Title: Associate Scientist

Job Summary

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.

Responsibilities

  • 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
  • Other duties as assigned

Qualifications

  • 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
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