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新泽西研发公司求Formulation 和 Analytical Scientists,提供
[版面:制药][首篇作者:spespharma] , 2018年04月13日17:36:26 ,1169次阅读,1次回复
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发信人: spespharma (Spes), 信区: Pharmaceutical
标  题: 新泽西研发公司求Formulation 和 Analytical Scientists,提供sponsorship
关键字: Formulation,analytical,sponsorship
发信站: BBS 未名空间站 (Fri Apr 13 17:36:26 2018, 美东)

R&D Formulation and Analytical Scientist Positions at Spes Pharmaceuticals
Inc.

SPES Pharmaceuticals Inc., located in North Brunswick, New Jersey, is a
Delaware registered specialty pharmaceutical company focusing on development
of novel pharmaceutical products with propriety technologies. The R&D
Scientist roles are responsible for developing drug formulation and
manufacturing process technology. This is a great opportunity to learn about
exciting technologies and diverse product portfolio and to gain experience
working globally.

Job Responsibilities - Formulation Scientist:
The R&D Formulation Scientist will have the opportunity of working on all
aspects of product development cycle for selected drug products, such as
identifying/sourcing raw materials, developing formulation and process, and
managing product process scale-up, etc. Working on multiple projects
simultaneously independently or under the guidance of supervisor, this
individual will be responsible for designing experiments to support product
development as well as conducting hands-on laboratory and manufacturing
process development work in multi-functional team based environment.

Primary Responsibilities of the position include:
1. Design and conducting formulation and process development studies.  
2. Write and review technical documents including formulation development
protocols and reports, manufacturing process SOPs and other documents.
3. Establish drug product specifications.
4. Maintain product knowledge:
a. Write reports and memos to record technical investigations or
recommendations, ensuring data integrity.
b. Contribute to and/or coordinate quality risk assessments and technical
opportunity and risk assessments.
c. Produce and maintain information in the product knowledge management tool.
d. Ensure delivery of product and process improvements that will deliver
business benefits.

Qualifications:
1. Knowledge of preformulation and formulation development of injectable or
solid oral pharmaceuticals.
2. Knowledge of the overall drug development and commercialization process
from development, launch and through life cycle management
3. Ability to apply the principles of the basic sciences such as physical
and organic chemistry, thermodynamics, and materials science, to formulation
development, using a rational, scientific approaches.
4. Self-motivated, team player and have the ability to work with tight
timelines; adapt to changing priorities in a fast paced environment.
5. Knowledge of US FDA registration and ICH guidelines.
6. BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences.


Job Responsibilities - Analytical Scientist:
The R&D Analytical Scientist will have the opportunity of working on all
aspects of product development cycle for selected drug products, such as
developing product specifications and required analytical methodologies, and
providing analytical supports for the formulation and CMC developments.
Working on multiple projects independently or under the guidance of
supervisor, this individual will be responsible for designing and executing
analytical experiments to support product development in multi-functional
team based environment.
Primary Responsibilities of the position include:
1. Must be fully capable of developing analytical methods based on
experience, literature search, etc.
2. Design, develop, conduct and/or review experiments including method
development and method transfer; perform methods validations utilizing
typical instrumentation including but not limited to LC-MS, GC, etc.
3. Perform data audits in order to ensure accuracy of data and analytical
processes;
4. Organize workflow and tasks to maximize laboratory efficiency (e.g.,
prioritize sample analysis, manage/assign tasks, preventative maintenance);
5. Maintain laboratory equipment and instrumentation (e.g., troubleshooting,
conducting preventative maintenance, calibrating and repairing);
6. Prepare samples for analysis and record data from analyses or experiments
in a computer, log book, or laboratory notebook;

Qualifications:
1. Knowledge of analytical and CMC development for injectable or solid oral
pharmaceuticals.
2. Ability to apply the principles of the basic sciences such as physical,
organic and analytical chemistry to analytical development.
3. Self-motivated, team player and have the ability to work with tight
timelines; adapt to changing priorities in a fast paced environment.
4. Hands-on analytical research and development as well as method validation
experience is desired.
5. Knowledge of US FDA regulations, ICH guidelines and USP is desired.
6. BS, MS, or PhD in Chemistry, Analytical chemistry or Pharmaceutical
Sciences.

Benefits :
We will provide competitive benefits and sponsorship.

Contact Information:
Tel: 732-354-3630
Email:[email protected]


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