Principal Formulation Development Specialist
7 days ago
Catalent Inc is seeking a highly skilled Senior Formulation Scientist to join our team in the development and manufacturing of new treatments for patients worldwide. As a key member of our Formulation team, you will contribute significantly to the successful timely development of new pharmaceutical products utilizing oral solid formulation drug delivery systems and hot melt extrusion technology.
Key Responsibilities- Apply Hot Melt Extrusion (HME) technology, for solubility enhancement including development of amorphous solid dispersions based oral dosage forms development
- Apply scientific knowledge and hands on skills in solid oral dosage form development approaches from preclinical to clinical formulations development, process development, and scaleup
- Responsible for technology transfer formulations and processes, and provide technical support to the pilot plant by establishing the requirements for pilot plant batch manufacturing and overseeing the execution of such studies
- Employ preformulation techniques including application of DSC, TGA, XRPD, SEM, Hot stage microscopy, and interpretation of data
- Maintain high quality GDP documentation in accordance with applicable regulatory guidance and Site SOPs and provide input into SOPs and site policies
- Understand and interpret technical information and apply to problem solving on extremely complex issues
- Author documents (including but not limited to, technical specifications, project risk assessments, development reports, development reports) and data provided to the client
- Routinely applies project management skills for multiple and concurrent projects of high complexity
- Develop strategies and tactics to formulation development and lifecycle support to meet regulatory milestones
- Prioritize and suggest alternatives or contingencies to achieve advanced technical solutions and efficiently utilize resource
- Interprets data that should include statistical analysis, design of experiments, and other plotting and graphing tools useful in presenting and explaining development data.
- Bachelors degree in Chemistry, Pharmaceutical Sciences, or similar is required; Masters degree or PhD is preferred
- 12 or more years of experience in formulation development of oral solid dosage required with a Bachelors degree, 10 or more years of experience is required with a Masters degree, and 5 or more years of experience is required with a PhD
- 3 years of hands-on experience with Hot Melt Extrusion or amorphous solid dispersion development using relevant techniques is required
- Technical skill in multiple formulation techniques, pharmaceutical manufacturing processes, and development strategies is required
- Experience in Twin screw melt granulation, Twin Screw wet granulation, process analytical technologies, and/or preformulation techniques is preferred
- Hands on experience with DSC, TGA, XRPD Hot stage microscopy is preferred
- Experience in the application of scientific principles and techniques (such as organic chemistry, polymer chemistry, solid-state chemistry, pharmaceutics) and common pharmaceutical processing techniques (tablets, capsules, modified-release dosage forms) is required
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
- 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 + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match
- Company match on donations to organizations
- Medical, dental and vision benefits effective day one of employment
- 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
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Senior Formulation Scientist
7 days ago
Somerset, New Jersey, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Senior Formulation Scientist to join our team in Somerset, NJ. As a key member of our Formulation team, you will be responsible for the development and implementation of hot melt extrusion technology for the creation of amorphous solid dispersions.Key ResponsibilitiesApply hot melt extrusion technology to...
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Pharmaceutical Development Specialist
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