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:
Associate Director of QC / HPLC
The QC leadership role oversees QC Operations. This role provides leadership across all QC functions with focus HPLC & Capillary and optimization of QC laboratory IT systems.
Partnering closely with the Senior Director of Quality Control, this position help support the establishing efficient, compliant, and high-performing laboratory operations with a strong quality and safety culture. This role ensures effective implementation of the Bionova Quality Management System, supports delivery of a state-of-the-art, automated laboratory in collaboration with Engineering, and works cross-functionally and with clients to ensure timely, reliable, and regulatory-compliant analytical results.
This role requires deep expertise in Quality Control GMP operations and quality systems, along with demonstrated leadership capability and the ability to effectively influence teams and stakeholders across organizational and global environments.
_Position Responsibilities:_
- Serve as an HPLC subject matter expert and drive improvement of HPLC workflows and our Empower based CDS.
- Lead, coach, and develop a team of analysts and junior managers to ensure high technical and performance standards.
- Establish and maintain compliant laboratory operations aligned with Bionova quality standards and regulatory requirements, including the definition and monitoring of key performance indicators.
- Implement Lean laboratory practices and drive continuous improvement to enhance efficiency and performance.
- Review and interpret analytical data to identify trends, assess risk, and initiate appropriate corrective actions.
- Lead investigations for deviations, including OOS, OOT, OOR, and OOE, performing root cause analysis and defining corrective and preventive actions.
- Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein
- Author and maintain analytical methods, validation and qualification documentation, and relevant laboratory procedures.
- Support cross-functional QC activities by providing cross-trained resources to address urgent analytical needs.
- Act as a subject matter expert during client audits and regulatory inspections, representing QC analytical and operational processes.
_Working Conditions:_
This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
_Qualifications:_
- Bachelor of Science degree or equivalent in a scientific field
- Minimum of 6 years of experience in analytical or quality control environments. Minimum of 3 years of GMP Quality Control Laboratory.
- Strong working knowledge of HPLC and CE analytics with expertise in method development and GMP validation.
- Experience in designing CDS workflows (data review, audit trails, design of workflows, custom fields…)
- Expertise in data analysis, trend analysis, and statistical methods.
- Excellent written and verbal communication skills to effectively document findings and present technical information.
- Working knowledge of GMP regulations and guidance (21 CFR, ICH, Eudralex etc.)
- Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events
- Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, or equivalent systems)
- Effective interpersonal and communication skills. Communication at all management levels and all staff is required.
