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:

• Demonstrated success in moving R&D project through multiple development stages; in product development from early stage to regulatory filing.
• Extensive knowledge in advanced drug delivery systems and their pharmaceutical applications, such as emulsions, suspensions, polymer, nanoparticle, and colloidal systems.
• Familiar with common and advanced physicochemical characterization techniques used in the development of complex injectables.
• Familiar with regulatory requirements, such as FDA and ICH guidelines.
• Demonstrated ability to work as part of a cross-functional team.
• Ability to communicate in an open, clear, timely and consistent manner.
• Ability to thrive and to lead in an environment with rapidly changing priorities.

Education/Experience:

• Ph.D. in Pharmaceutical Science, Chemical Engineering, or related disciplines, with 5 - 7 years of relevant experience in a pharmaceutical R&D environment. (Strong candidates with combinations of education and experience will be considered.)
• Hands-on experience in lab and commercial-scale development of complex injectable products.

• Experience representing functional teams or cross-functional teams is highly desirable.