Experienced Research Associate for Pharmaceutical Development
3 weeks ago
Job Overview
We are seeking a skilled and passionate Senior Research Associate to join our dynamic team at BioPhase. This is an exciting opportunity to contribute to the discovery and development of small molecule therapeutics in a well-funded, small company environment.
Key Responsibilities:
- Design and execute experiments to develop scientifically sound formulations and compounding procedures/manufacturing processes for solid and liquid oral dosage forms.
- Collaborate with cross-functional project teams to support pre-clinical studies, including Analytical Development and Toxicology.
- Prepare formulation study plans, development protocols, and reports, and analyze and interpret formulation development data.
- Maintain laboratory instruments and equipment, exploring options for capability enhancements.
- Present written and oral updates to supervisors and cross-functional teams regarding project status.
- Assist in preparing drug product sections for regulatory filings (INDs, IMPDs, NDAs).
Requirements:
- Bachelor's or Master's degree in chemistry, biology, or a related field, with 3-5 years of hands-on experience in a pharmaceutical, biotech laboratory, or CDMOs.
- Familiarity with laboratory-scale equipment for formulation and process development of early-phase dosage forms, including solutions, suspensions, powders for reconstitution, and powders in capsules.
- Understanding of cGMP requirements and regulatory guidelines (FDA, ICH).
- Strong written and verbal communication skills, with the ability to present data effectively to peers, management, and external partners.
- Excellent teamwork and goal-oriented skills, with the ability to manage competing priorities.
- Adaptability to a fast-paced environment with a keen attention to detail.
- Strong organizational skills and the ability to thrive under pressure.
- Intermediate to advanced proficiency in software applications (e.g., Microsoft Excel, PowerPoint, MS Project); experience with Empower software is a plus.
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