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.
The Role:
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.
The Candidate:
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.
Experience as a MES, EMS, MRP, LIMS, or LMS user and basic programming skills a plus.
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.
The anticipated salary range for this position in Maryland is $105,000 to $120,000 and annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the @type and length of experience within the job, @type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why you should Join Catalent:
Potential for career growth within an expanding team.
Defined career path and annual performance review & feedback process.
Cross-functional exposure to other areas within the organization.
Medical, Dental, Vision, and 401K are all offered from day one of employment.
152 hours of PTO and 8 paid holidays.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any @type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
