What are the responsibilities and job description for the Sr Pharmaceutical Development Scientist (Gainesville, GA) position at CEDENT?
In this role, you will support product development strategies on client projects and provide strategic input into departmental activities to ensure flexibility and timeliness in achieving client timelines. You will be responsible for the formulation development and process optimization of challenging pharmaceutical products such as controlled-release oral solid dosage forms (tablets, multiarticulate, etc.).
You Will Also
You Will Also
- Independently leads development activities for client-based projects, ranging from preclinical studies to NDA approval. This will include creating phase appropriate strategies for customer-defined product development projects.
- Execute prototype, scale-up and process transfer activities including manufacture, data evaluation, troubleshooting product/process issues, and risk assessments.
- Write, review, and approve cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.
- Maintain expert knowledge of equipment, instrumentation, and procedures related to product development.
- Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.
- Serve as lead for product development activities within pharmaceutical development group and on cross-departmental project teams, working closely with cross-functional groups to achieve project deliverables.
- Partners with the Department Director and other research experts to develop new concepts. Assists in developing project plans, business analysis, department budget planning and feasibility assessments.
- Identify and develop specific training content to support ongoing development efforts. Provide leadership and mentorship to junior team members. Support in developing group priorities, goals and objectives and support staff in achieving objectives. Ensure staff is adequately trained to perform job functions.
- Generally, twelve (12) years of experience in formulation and process development of oral solid dosage forms (tablets, capsules, multiparticulates) with a bachelor’s degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Pharmacology Or a master’s degree with eight (8) years of relevant experience.
- Generally, One (1) year of experience leading and managing teams.
- In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.
- Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.
- Proven experience with statistical design of experiments.
- Strong written and oral communication skills.
- Proficient in MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent.
- Ability to prepare presentations, speeches, and articles for publication that conform to prescribed style and format.
- Ability to present technical presentations to management, research teams and clients/potential clients to ensure understanding and responding to complex questions.
- Ability to apply logical or scientific thinking principles to a wide range of intellectual and practical problems.
- Strong working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regard to IID, GRAS, residual solvents, bioequivalence studies, etc. for oral formulations.
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