Associate Director of Analytical Testing Services

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.

Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 30 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients’ needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique’s experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner.

Company:

Bionique Testing Laboratories LLC

Job Description:

The Associate Director focuses on leading the implementation and management of new analytical testing services, to include sterility (traditional and alternative rapid methods) and endotoxin testing for biopharma product samples. This role will work closely with the CSO and CEO to finalize the new testing services roadmap and will initially serve as the lead project manager for onboarding these testing services including assisting with establishing necessary SOPs, LIMS workflows, and training programs, with the ultimate responsibility of managing and ensuring their operational excellence in accordance with Company and regulatory policies and procedures.  In addition to managing testing services, this position will spearhead the development and implementation of a robust environmental monitoring (EM) program and on-board identification processes to support sterility and EM efforts. The Associate Director will collaborate with other departments and will champion Company policies, mission, and vision.

Key Accountabilities and Responsibilities:

• Leads the project management efforts for the on-boarding of new analytical testing services to include sterility (traditional and alternative/rapid methods) and endotoxin testing within budget and agreed upon timelines

• Manages and directs all activities, P&L, and operations for new analytical testing services in accordance with cGMP guidelines and regulatory requirements

• Prioritizes the activities of the sterility and endotoxin testing group to ensure key goals are achieved and customer service needs are addressed, including meeting on-time delivery timelines

• Evaluates performance of the sterility and endotoxin operations by establishing, analyzing and interpreting data and metrics

• Provides progress updates on status of the operations, strategic initiatives and projects as well as other matters of importance to CEO/CSO and other stakeholders

• Implements and oversees an effective environmental monitoring (EM) program, ensuring compliance with regulatory standards

• Collaborates with internal stakeholders to establish and optimize processes for microbial identification in support of sterility and EM initiatives

• Works closely with quality assurance to develop and maintain SOPs, protocols, and training programs related to new testing services

• Drives continuous improvement initiatives to enhance efficiency, quality, and compliance of testing operations

• Ensures all personnel, including contractors, consultants and employees have the proper qualifications, skill sets, education and training to perform their job in accordance with procedures and regulations

• Represents the organization with Regulatory Authorities/Client Inspections and always maintains laboratory in an audit readiness state, managing lab inspection preparations and executions by Regulatory Agencies such as FDA, Health Canada and EMEA regulators

• Stays current with industry trends, regulatory developments, and technological advancements related to microbiology testing in a cGMP environment

• May represent the company at various professional and educational conferences providing scientific expertise and content (poster and/or podium)

• Provides leadership and mentorship to team members, fostering a culture of accountability, collaboration, and excellence

• Additional related duties as assigned

Additional Accountabilities and Responsibilities

• Works independently and proactively

• Ability to manage multiple competing priorities with successful follow-through and timely delivery

• Ensures the overall management of the department, including but not limited to budget, supervisory duties such as performance management as well as workforce planning to support operations, and the decision-making process

• Creates an engaging work environment and climate, including a growth-oriented mindset, for the team

• May serve as a delegated backup for CSO as appropriate

Requirements:

• Graduate degree (Master’s, Doctorate, or equivalent) in Microbiology, Biology, Biochemistry, or related scientific discipline

• Minimum 5 years of progressive experience in a cGMP testing laboratory environment, with specific expertise in sterility testing project management

• Demonstrated experience and expertise in leading and managing sterility testing programs, including traditional and rapid/alternative methods

• Strong understanding of FDA and other regulatory guidelines pertaining to microbiology testing and cGMP requirements

• Proven track record of successfully implementing new testing services and programs within a regulated environment

• Prior experience with LIMS implementation a plus (LabVantage preferred)

• Excellent leadership and communication skills, with the ability to effectively collaborate across functions and levels of the organization

• Detail-oriented with strong analytical and problem-solving capabilities

• Creative and able to adapt quickly to change

• Experience in personnel management, including training, coaching, and performance management, is preferred

• Excellent IT skills including but not limited to Microsoft Office Suite, etc.

Physical Requirements:

• Prolonged periods of sitting on a chair, working at a desk and working on a computer and/or telephone

• Must be able to lift up to 40 pounds

Pay Rate:

• The base compensation range for this role is $110,000-$170,000. Base Compensation is influenced by many factors including, but not limited to: position level, time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.  Please keep in mind that the range mentioned above is the full base salary range for the role. Hiring at the maximum of the range would not be typical in order to allow for future & continued salary growth.

• Relocation assistance may be available.

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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.

Salary : $110,000 - $170,000