Position Summary:Catalent Pharma Solutions in Somerset, NJ is hiring a Principal Scientist of Hot Melt Extrusion for the Formulation team. This position contributes significantly to the successful timely development of new pharmaceutical products utilizing oral solid formulation drug delivery systems and hot melt extrusion technology by conducting required formulation and process development activities. The Principal Scientist will apply technical, functional, business, and/or industry knowledge to design experiments/projects; and provide scientific consultation to the department/ discipline/group. This person will actively contribute to the strategic direction of the department/ group by recommending expansion or curtailment of investigations based on experimental results or scientific information.This is a full-time salaried position: Monday – Friday, 8AM-5PMCatalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent in Somerset, NJ is home to oral solid dose manufacturing operations as part of the Oral and Specialty Delivery (OSD) business unit. On site we have our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the Catalent Center of Excellence for handling Highly Potent Active Pharmaceutical Ingredients.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
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.
All other duties as assigned;
The Candidate
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;
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 + 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
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.Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.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 [email protected] . 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 [email protected] 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) .