Greenville, North Carolina, United States
Onsite
Job Title: Senior Development Scientist
City: Greenville
State: NC
JOB DESCRIPTION:
Design, lead, and execute formulation and process development for early and late-stage pharmaceutical products, act as the primary client liaison for development and clinical manufacturing activities.
Design, coordinate, and execute product development and technology transfer activities, including material characterization, excipient selection, prototype formulation, equipment selection, preparation of batch records and protocols, QbD implementation, and registration batch execution.
Author essential documentation including batch records, protocols, development reports, risk assessments, and campaign summaries, and other technical documents that support product development history and CMC regulatory documents on behalf of our clients.
Ensure that all formulation and development work is accurate, precise, properly documented and, when appropriate, performed within GXP guidelines and in accordance with oral solid dosage form processes.
Manage project logistics, collaborate with suppliers, vendors, planners, and buyers to maintain sufficient inventory of raw materials.
Partner with cross-functional teams—including analytical scientists, project managers, quality assurance, and commercial operations—to ensure timely and appropriate formulation and process development.
Collaborate with quality and analytical teams to conduct thorough investigations including root cause analysis of quality events, impact assessments related to product quality events, and develop effective corrective and preventive actions (CAPAs).
Train manufacturing operators on procedures and critical process parameters (CPPs), troubleshoot scale-up challenges, and support deviations, investigations, change orders, and CAPAs throughout product development stages. Perform risk assessments and determine QTPP/CQA, solve formulation and process problems related to excipient incompatibilities, and provide recommendations to clients for optimizing dosage form and manufacturing process (e.g., compression, encapsulation, granulation, and coating).
EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Master’s degree in Pharmaceutical Science and 4 years of experience in job offered or 4 years of experience in the Related Occupation.
RELATED OCCUPATION:
Scientist or any other job title performing the following job duties:
Drive new formulation development projects for early and late stage development projects. Perform tech transfer activities and scalability studies (product compatibility study, bulk hold study, equipment selection, preparation of batch record, QBD implementation).
Draft and review protocol, batch records, product development reports, summary reports, failure mode and effect analysis and tech transfer documents. Lead multiple normal paced and rush projects with minimal supervision ensure all technical aspects are accurate, precise, properly documented, reviewed and planned to meet timelines and milestones.
Ensure material and resources planning with collaboration with internal supply chain team and external vendors ensuring sufficient inventory of raw materials for project.
Collaborate with multi-disciplinary teams (Project Managers, Analytical Scientist, Quality Assurance and Manufacturing) and compile experimental and analytical results, perform data interpretation, summarize conclusions, recommend subsequent steps and provide scientific presentations to internal and external teams.
Participate in troubleshooting and problem-solving initiatives for formulations, equipment and process for assigned projects including FMEA, root cause analysis, CAPA's, investigations and deviation.
Provide on floor support and training to manufacturing operators on CPPs, ensure smooth tech transfer and successful production run. Participate in troubleshooting and problem-solving initiatives for formulations, equipment and process for assigned projects.
Perform risk assessment on incoming project assessing Quality target product profile (QTPP), evaluating critical process parameters (CPPs) and its impact on (critical quality attribute (CQAs).
JOB TIME: Full Time
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.
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