What are the responsibilities and job description for the Manufacturing Associate Scientist position at Asahi Kasei America Inc?
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 :
The Manufacturing Associate Scientist plays a key role in supporting the development, enhancement, and commercialization of new and existing products as well as assisting in the implementation of ISO 9001 / 17034 and other relevant standards or regulatory requirements. They support analytical and product development efforts by assisting in the execution of new products and testing services, which includes communication with clients and key stakeholders to ensure alignment and successful outcomes. This position performs laboratory experiments under the guidance of senior staff, including drafting and executing protocols, analyzing results, and identifying potential issues. They recommend and implement solutions, contribute to the development of innovative techniques, and collaborate with cross-functional teams to ensure project goals are met.
Key Accountabilities and Responsibilities :
- Supports all activities associated with the development, enhancement, and execution of new and existing products and testing services
- Manages laboratory experiments under the guidance of senior staff including, but not limited to, the preparation and execution of protocols, authoring reports and presentations, and assisting in the drafting of manuscripts
- Assists in the management of manufacturing and scale-up of commercial products, ensuring that they meet quality control standards and regulatory requirements
- Assists in the setting up and management of reliable supply chain to handle raw materials, production, distribution, and post-sale support.
- Supports the Quality department in implementing and maintaining ISO 9001 (Quality Management System) and ISO 17034 (General Requirements for the Competence of Reference Material Producers) and any other relevant standard or regulatory requirements.
- Implements daily operations of assigned projects including SOP development as appropriate
- Works closely with Quality to ensure all efforts are in alignment with regulatory requirements as well as BTL policies and procedures
- Reviews research findings and data trends, offering practical insights and suggesting ways to improve tools, methods, or experiments to make them more accurate and effective
- Coordinates and manages activity and project resource schedules
- Works independently on collection of data and analyzes research results
- May co-author publications and may co-present results at meetings or conferences
- Guides and mentors staff
- Responsible for maintaining detailed laboratory records of all activities
- Since they function as part of a collaborative and dynamic team, Associate Scientists must demonstrate strong interpersonal skills
- Additional duties as assigned
Additional Accountabilities and Responsibilities
Requirements :
Physical Requirements :
Pay Rate :
LI-MG1
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 : $60,000 - $70,000
