Senior Scientist, Drug Product Development

Senior Scientist, Drug Product Development

Greater Philadelphia Area

Position Overview : The Senior Scientist, Formulation will play a critical role in advancing our biologics and cell / gene therapy programs.

This individual will leverage their extensive experience in traditional biologics (such as monoclonal antibodies, antibody-drug conjugates, and fusion proteins) or cell and gene therapies to lead formulation development efforts.

The ideal candidate will have a proven track record of guiding programs through early to late-stage development, and will possess deep expertise in the formulation and stability of complex biological products.

Key Responsibilities :

Formulation Development : Lead the design, development, and optimization of formulations for biologics and cell / gene therapies.

Develop strategies to address formulation challenges and enhance product stability, efficacy, and manufacturability.

Program Leadership : Oversee and drive formulation activities from early-stage development through late-stage clinical trials.

Collaborate with cross-functional teams to ensure successful progression of programs.

• Technical Expertise : Utilize extensive knowledge of traditional biologics or cell and gene therapies to solve complex formulation issues and ensure product quality.
• Experimental Design : Plan and execute experimental work to support formulation development, including stability studies, and formulation optimization.

Analyze data and interpret results to guide decision-making.

Regulatory Compliance : Ensure that formulation development activities comply with regulatory guidelines and industry standards.

Prepare and review documentation for regulatory submissions.

• Innovation : Stay alert of industry trends and emerging technologies. Identify and implement new techniques and methodologies to improve formulation processes and product outcomes.
• Team Collaboration : Mentor and provide technical guidance to junior scientists and team members. Foster a collaborative environment and contribute to a culture of scientific excellence.

Qualifications :

• Education : Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field with a focus on biologics or advanced therapies.
• Experience : Minimum of 4 5 years of industry experience in formulation development, with significant experience in traditional biologics (e.

g., monoclonal antibodies, ADCs, fusion proteins) or cell and gene therapies. Proven track record of leading programs through early to late-stage development.

• Expertise : Deep understanding of formulation principles, stability studies, and analytical techniques. Experience with both preclinical and clinical-stage development.
• Leadership : Demonstrated ability to lead projects and mentor team members. Strong project management skills with experience in cross-functional collaboration.
• Regulatory Knowledge : Familiarity with regulatory requirements and guidelines related to biologics and advanced therapies.
• Communication : Excellent verbal and written communication skills. Ability to present complex data and concepts clearly to diverse audiences.
24 days ago