Principal Formulation Scientist - Sterile Injectables

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 & ANDAs).

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 :

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