Manager, Quality Control

Asahi Kasei•The Woodlands, TX

47d•Onsite

About The Position

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.

Requirements

BS, MS or PhD in Pharmaceutical Sciences, Chemistry, Biophysics or Biochemistry with 10+ years for BS, 7+ years for MS and 5+ year for PhD of relevant research and/or biotechnology industry experience.
3-5 years of people leadership or managing people in direct reporting roles or in matrix organizations.
In-depth understanding of analytical and microbial test methods and industry-standard analytical tools (HPLC/UPLC, sequencing, PCR, ELISA, microbiological assays, compendial assays, etc.).
Experience with new laboratory start-up and equipment commissioning.
Hands-on experience in running, qualifying, and validating analytical methods.
Creative thinker that can identify and efficiently improve methods to address issues and gaps.
Demonstrate ability to work independently and on cross-functional teams.
Strong attention to detail.
Effective verbal and written communication skills.

Nice To Haves

Proven client interactions and project management experience desired.

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.