Manufacturing Manager, Plasmid DNA

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:

The Manufacturing Manager is responsible for leading end-to-end plasmid DNA manufacturing operations , including upstream processing (USP), downstream processing (DSP), and manufacturing support activities. This role is accountable for safe, compliant, on-time, and efficient execution of client manufacturing programs in accordance with approved batch records, procedures, quality requirements, and project commitments.

The Manufacturing Manager will build and lead the manufacturing team, establish operational readiness, and partner closely with Process Development, MSAT, Quality Assurance, Quality Control, Program Management, Supply Chain, Facilities/Engineering, and clients to ensure successful technology transfer and manufacturing execution.

This is a hands-on leadership position requiring both strong technical understanding of plasmid DNA manufacturing and the ability to manage people, priorities, schedules, and day-to-day GMP operations.

Location: The Woodlands, TX

Essential Duties and Responsibilities:

GMP Facility & Utility Ownership

• •Lead all plasmid DNA manufacturing activities, including USP, harvest, clarification, DSP, formulation, filtration, and associated manufacturing support activities.
• •Provide day-to-day leadership and oversight of manufacturing operations to ensure execution according to approved batch records, SOPs, client requirements, and established schedules.
• •Recruit, train, develop, and lead manufacturing scientists and associates; establish clear responsibilities, performance expectations, and development plans.
• •Maintain appropriate staffing and resource plans to support manufacturing schedules and client commitments.
• •Partner with Process Development and MSAT to facilitate effective technology transfer, scale-up, process implementation, and manufacturing readiness.
• •Ensure personnel, equipment, materials, documentation, and facility readiness prior to manufacturing campaigns.
• •Ensure manufacturing activities comply with applicable GMP requirements, regulatory expectations, company Quality Systems, and industry best practices.
• •Provide manufacturing leadership for deviations, investigations, CAPAs, change controls, and operational troubleshooting.
• •Support root-cause investigations through process knowledge, equipment troubleshooting, data review, and testing as appropriate.
• •Drive timely initiation, investigation, and closure of manufacturing-related deviations and change controls.
• •Review and/or author manufacturing documentation, including batch records, SOPs, work instructions, equipment procedures, and manufacturing forms.
• •Partner with Supply Chain and Program Management to develop and maintain Bills of Materials and ensure timely availability of raw materials and consumables.
• •Collaborate with QA, QC, PD, MSAT, Facilities/Engineering, Supply Chain, and Program Management to identify and resolve risks that could impact manufacturing execution or client timelines.
• •Participate directly in client meetings, facility tours, technical discussions, manufacturing readiness reviews, and program updates.
• •Support equipment selection, commissioning, qualification, and implementation of new manufacturing technologies.
• •Maintain manufacturing areas and equipment in a state of operational and inspection readiness.
• •Establish and monitor manufacturing performance indicators, including schedule adherence, right-first-time execution, deviation performance, productivity, and operational readiness.
• •Identify opportunities to improve manufacturing efficiency, reliability, capacity, and cost while maintaining product quality and GMP compliance.
• •Promote a culture of safety, quality, accountability, collaboration, and continuous improvement within the Manufacturing organization.
• •Maintain awareness of industry trends, emerging technologies, and best practices relevant to plasmid DNA and microbial manufacturing.

Strategic Leadership & Reporting

• •Provides concise, fact-based reporting to the leadership team on manufacturing readiness, compliance risks, and performance metrics.
• •Tracks expenditures, and identifies opportunities for cost control while safeguarding compliance.

Leadership Expectations

• •Operates with independence and minimal supervision, driving structured processes and ensuring compliance across all responsibilities.
• •Provides leadership in site culture by reinforcing accountability, discipline, and readiness.
• •Functions as a team player and effective cross-functional partner, working seamlessly with F&E, Quality, PD, Validation, and Materials Management.
• •Anticipates issues, develops risk-mitigation plans, and communicates clearly to leadership before issues escalate.

Expected Qualities:

• •Independent performance Operates with minimal oversight while ensuring compliance, structure, and consistent execution
• •Solution-oriented Comes with answers, not just problems
• •Resourceful Can navigate constraints, prioritize, and mobilize support
• •Anticipate potential roadblocks early, develop mitigation strategies , and communicate them proactively to stakeholders.

Working Conditions:

• •This position requires work in manufacturing, laboratory, and office environments.
• •The role requires walking, standing, stooping, kneeling, and crouching.
• •The employee must occasionally lift and/or move up to 40 pounds independently.
• •Flexibility to support manufacturing operations outside normal business hours may be required based on production schedules.

Qualifications:

• •BS or MS in Biology, Chemical Engineering, Microbiology, Biochemistry, Biotechnology, or related scientific/engineering discipline.
• •Minimum 10+ years of relevant industry experience with a BS or 7+ years with an MS, preferably within GMP biologics, plasmid DNA, microbial fermentation, or related manufacturing.
• •Minimum 3–5 years of people leadership experience, including direct people management or significant leadership responsibility within a matrix organization.
• •Demonstrated hands-on experience executing and/or leading GMP manufacturing processes.
• •Strong understanding of end-to-end microbial/plasmid DNA manufacturing, including fermentation, harvest/centrifugation, TFF, chromatography, filtration, and single-use technologies.
• •Experience with GMP manufacturing documentation, batch records, deviations, investigations, CAPAs, and change controls.
• •Experience supporting technology transfer, scale-up, and implementation of processes into manufacturing.
• •Experience with new facility or laboratory start-up, equipment commissioning, qualification, and operational readiness preferred.
• •Demonstrated ability to lead cross-functional teams and manage multiple client p