Manufacturing Specialist - Fill/Finish

Catalent

3d•$105,000 - $120,000•Onsite

About The Position

Manufacturing Specialist – Fill/Finish Position Summary: Work Schedule: Monday – Friday, 8am-5pm 100% on-site 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 Manufacturing Specialist supports the day-to-day operations of the manufacturing process as a Subject Matter Expert, providing oversight and guidance to the tactical operations. Additionally, this function integrates continuous improvement and technical knowledge transfer into the larger manufacturing organization by acting as the liaison between manufacturing and the site CI and MS&T organizations. The incumbent reports into the Manufacturing Control Center and provides support for lean six sigma (LSS) problem solving, value stream management, continuous improvement assessment process, electronic systems integration, tech transfer, manufacturing training, RCA / CAPA, and quality remediations. The Manufacturing Specialist will report to Director, Manufacturing Fill/Finish.

Requirements

Master’s degree in a scientific, engineering, or biotech field with 3+ years of aseptic filling experience in a GMP environment, OR a Bachelor’s degree with 4+ years, OR an Associate’s degree/HS diploma with 5+ years in aseptic filling within GMP‑regulated manufacturing.
Knowledge of EU Annex 1, GMP’s, FDA regulations and documentation procedures required.
Previous experience operating equipment such as: peristaltic or piston pump aseptic fillers, automated packaging lines, semi-automated visual inspection stations, autoclaves, parts washers, and filter integrity testers required.
Previous experience in process deviation investigations and Previous experience authoring and/or revising technical documents required.
Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget.
Excellent communication and technical writing skills and can support and/or lead system troubleshooting efforts.
Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways.

Nice To Haves

Experience as a MES, EMS, MRP, LIMS, or LMS user and basic programming skills a plus.

Responsibilities

Provide scheduling support and operational oversight for day‑to‑day fill/finish manufacturing activities.
Track, trend, analyze, and report key performance parameters and in‑process controls.
Partner with CI, MS&T, and QA teams to apply Lean Six Sigma and value‑stream management methodologies.
Lead ongoing continuous improvement (CI) assessments within the fill/finish organization.
Represent Manufacturing in defining user requirements and implementing electronic batch records (eBRs) and integrated systems.
Provide technical leadership for fill/finish processes, ensuring strong product and process understanding to support high‑quality investigations and effective corrective actions.
Develop and deliver on‑the-job training for fill/finish associates and support individual training plan management.
Support batch record review and disposition activities to meet lot release timelines.
Lead or support root cause investigations; author deviations, CAPAs, and change controls; and contribute to quality remediation efforts.
Gather, trend, and present data for investigations and provide real‑time, on‑the-floor support for operational deviations.
Performs other duties as assigned.