DEVELOPMENT SCIENTIST I
General Function
With general supervision assist and support process development, clinical trial batch manufacturing, packaging and documentation.
Typical Description of work
- Clinical trial batch manufacturing and packaging
- Stability testing
- Documentation, including regulatory submission writing
- With general supervision, develop and optimize suitable formulations and processes
- With general supervision, manufacture development, stability, and clinical trial batches
- Design and perform experiments with general supervision
- Assist others in solving technical issues
- With general supervision, interpret data, draw conclusions, and make sound recommendations based on the data
- With general supervision, solve formulation and process problems
- With general supervision author: SOPs, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions, as directed
- Ensure that all work is accurate, precise, properly documented and performed within GMP requirements
- Maintain competence and training documentation for relevant development equipment and processes
- Complete projects on time
- Maintain an accurate, well–kept laboratory notebook to document development work
- Help develop analytical specifications and stability protocols
- Make commitment of own time and resources to assigned projects
- Witness lab notebooks of other staff and provide feedback on writing effectiveness
Typical Interactions
- With general supervision,
serve as a liaison on projects being conducted with
client companies
- With guidance from senior
staff, discuss formulations and processes with client
representatives
- Recommend development strategies
to senior staff
- Keep management informed
of project status and issues
- Effectively supervise and
manage assigned staff
- Work closely with analytical
chemists to develop tests to provide quality control
for pharmaceutical raw materials, drug substances,
and dosage forms
- Train new staff in general
pharmaceutical development methods and GMP compliance
- Train staff in the
use of specific equipment and technology
Minimum Requirements
- Pharm.D. or Master’s degree in pharmacy or
- Master’s or Bachelor’s degree in chemistry, engineering, or related science with 2 years equivalent industrial pharmaceutical experience or
- AAS degree, HS diploma or GED with five years of equivalent industrial pharmaceutical experience
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this position.
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