Supervisor, Manufacturing Fill/Finish
(2nd Shift)
Catalent Pharma Solutions is looking to hire a Supervisor, Manufacturing Fill/Finish (2nd Shift) to support our Gene Therapy Team in Harmans, MD
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) . The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
The Supervisor Fill/Finish is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II & commercial GMP manufacturing.
The Supervisor is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!
This is a full-time position and is 100% on-site. The schedule is Monday - Friday 2:00PM - 10:30PM.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role
Produce clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations.
Point person on shift to assign/distribute the work and coordinate emergency situations. Responsible for shift schedule and summarizing shift progress at the end of the shift
Ensure documentation (batch records and SOPs) are accurate and updated as required.
This role is responsible for the accurate, safe, environmentally responsible, and quality compliant operations of the manufacturing process.
Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuously improvement.
Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions).
Lead and mentor staff. Write performance reviews and annual goals, hold one-on-ones.
Effectively communicate results of departmental work through team discussions and documentation.
Ensure cGMP compliance and all its related elements in documentation, reports and records.
Initiate non-conformances when identified and complete investigations to support on-time closure of deviation.
Understand and review current regulations, industry guidance, and other applicable professional documentation.
Other duties as assigned.
The Candidate
Master's or bachelor's degree in engineering or science discipline and a minimum of 5+ years of experience in biopharmaceutical based GMP manufacturing operations, related technical field, or equivalent industry experience. (Some or all this experience should be in fill/finish processing) OR
Associate's degree or HS Diploma with 8+ years' experience in biopharmaceutical based GMP manufacturing operations, related technical field, or equivalent industry experience. (Some or all this experience should be in fill/finish processing)
Experience with GMP fill finish operations and sound understanding of the drug development process required. Knowledge and understanding and knowledge of all fill finish operations including aseptic hand filling and automated filling of liquid vials preferred.
Minimum of 2 years of demonstrated leadership experience required.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC, MC and other manufacturing groups) to maintain internal and project schedules.
Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional manufacturing associates.
Ability to motivate and mentor peers, staff, and foster a culture of continuous improvement and operational excellence.
Excellent oral and written communication skills
Onsite work is required. No option for remote or hybrid work.
The anticipated salary range for this position in Maryland is $93,280 to $128,260 plus shift differential 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
Defined career path and annual performance review and feedback process
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of paid time off annually + 8 paid holidays
Competitive salary with yearly bonus potential
Community engagement and green initiatives
Generous 401K match and Paid Time Off accrual
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
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) .
