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.
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