Sr. Manager, Manufacturing Operations - Plasmids

Catalent•Harmans, MD

2d•Onsite

About The Position

Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products. The Sr. Manager, Manufacturing Operations – Plasmids is responsible for the safe, compliant, and efficient execution of plasmid DNA (pDNA) manufacturing operations, leading a team of manufacturing associates and supervisors to deliver campaign and batch objectives. This role owns mid-term and day-to-day production performance across the plasmid value stream (e.g., fermentation, harvest/lysis, purification, buffer/media prep, filtration, and bulk fill/finish steps as applicable) and ensures operations meet GMP requirements, internal standards, and client/regulatory expectations. As the plasmid operation ramps (startup, tech transfers, and routine GMP manufacturing), this leader establishes a culture of right-first-time execution, high equipment reliability, and continuous improvement. The role partners closely with MS&T, Quality, Supply Chain, Engineering/Facilities, and Project Management to ensure manufacturing readiness, schedule adherence, and robust investigation and CAPA execution. This is a hands-on, floor-focused leadership role requiring deep technical understanding of plasmid manufacturing, strong people leadership, and the ability to drive performance through data and standard work. The position interfaces routinely with clients and auditors and is accountable for meeting safety, quality, delivery, and cost targets for the plasmid manufacturing area.

Requirements

Master’s degree in a scientific, engineering, or biotechnology field with 6+ years’ experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related) OR Bachelor’s degree in a scientific, engineering, or biotechnology field with 8–10+ years’ experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related).
5+ years of progressive leadership and direct management experience.
Experience leading supervisors and/or shift teams preferred.
Familiarity with electronic manufacturing and quality systems (e.g., MES/eBR, LIMS, deviation/CAPA systems, CMMS) with the ability to generate, analyze, and interpret production and quality metrics.
Strong analytical, troubleshooting, and decision‑making skills under pressure, with demonstrated experience in root‑cause analysis and continuous improvement initiatives.
Strong understanding of plasmid DNA manufacturing processes (e.g., microbial fermentation, harvest/lysis, chromatographic purification, UF/DF, filtration) and controls to prevent contamination, mix‑ups, and quality risks; ability to rapidly learn new processes supporting new clients.
Effective communicator across technical and non‑technical audiences, able to work both independently and collaboratively in cross‑functional team environments with minimal supervision.
Proven ability to deliver results in a fast‑paced GMP environment, including flexibility to support off‑shift coverage, on‑call escalation, periodic weekend work, and the ability to coach, mentor, and develop employees to support performance and engagement.

Nice To Haves

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Responsibilities

Foster a strong Quality Culture emphasizing data integrity, right‑first‑time execution, safety, and continuous improvement across plasmid DNA manufacturing operations.
Own day‑to‑day execution of plasmid DNA manufacturing activities, ensuring adherence to approved batch records, SOPs, aseptic/non‑aseptic controls, and documentation requirements.
Drive production performance to meet schedule, yield, and cycle‑time targets by monitoring KPIs, identifying gaps, and implementing corrective actions.
Ensure manufacturing readiness each shift, including materials availability, equipment status, room readiness, line clearance, personnel training compliance, and documentation preparedness.
Provide visible, hands‑on leadership on the manufacturing floor, reinforcing safe work practices, contamination control behaviors, and strong GMP documentation standards.
Lead, coach, and develop a high‑performing manufacturing team through onboarding, performance feedback, engagement, accountability, and effective shift coverage and escalation models.
Ensure personnel qualification and training compliance in partnership with Quality and Training, supporting on‑the‑job training, proficiency sign‑offs, and curriculum completion.
Own and support manufacturing investigations (deviations, nonconformances) and CAPAs, ensuring timely root‑cause analysis, effective corrective actions, and cross‑functional alignment.
Partner with Engineering and Facilities to maintain equipment reliability and availability, supporting PMs, calibrations, troubleshooting, validation activities, and operational readiness for new equipment or processes.
Collaborate cross‑functionally with MS&T, Quality, Supply Chain, Warehouse, and Project Management to execute production plans, support technology transfer, and resolve constraints impacting delivery.
Ensure compliance with global GMP and regulatory requirements (FDA 21 CFR 210/211, ICH Q‑series, EU Annex 2, USP <1040>), and support regulatory inspections and client audits.
Drive continuous improvement and risk management using structured problem‑solving, Lean/6S practices, metrics, and quality risk management (ICH Q9), while maintaining flexibility to support off‑shift, weekend, or on‑call operational needs.
Other duties as assigned by management.