Manufacturing Manager, Plasmid DNA

Asahi Kasei•The Woodlands, TX

14d•$110,000 - $130,000•Onsite

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

Experience with new facility or laboratory start-up, equipment commissioning, qualification, and operational readiness preferred.
Proven client-facing experience strongly preferred.

Responsibilities

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.
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.