification processes in pharmaceutical environments. A minimum of 3 years of direct management experience. 
• Knowledge of Data Integrity and GAMP principles. 
• Flexible and agile mindset for a dynamic environment. 
• Strong project management capabilities. 
• Technical expertise to define validation approaches and execution of system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance. 
• Ability to independently evaluate technical situations and propose potential solutions. 
• Ability to communicate clearly and professionally in writing and verbally. 
• Basic understanding of data and statistical analysis of validation test results. 
• Flexibility with work hours to meet business needs. Willing to travel as the position supports BNS sites at Fremont and Texas 

Compensation Range: The base compensation range for this role is between $150,000 and $180,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.