Formulation Scientist

Formulation Scientist

Overview:

A mid-sized pharmaceutical development organization is seeking a Senior Scientist to join its Formulation and Process Development team. This role is ideal for a hands-on scientist with experience in developing generic oral and liquid dosage forms, from early-stage formulation through to submission batch manufacturing. The position offers the opportunity to work on a diverse portfolio of products in a collaborative, fast-paced environment focused on innovation and regulatory excellence.

Key Responsibilities:

• Lead formulation development activities for oral solids and liquid dosage forms, including tablets, capsules, and suspensions.
• Utilize technologies such as fluid bed drying (FBD), compression, and encapsulation to develop robust and scalable formulations.
• Conduct comprehensive literature reviews to support formulation strategy and regulatory positioning.
• Apply Quality by Design (QbD) principles to guide product development and ensure regulatory compliance.
• Manage projects from bench-scale development through scale-up and submission batch manufacturing, collaborating closely with cross-functional teams.
• Prepare technical documentation to support regulatory filings, including ANDAs and, where applicable, NDAs.
• Maintain awareness of current regulatory expectations and industry trends to inform development strategies.
• Troubleshoot formulation and process challenges, proposing innovative solutions to meet product performance and stability requirements.

Qualifications:

• Bachelor's, Master's, or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry, or a related field.
• 3-5 years of hands-on experience in formulation and process development within the generic pharmaceutical industry.
• Proven track record of contributing to successful ANDA submissions.
• Strong understanding of pharmaceutics, pharmacokinetics, and process scale-up principles.
• Excellent communication skills, both written and verbal, with the ability to work effectively in cross-functional teams.
• Must be legally authorized to work in the United States without sponsorship.
• Reliable transportation and flexibility to work overtime as needed.

Why Join Us?

This is a high-impact role within a growing pharmaceutical company committed to expanding access to affordable medicines. You'll be part of a team that values scientific rigor, regulatory integrity, and continuous improvement. The company offers competitive compensation, professional development opportunities, and a collaborative work culture.