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:

Company Summary: 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 challenges.

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.

Position Summary: We are searching for a driven, resourceful, and solution-oriented leader for the Director/Senior Director of Process Development, Plasmid DNA & Operational Excellence role in the Houston/Woodlands, Texas area. This role will be responsible for leading process development, MSAT, and operational excellence initiatives for manufacturing, ensuring technical innovation, cross-functional alignment, and execution against aggressive timelines. The ideal candidate will not only bring deep technical and regulatory expertise in plasmid DNA development but will also consistently bring answers, not roadblocks, proactively identifying potential risks, presenting viable solutions, and leveraging resources to maintain momentum. They will be adept at anticipating challenges before they impact timelines, aligning stakeholders with clear data-driven recommendations, and driving accountability across teams. This position demands a leader who can balance strategic vision with hands-on problem-solving, ensuring that operational and technical goals are met with speed, compliance, and efficiency. The success of our plasmid DNA platform expansion and operational readiness will depend heavily on this individual's ability to deliver results, foster a culture of solution-based thinking, and continually enhance processes for long-term success. Essential Duties and Responsibilities: Lead Operational Excellence initiatives for the B4 site, focusing on efficiency, quality, and continuous improvement across PD, MSAT, and Manufacturing. Establish KPI-driven performance management systems to monitor technical, operational, and financial performance. Foster a culture of accountability, collaboration, and data-driven decision-making. Serve as the primary escalation point for technical and operational challenges in PD, MSAT, and manufacturing operational excellence; bring forward viable solutions with clear risk/benefit analysis. Anticipate potential roadblocks early, develop mitigation strategies, and communicate them proactively to stakeholders. Leverage internal and external resources to solve problems without disrupting timelines. Implement Lean/Six Sigma methodologies and drive root-cause problem-solving for technical and operational challenges. Translate technical challenges into clear, actionable recommendations for executives, clients, and cross-functional teams. Foster an environment where the team comes forward with solutions and data rather than obstacles and opinions. Hold teams accountable for solution-based thinking, ensuring every problem presented is accompanied by at least one proposed path forward. Lead development and optimization of microbial fermentation and purification processes for plasmid DNA at research, high-quality, and GMP scales. Develop and execute scale-up strategies from laboratory to commercial manufacturing, ensuring scalability, robustness, and cost-effectiveness. Oversee MSAT activities, including process validation, process monitoring, and manufacturing support readiness. Provide leadership during engineering runs and process troubleshooting in collaboration with Manufacturing. Align MSAT activities with regulatory expectations and client deliverables. Partner with Manufacturing leadership to identify and implement efficiency, quality, and cost-optimization initiatives. Provide input on manufacturing workflows, KPI monitoring, and resource utilization without direct responsibility for daily operational management. Collaborate with Manufacturing to integrate continuous improvement frameworks into production operations. Ensure all PD and MSAT activities meet applicable cGMP, ICH, FDA, EMA, and other relevant guidelines. Oversee documentation for regulatory submissions, comparability packages, and process validation reports. Build, lead, and mentor high-performing teams across PD and MSAT functions. Develop multi-year capability roadmaps and resource plans for the site. Manage budgets for operations, capital projects, personnel, and materials. Drive adoption of digital and AI solutions for process monitoring, documentation, and operational tracking. Collaborate with QA, QC, Program Management, Supply Chain, and Business Development. Maintain strong client relationships through transparent communication, milestone tracking, and delivery excellence. Identify new business opportunities in alignment with corporate growth strategies. Expectations from the Role: Solution-oriented : Thinks and comes with answers, not just problems Resourceful : Can navigate constraints, prioritize, and mobilize support Clear in ownership : Knows their scope but also sees the bigger picture Working Conditions: This position is required to work in a lab/office setting. May require frequent standing, sitting, pushing, pulling and walking. Ability to lift up to 20 lbs and work on feet for extended periods. Occasional travel for client engagement, conferences, or vendor visits. Qualifications: BS/MS in relevant life science disciplines with 15 plus years of related experience in life science disciplines. Demonstrate outstanding technical acumen, operational understanding, and GMP compliance in building and running the Manufacturing Operations Department Experience in Quality Systems with experience in leading teams in successful through development and launch in various product line in multiple regions. Excellent understanding of cGMP principles, including validation and the regulatory path for Biologic drug approval Experience in risk management and preferably experience in lean manufacturing experience. Technical/Scientific expertise in biologics and aseptic manufacturing Demonstrated Client Interaction and Project Management experience. Proven ability in managing and coaching experienced research scientists and associated projects. Strong Molecular Biology knowledge and background Relevant experience with research grade plasmid DNA production and GMP Plasmid DNA production and microbial fermentation and purification Use strong communication and teamwork skills to build strong relationships with stakeholders. Provide oversight for the maintenance/retrofit of existing plasmid manufacturing facility. Serve on company's appropriate Project Teams as the Senior Manufacturing representative for plasmids. Provide critical leadership for interactions with various agencies (e.g., regulatory agency meetings such as FDA, EMA, etc.) Champion the implementation of new technologies and systems Strong analytical, strategic thinking and troubleshooting skills. Provide leadership in the development of strategic Plasmid manufacturing plans. Authorized to legally work in the United States without visa sponsorship.

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.