Manufacturing Manager, Plasmid DNA

Bionova Scientific LLC; United States; On-site; USD 110,000 - 130,000; Full time

Job summary

Bionova Scientific LLC, part of the Asahi Kasei Group, seeks a Manufacturing Manager to lead end-to-end plasmid DNA manufacturing operations, including upstream, downstream, and support activities. You will ensure GMP-compliant, on-time execution of programs and partner across departments to drive technology transfer and manufacturing readiness.

This hands-on leadership role requires deep technical knowledge of plasmid DNA manufacturing and strong people management, scheduling, and day-to-day

Qualifications

• BS or MS in Biology, Chemical Engineering, Microbiology, Biochemistry, Biotechnology, or related scientific/engineering discipline.
• Demonstrated hands-on GMP manufacturing experience.
• Minimum 10+ years of relevant industry experience (BS) or 7+ years (MS).
• Strong understanding of end-to-end microbial/plasmid DNA manufacturing and related unit operations.
• Experience leading cross-functional teams and managing multiple client programs.

Responsibilities

• Lead plasmid DNA manufacturing operations (USP, DSP, etc.) and ensure GMP compliance.
• Provide day-to-day leadership and staffing to meet schedules and client commitments.
• Oversee deviations, CAPAs, change controls, investigations, and root-cause analysis.
• Collaborate with QA, QC, PD, MSAT, and other functions to ensure readiness and risk mitigation.
• Report manufacturing readiness and performance metrics to leadership.

Skills

Leadership

GMP knowledge

Biologics manufacturing

Cross-functional collaboration

Problem solving

Project management

Education

BS in Biology

MS in Biotechnology / related field

Job description

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 escalates.

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 programs and manufacturing priorities.
• Strong problem‑solving skills with the ability to identify operational risks and implement practical solutions.
• Proven client‑facing experience strongly preferred.
• Strong attention to detail and commitment to quality and compliance.
• Effective written, verbal, and interpersonal communication skills.
• Demonstrated ability to operate independently while collaborating effectively across functions.

Compensation

The base compensation range for this role is $110,000-$130,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Company Culture and Benefits

Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us.

As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career.

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.

About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care.

In North America, Asahi Kasei currently has over 23 business units and 10,000 employees. Our People Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions.