Clinical Production Specialist at CATALENT CTS SINGAPORE PRIVATE LIMITED

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Feb, 26

Salary

0.0

Posted On

16 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Applications, GMP Compliance, Packaging Operations, Labeling, Data Entry, Production Monitoring, Safety Regulations, Team Supervision, Manual Assembly, Automated Packaging, Quality Assurance, Inventory Management, Cold Environment Work, Microsoft Word, JD Edwards, cGMP Knowledge

Industry

Pharmaceutical Manufacturing

Description

Clinical Production Specialist Position Summary: 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. This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia, PA is hiring a Clinical Production Specialist. The Clinical Production Specialist is responsible for the overall execution, training, monitoring and supervising clinical production staff within a specific clinical packaging batch record operation. This position requires a general knowledge of clinical applications regarding randomization schedules, open label, blind labeling, study collection and treatment groups. This is a full-time role position: Monday – Friday, 1st shift, 7:45am-4:15pm. Please Note: Occasional weekend work is required. 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 Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations in the specific production batch record assigned Oversees specific batch record operations assigned to which includes both primary and secondary production rooms equipped with various pharmaceutical packaging equipment including but not limited to: automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing Responsible for production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes and ampoules Responsible for insuring correct placement of multiple look-alike product combinations in blister units, cards and bottles Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies for specific assigned production room operation Responsible for entering data accurately in batch records and logbooks Must review completed manufacturing and packaging batch records in a timely manner All other duties as assigned The Candidate High School Diploma or General Education Diploma is required, Associate degree or some college courses taken preferred At least one year of Clinical, contract or production experience required Clinical Trial Manufacturing and Packaging experience preferred Computer literate (Microsoft Word) is required JD Edwards experience or similar ERP systems preferred Working knowledge of relevant cGMPs, DEA and OSHA rules and regulations is required Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-25 pounds Willingness to work overtime, frequently in cold environments, and track, monitor and maintain production rates, labor hours and downtime. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories 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 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. 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.

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Responsibilities

The Clinical Production Specialist is responsible for executing, training, monitoring, and supervising clinical production staff within specific clinical packaging operations. This includes ensuring compliance with GMPs, SOPs, and relevant regulations while overseeing packaging functions.