Location: Greenville,NC, USA
Job Title: Development ScientistCity: GreenvilleState: NCJOB DESCRIPTION:* Design, coordinate, and execute all product development activities for oral solid dosage form including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records and scale-up* Design, coordinate and execute development experiments based on QbD principles* Design, coordinate and execute CTM activities, including pre-commercial manufacturing, formulation, data interpretation utilizing statistical software (e.g., Minitab, JMP), oral solid dosage equipment selection based on batch size and scale-up principles, generation of batch records and process evaluation/validation protocol, hold study/stability protocol* Responsible for GMP compliance in formulation and process development* Assist with planning and operating within a budget for the pharmaceutical area* Responsible for all formulation and process development of several ongoing projects including project management* Manage projects by partnering and directly communicate with consultants, internal support groups, regulatory authorities, vendors/suppliers verbally and in writing to agree on development approaches and scope of work based on analytical data* Assist manufacturing group with batch manufacture and packaging/labeling, including set-up and cleaning* Solve formulation and process problems related to excipient incompatibilities, oral solid dosage manufacturing process optimization (e.g., compression, encapsulation, granulation, and coating)* Write batch records, SOPs, IQ/OQ/PQ documents, process evaluation/validation protocol development/technical reports, and CMC sections for regulatory submissions as directed for NDA, 505b2 and IND filings* 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* Maintain competence and training documentation for relevant equipment and processes* Perform risk assessments and determine QTPP/CQA before transfer* Initiate and assist in quality investigations including GMP batch deviations, quality events, non-conformance events and customer complaintsEDUCATION AND EXPERIENCE: Requires a Bachelor's degree in Pharmaceutical Science and 3 years of experience in job offered or 3 years of experience in the Related OccupationRELATED OCCUPATION:Development Scientist or any other job title performing the following job duties:* Designing, coordinating, and executing all product development activities for oral solid dosage form including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records and scale-up* Designing, coordinating and executing development experiments based on QbD principles* Assisting with planning and operating within a budget for the pharmaceutical area* Responsible for all formulation and process development of several ongoing projects including project management* Managing projects by partnering and directly communicate with consultants, internal support groups, regulatory authorities, vendors/suppliers verbally and in writing to agree on development approaches and scope of work based on analytical data* Ensuring that all formulation and development work is accurate, precise, properly documented and, when appropriate, performing within GXP guidelines and in accordance with oral solid dosage form processes* Maintaining competence and training documentation for relevant equipment and processes* Performing risk assessments and determine QTPP/CQA before transferJOB TIME: Full TimeCatalent 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 ...@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 ...@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.