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DEVELOPMENT
SCIENTIST II
General Function
With minimal supervision assist
and support process development, formulations, clinical
trial batch manufacturing and packaging, stability
testing, and documentation including regulatory submission
writing.
Typical Description of Work
- With minimal supervision,
develop and optimize suitable formulations and processes
- With minimal supervision,
manufacture development, stability, and clinical
trial batches
- Design and perform experiments
independently
- Interpret data, draw conclusions,
and make sound recommendations based on data
- Solve formulation and process
problems
- With minimal supervision
author: SOPs, IQ/OQ/PQ documents, development and
technical reports, and CMC sections for regulatory
submissions, as directed
- Ensure that all work is
accurate, precise, properly documented, following
SOP’s performed within GMP requirements
- Assist Management in preparation
of a pharmaceutical budget
- Assist Management in identification,
interview, hiring, training, and managing of staff
- Assist Management in drafting
development plans and work agreements with clients
- 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
- Witness lab notebooks of
other staff and provide feedback on writing effectiveness
Typical Interactions
- With minimal supervision,
serve as a liaison on projects being conducted with
client companies
- Discuss formulations and
processes with client representatives
- Recommend development strategies
- Keep management informed
of project status and issues
- Effectively supervise and
manage assigned staff
- Work closely with analytical
chemists to develop a series of tests to provide
quality control for pharmaceutical raw materials,
drug substances, and dosage forms
- Help develop analytical
specifications and stability protocols
- Make commitment of own time
and resources to assigned projects
- Assist in identifying and
creating new customers and projects
- Train new staff in general
pharmaceutical development methods and GMP compliance
- Train staff in the use of
specific equipment/technology
Minimum Requirements
- Ph.D. in pharmaceutics with
one year industrial pharmaceutical experience or
- Pharm.D. or Master’s
degree in pharmacy with two years industrial pharmaceutical
experience or
- Bachelor’s degree
in pharmacy with three years industrial pharmaceutical
experience or
- Master’s or Bachelor’s
degree in chemistry, engineering, or related science
with five years industrial pharmaceutical experience
To be considered for this position email your resume to Metrics, Inc. Careers
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