Position: Scientist/Senior Scientist, Formulation (Biologics)
Position Overview: We are looking for a highly motivated Formulation Scientist with expertise in Protein Biologics to join our team. The ideal candidate will have a strong background in the formulation of Protein Biologics, and will thrive in a GMP environment. The successful candidate will play a critical role in the development and optimization of formulations for clinical and commercial-stage products.
Key Responsibilities:
- Develop and optimize formulations for monoclonal antibodies, antibody-drug conjugates (ADCs), and fusion proteins to meet product specifications and regulatory requirements.
- Conduct stability studies and assess the impact of formulation changes on product quality, efficacy, and safety.
- Collaborate with cross-functional teams, including Analytical Development, Process Development, and Quality Assurance, to ensure seamless integration of formulation strategies.
- Prepare and review documentation related to formulation development, including protocols, reports, and regulatory submissions.
- Troubleshoot and resolve formulation-related issues that arise during the development process.
- Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes affecting biologics formulation.
- Ensure all activities are conducted in compliance with GMP regulations and company policies.
Qualifications:
- Master's degree in Pharmaceutical Sciences, Chemistry, or a related field.
- Minimum of 2 years of industry experience in formulation development of protein biologics, including monoclonal antibodies, ADCs, and fusion proteins.
- Hands-on experience in GMP environments, with a solid understanding of regulatory guidelines and quality standards.
- Proficiency in analytical techniques used for characterizing protein formulations, such as HPLC, SEC, and particle size analysis.
- Strong problem-solving skills and the ability to work independently as well as part of a collaborative team.
- Excellent communication skills, both written and verbal, with a proven ability to present complex data and concepts clearly.
- Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.
Preferred Qualifications:
- Experience with biologics manufacturing processes and scale-up activities.
- Knowledge of advanced formulation strategies and technologies, such as lyophilization and formulation of complex drug delivery systems.
- Familiarity with regulatory submissions (e.g., IND, BLA) and interactions with regulatory agencies.
