Job Code FDRA 2018
We are currently looking for a Formulation Development Research Associate / Scientist to assist in the formulation development efforts for our clinical and preclinical drug development programs. Working closely with the Formulation Development Group Leader, the successful candidate will assist in the development of pharmaceutical drug products by performing preformulation and formulation screening experiments, as well as preparing materials for preclinical studies. Under general supervision, the candidate will work collaboratively with other scientists and disciplines (pharmacology, chemistry, pharmaceutical development, toxicology and clinical operations) to develop and prepare drug product test formulations for preclinical evaluation. You will be expected to have excellent documentation skills and be able to summarize all activities and data to allow for experimental reproducibility and communicating the supporting rationale. Most importantly the successful candidate will be self-motivated, capable of working independently and creatively under general supervision; able to follow instructions, generate data that can be traceable and substantiated, and assist with writing reports and data summaries. As needed, the candidate may assist other departments/disciplines such as Analytical Development with method development, sample prep, analysis, etc. Additionally, the candidate may support drug product process development studies, process optimization, scale up and tech transfer to 3rd party CMO's.
- Design and develop fit for purpose preclinical formulations (traditional and enabling)
- Coordinate and contribute to drug substance and drug product characterization and stability studies to ensure optimal formulation development and selection.
- Under minimal supervision, follows methods for the production and testing of new sub-cutaneous and oral formulations, technologies and products.
- Assists with new product scale-up, process optimization, technology transfer and process validation activities.
- Generates data to support the development of manufacturing procedures and product specifications. Write, review, and edit technical documents.
- Maintains an accurate, timely, and GLP compliant laboratory notebook.
- Participate in and contribute at team meetings.
- BS/MS degree with >10 years or PhD degree with >5 years of relevant pharmaceutical industry experience working with formulation development. Solid understanding on pharmaceutical sciences and its interplay with other relevant scientific disciplines. Experience with peptide immediate and sustained release formulation development and/or small molecule solid dosage form development. .
- Able to solve technical problems with enthusiasm in a team environment
- Good written and oral communication skills.
- Ability to thrive and develop in a biotechnology culture
- Execute studies and research with a sense of urgency and attention to detail
- Aseptic technique desirable
We provide a highly stimulating working environment coupled with a high level of intellectual challenge. We offer a very competitive salary and benefits program. Ra Pharmaceuticals, Inc. is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V