|| Associate Scientist
We are seeking an Associate Scientist to join our Formulation team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development, scale-up, and validation activities for both ANDA and NDA projects.
- Assist Formulation Scientists in design and develop of formulations and processes for new drug products, with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
- Assist Formulation Scientists in set-up, operation, and execution of R&D lab experiments
- Create and follow protocol and batch records in manufacturing development batches
- Perform laboratory assignments and evaluate testing results
- Document experiments in lab notebooks, write experimental batch records, stability study protocols, and product development reports
- Assist in manufacturing of development, optimization, scale-up, and submission batches
- Help troubleshoot formulation issues that occur during R&D development, scale-ups and/or in production
- Communicate and present results through oral and/or written updates and formal reports, as needed to internal and external project teams
- Attend SOP, safety and scientific training’s to remain current with cGMP regulations, safety standards, and development technologies
- Follow relevant Frontida SOP’s and FDA/ICH guidance
Knowledge, Skills and Abilities
- Bachelor degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Material Science or equivalent with 0-2 years of experience.
- Knowledge of pharmaceutical formulation development principles, QbD, CMC regulation and organization skills
- Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- High degree of professionalism, ethics and integrity
- Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
- Willing to participate in our group identity characterized by commitment, trust, and care for each other.
- Willing to invest time and energy in continuous improvement efforts