CDC Global are delighted to be partnered with a fast-paced, developing CDMO team as we look for a Formulation specialist. MUST have Sterile Injectable experience!
Overview:
The Principal Formulation Scientist will be leading formulation development activities on multiple projects. The individual will perform and oversee all aspects of product development including pre-formulation, formulation, technology transfer, scale-up, and registration batch manufacturing activities of sterile injectable products. The individual will work in multidisciplinary teams and with CROs in support of drug product development, scale-up, manufacturing, and regulatory filing. The title will be determined based on qualifications.
Responsibilities:
• Represent product development or CMC development of complex sterile injectable products.
• Design and conduct pre-formulation, formulation, process, sterilization, scale-up, stability, and container closure studies.
• Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues.
• Prepare manufacturing batch records, technical reports, development reports, and CMC documents to support regulatory submissions (e.g., IND, NDA & ANDA’s).
• Represent product development and CMC in cross-functional teams, collaborate with internal and external stakeholders and partners, such as development, Quality, and manufacturing.
• Define scope, timeline, and resource needs of functional activities and keep team on schedule.
• Identify and manage external vendors and partners when needed.
• Participate in evaluation of new product opportunities.
• Follow pharmaceutical cGMP practices and other relevant regulatory guidelines.
• Extended work hours may be occasionally required based on project needs.
• Additional duties and assignments as needed.
Qualifications:
Required Skills/Abilities:
Education/Experience:
• Experience representing functional teams or cross-functional teams is highly desirable.
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