Manager, Quality Control

Asahi Kasei Semiconductor, Inc.

The Woodlands, Texas

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JOB DETAILS

SKILLS

Analysis Skills, Analytical Development, Assay Methods, Best Practices, Budget Management, Business Development, Business Growth, Cell Cultures, Change Control, Cross-Functional, Customer Relations, DNA, Documentation, Environmental Monitoring, Equipment Maintenance/Repair, GMP (Good Manufacturing Practices), Healthcare, High Performance Liquid Chromatography (HPLC), Housekeeping/Cleaning, Laboratory, Manufacturing, Manufacturing/Industrial Processes, Materials Testing, Mentoring, Operational Improvement, Operational Strategy, Patient Care, People Management, Polymerase Chain Reaction (PCR), Problem Solving Skills, Procedure Implementation, Process Development, Product Safety, Production Support, Project/Program Coordination, Project/Program Management, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Regulations, Regulatory Reports, Regulatory Submissions, Resolve Customer Issues, Staff Training, Standard Operating Procedures (SOP), Talent Management, Team Lead/Manager, Technical Writing, Test Data, Testing, Time Management, Validation Plan, Writing Skills

LOCATION

The Woodlands, Texas

POSTED

2 days ago

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:

Position Summary:

The role will be responsible for leading quality control activities, staffing the functional area, and building the infrastructure to enable on-time and within budget execution and completion of future client projects. Partnering closely with cross-functional representatives and clients, this role will enable Plasmid DNA testing activities are completed per agreed upon timelines and deliverables. As a manager of the QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes.

Essential Duties and Responsibilities:

• Recruit, train, and lead a team of scientists and associates responsible for QC activities. Provide guidance, mentorship, and performance feedback.

• Ensure all testing activities adhere to applicable regulatory guidance and industry best practices.

• Compile and/or support the creation of documentation for regulatory submissions.

• Collaborate with cross-functional teams and clients, including Manufacturing, Process development, Analytical Development, Quality Assurance, Program Management, and

Business Development to ensure alignment of analytical method qualification and testing activities with overall company and client objectives.

• Prepare and present concise, sound scientific presentations of testing data to the internal and external team for decision making.

• Face-to-face interaction with clients to discuss laboratory capabilities and provide feedback.

• Author technical documents such as laboratory and assay SOPs, method transfer protocols/reports, and method qualification protocols/reports.

• Manage/perform general laboratory duties associated with equipment maintenance and good housekeeping.

• Establishment of select QC functions through implementation of GMP procedures, processes, and systems.

• Manage a team of QC analysts, mentor and train staff members based upon prior experience level.

• Oversee day-to-day operations of the department and direct reports.

• Manage/Perform QC testing to support GMP production, raw material testing, facility controls (environmental monitoring), stability studies, and standalone QC testing projects.

• Manage/author of deviations, CAPAs and change controls.

• Lead or oversee method transfer and qualification of analytical test methods (HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing and others) as required.

• Project management and coordination of various high impact internal and external projects where analytical/Micro/EM input is valued.

• Author/review/approve technical documents such as method validation and qualification protocols/reports, and regulatory filing documents per project needs.

• Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.

• Lead select QC function meetings with clients to move projects forward and/or triage issues.

• Evaluate new technologies and innovations to improve operational efficiency or expand QC capabilities.

• Interpret/review analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing.

• Represent the QC function during inspections from regulatory agencies and client audits.

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About the Company

Asahi Kasei Semiconductor, Inc.

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