FORMULATION SCIENTIST
PRIMARY PURPOSE OF POSITION:
- Design, characterize, formulate, and transfer existing drug products (liquid, lyo, emulsion and suspension) to scale-up manufacturing.
- Perform feasibility studies, method development, and method validation for various analytical instruments (e.g. HPLC, UV, and Particle Sizer)
- Compound lab batches and design accelerated stability studies to determine optimal drug products shelf life.
- Manufacturing comprehension (i.e. aseptic techniques, equipment specifications, product filter requirements, etc.)
- Generated monographs, specifications, compounding records, and various technical protocols/reports including CMC sections for FDA submissions of drug products.
MINIMUM QUALIFICATIONS:
M.S. Degree in Chemistry, Biochemistry, Biology preferred or B.S. Degree in Chemistry, Biochemistry, Biology with 4+ years experience in the pharmaceutical industry
- Design, characterize, formulate, and transfer existing drug products (liquid, lyo, emulsion and suspension) to scale-up manufacturing.
- 5+ years experience with HPLC, GC, AA, and UV/Vis
- Strong comprehension of USP, EP and other compendial methods and procedures
- Able to work effectively and efficiently in a demanding, dynamic environment
- Strong computer skills in Windows, Word and Excel
- Strong oral and written communication skills
Candidates must possess:
- Excellent oral and written communication skills
- Ability to write scientifically sound protocols and reports for all development activities
- Proficient knowledge about FDA, USP, EP and ICH Regulatory Guidelines
- Skills working on diverse and complex parental and ophthalmic formulations, analytical techniques, and ANDA/NDA regulatory submissions
- Candidate is required to work under cGMP conditions and possess excellent laboratory practices.
- Must be pro-active and capable of working independently and/or in a Team environment
Utilization of the following instrumentation is preferred:
- HPLC (Agilent and/or Waters, using Chromeleon and/or Millennium software systems)
- Ability to write scientifically sound protocols and reports for all development activities
- Viscometer
- Particle Size analyzer
- Lyophilizer
- Osmometer
- pH
- Densitometer
- Coulometer (% Water determination)
- Microscope (compound and/or freeze drying
FORMULATION SENIOR SCIENTIST
PRIMARY PURPOSE OF POSITION:
- Design, characterize, formulate, and transfer existing drug products (liquid, lyo, emulsion and suspension) to scale-up manufacturing.
- Perform feasibility studies, method development, and method validation for various analytical instruments (e.g. HPLC, UV, and Particle Sizer).
- Compound lab batches and design accelerated stability studies to determine optimal drug products shelf life.
- Manufacturing comprehension (i.e. aseptic techniques, equipment specifications, product filter requirements, etc.)
- Generated monographs, specifications, compounding records, and various technical protocols/reports including CMC sections for FDA submissions of drug products.
Contribute to the conceptualization and development of new procedures, systems, and techniques:
- Design and conduct pre-formulation/formulation studies and assess new product feasibility
- Design and execute method development and method validation activities within a cGMP environment
- Assist in training and supervising other scientists and/or Associates
- Plan and execute laboratory experiments, technical activities, and professional services, while coordinating all necessary resources
- Support Quality Assurance/Regulatory Affairs by assembling methodology and data for submission of regulatory documents and FDA investigations with minimal oversight from department management
- Write protocols, scientific reports and participate in the interpretation of data, collaborating with other departments
- Write and review reports, protocols, and other technical documents
- Troubleshoot instrumentation when needed
MINIMUM QUALIFICATIONS:
M.S. Degree in Chemistry, Biochemistry, Biology preferred or B.S. Degree in Chemistry, Biochemistry, Biology with 4+ years experience in the pharmaceutical industry
- 5+ years experience with HPLC, GC, AA, and UV/Vis
- Strong comprehension of USP, EP and other compendial methods and procedures
- Able to work effectively and efficiently in a demanding, dynamic environment
- Strong computer skills in Windows, Word and Excel
- Strong oral and written communication skills
Candidates must possess:
- Excellent oral and written communication skills
- Ability to write scientifically sound protocols and reports for all development activities
- Proficient knowledge about FDA, USP, EP and ICH Regulatory Guidelines
- Skills working on diverse and complex parental and ophthalmic formulations, analytical techniques, and ANDA/NDA regulatory submissions
- Candidate is required to work under cGMP conditions and possess excellent laboratory practices.
- Must be pro-active and capable of working independently and/or in a Team environment
Utilization of the following instrumentation is preferred:
- HPLC (Agilent and/or Waters, using Chromeleon and/or Millennium software systems)
- Ability to write scientifically sound protocols and reports for all development activities
- Viscometer
- Particle Size analyzer
- Lyophilizer
- Osmometer
- pH
- Densitometer
- Coulometer (% Water determination)
- Microscope (compound and/or freeze drying