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:

Summary:

This position is responsible for ensuring a state of continuous GMP compliance of Bionique’s services and activities. This requires a combination of regulatory knowledge, attention to detail, effective communication, and a commitment to continuous improvement with the goal of achieving compliance to applicable regulatory requirements and obligations throughout the organization and ensuring that appropriate control measures are in place.

Key Accountabilities and Responsibilities:

Effectively communicates and proactively seeks resolution to compliance matters in accordance with internal and regulatory requirements
Communicates the status of unresolved compliance matters to stakeholders
Ensures the completion of review/audit of daily reports including, but not limited to final reports, protocols, and nonconforming event reports
Oversees controlled Quality documents
Identifies areas for improvement to policies and processes, assesses effectiveness of current policies and processes, and recommends changes
Provides professional and objective feedback to authors, study directors, technicians, and supervisors on quality and regulatory matters
Drafts, revises, and approves SOPs
Manages OOS and deviation events including but not limited to CAPA response reports, client notification, including tracking and reporting of OOS and deviations
Manages customer complaints including but not limited to investigating and communicating CAPAs to effected parties
Conducts and/or supports internal audits, client audits, and regulatory audits including, but not limited to coordinating audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up
Establishes and maintains Quality agreements with clients and suppliers
Supports education and training on the business on compliance awareness developing and providing quality training, including, but not limited to, GMP orientation, ongoing quality training, and annual regulatory training
Conducts and/or supports Risk Assessments
Prepares, maintains, analyzes, and presents metrics related to the quality systems and for tracking regulatory compliance of operations
Builds collaborative team environment within the department and amongst other company departments
Leads projects and implements quality initiatives in line with department and organizational goals
Completes and reports on assignments within the agreed upon timeframe
Acts as a back up to Quality Lead on an as needed basis
Trains and mentors department personnel
Supervises departmental personnel including but not limited to scheduling, time off approvals, ensuring training requirements have been met, staff development, succession planning, and performance management
Remains current in the field by review of relevant regulatory and compliance literature and attendance at appropriate seminars and conferences.
Additional duties as assigned

Additional Accountabilities and Responsibilities:

Works independently and proactively
Ability to adhere to a standard timeline and resolve issues in a timely manner
Proactively communicates progress and furthers understanding amongst colleagues and supervisors
Meets testing timelines in a reliable and efficient manner
Problem solving and conflict resolution skills in a cross functional setting
Ability to drive and meet project timelines individually and by coordinating the work of others
Updates training materials and trains others as appropriate
Subject matter expert in respective field
May serve as a delegated backup for senior staff when requested
Possesses working knowledge of regulatory environment and industry standards
Coordinates test record review

Requirements:

Bachelor’s degree from an accredited college/university in microbiology, biology, or a relevant field
5+ years' experience in the biotechnology industry with increasing scientific and leadership responsibilities
Ability to handle multiple tasks and projects under deadline pressure
Able to adapt quickly to change
Strong organizational and time management skills
Highly analytical with strong attention to detail
Excellent verbal and written communication skills
A results-oriented team player
Proficient with Microsoft Office Suite or related software

Physical Requirements:

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

Pay Rate:

The base compensation range for this role is $75,000-$95,000. 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.

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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.