Sr. Manager, Manufacturing Operations - Plasmids
About The Position
The Sr. Manager, Manufacturing Operations – Plasmids leads safe, compliant, and efficient plasmid DNA manufacturing at Catalent’s on-site gene therapy campus in Harmans, Maryland. The role leads manufacturing associates and supervisors and owns mid-term and day-to-day production performance across the plasmid value stream, including fermentation, harvest and lysis, purification, buffer and media preparation, filtration, and bulk fill/finish as applicable. It is accountable for campaign and batch objectives and for meeting safety, quality, delivery, and cost targets while complying with GMP requirements, internal standards, and client and regulatory expectations. As the plasmid operation ramps through startup, technology transfers, and routine GMP manufacturing, this hands-on, floor-focused leader establishes a culture of right-first-time execution, equipment reliability, and continuous improvement. The role partners with MS&T, Quality, Supply Chain, Engineering and Facilities, and Project Management to support manufacturing readiness, schedule adherence, investigations, and CAPAs. It routinely interfaces with clients and auditors and reports directly to the Senior Director – Manufacturing Operations. The schedule is Monday through Friday, 8 a.m. to 5 p.m., and the position is 100% on-site. Flexibility to support off-shift coverage, on-call escalation, and periodic weekend work is also required.
Requirements
- Master’s degree in a scientific, engineering, or biotechnology field and 6+ years of GMP manufacturing operations experience in biologics or biopharmaceuticals (such as plasmids, vaccines, microbial fermentation, or related); alternatively, a bachelor’s degree in one of these fields and 8–10+ years of such experience.
- At least 5 years of progressive leadership and direct management experience.
- Strong understanding of plasmid DNA manufacturing processes, including microbial fermentation, harvest/lysis, chromatographic purification, UF/DF, and filtration, and controls to prevent contamination, mix-ups, and quality risks.
- Familiarity with electronic manufacturing and quality systems, such as MES/eBR, LIMS, deviation/CAPA systems, and CMMS, and the ability to generate, analyze, and interpret production and quality metrics.
- Strong analytical, troubleshooting, and decision-making skills under pressure, with demonstrated root-cause analysis and continuous-improvement experience.
- Effective communication across technical and non-technical audiences and ability to work independently and collaboratively in cross-functional teams with minimal supervision.
- Ability to deliver results in a fast-paced GMP environment and flexibility to support off-shift coverage, on-call escalation, and periodic weekend work.
- Ability to coach, mentor, and develop employees to support performance and engagement.
Nice To Haves
- Experience leading supervisors and/or shift teams.
- Demonstrable leadership experience at Catalent, including participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, or GROW; this may be considered in place of external experience.
- Ability to rapidly learn new processes supporting new clients.
Responsibilities
- Foster a quality culture emphasizing data integrity, right-first-time execution, safety, and continuous improvement across plasmid DNA manufacturing.
- Own day-to-day plasmid DNA manufacturing execution and ensure adherence to approved batch records, SOPs, aseptic and non-aseptic controls, and documentation requirements.
- Monitor KPIs and drive production performance against schedule, yield, and cycle-time targets by identifying gaps and implementing corrective actions.
- Ensure shift-level manufacturing readiness, including materials availability, equipment status, room readiness, line clearance, personnel training compliance, and documentation preparedness.
- Provide visible, hands-on floor leadership and reinforce safe work practices, contamination control, and GMP documentation standards.
- Lead, coach, and develop the manufacturing team through onboarding, feedback, engagement, accountability, shift coverage, and escalation models.
- Ensure personnel qualification and training compliance with Quality and Training, including on-the-job training, proficiency sign-offs, and curriculum completion.
- Own and support investigations, including deviations and nonconformances, and CAPAs; ensure timely root-cause analysis, effective corrective action, and cross-functional alignment.
- Partner with Engineering and Facilities on equipment reliability and availability, including preventive maintenance, calibration, troubleshooting, validation, and readiness for new equipment or processes.
- Collaborate with MS&T, Quality, Supply Chain, Warehouse, and Project Management to execute production plans, support technology transfers, and resolve delivery constraints.
- Ensure compliance with global GMP and regulatory requirements and support regulatory inspections and client audits.
- Drive continuous improvement and risk management through structured problem-solving, Lean/6S practices, metrics, and quality risk management.
- Support off-shift, weekend, and on-call operational needs.
- Perform other duties as assigned by management.
Benefits
- Medical, dental, vision, and 401(k) offered from the first day of employment.
- 152 hours of paid time off and 8 paid holidays.
- Annual bonus, when eligible.
- Potential for career growth within an expanding team.
- Defined career path and annual performance review and feedback process.
- Cross-functional exposure to other areas of the organization.
- Opportunity to work on continuous improvement processes.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
