Scientist, Laboratory
Automation
Pharmaceutical company located in New York seeks a
Scientist, Laboratory Automation. Responsibilities will
include:
Co-develop methods on various robotic platforms including,
Zymark/Caliper TPWII and MultiDose with goal of increasing
ruggedness and efficiency.
Contribute to the transfer of test methods to affiliates.
Provide feedback on how to utilize robotics effectively
as well as work with various departments to address
automation needs.
Validate new and existing methods
Coordinate or perform repairs, perform preventative
maintenance for multi-site laboratory installations
Conduct user training
Requirements:
BS/MS with 8-10 years of relevant experience.
Strong working knowledge of automation technologies
and laboratory data systems.
In-depth understanding of cGMP and relevant ICH guidelines
and FDA guidances.
Excellent oral and written communication skills
Experience supporting analytical and drug development
a plus.
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Research
Scientist III
A pharmaceutical company located in New Jersey seeks
a Research Scientist III.
Position Summary: Designs, executes and interprets formulation
and process development experiments leading to the development
of dosage forms of selected drugs for commercialization.
Supports either Solid Dose or Aerosol Research&
Development.
Responsibilities:
1. Perform tasks assigned by Supervisor with minimal
instruction.
2. Collaborate with members of other departments and/or
formulation teams for proper project planning and product
design.
3. Prepare and maintain R&D projects documentation
including specifications, batch records, development
reports, technical reports, submission documentation,
and laboratory notebooks in orderly, complete and up-to-date
fashion.
4. Employ tools in physical pharmacy (e.g., solubility,
partition coefficient, phase equilibra, micromeritics)
to develop robust drug delivery systems and platforms.
5. Develop pharmaceutical formulation systems including
characterization and control of raw materials, excipients,
packaging components, and final products.
6. Manufacture clinical supplies to support preclinical
and clinical studies of selected pharmaceutical formulations.
7. Carry out pilot scale operations, optimization studies
and transfer to Process Engineering of selected products.
8. Provide formulation data to support the development
of material and product specifications in a timely manner.
9. Perform and report the necessary documentation to
support regulatory filings such as Investigational New
Drug Applications (INDs), New Drug Applications (NDAs),
Abbreviated New Drug Applications (ANDAs), IND, NDA
and ANDA supplements and annual reports, as required.
10. Write and/or update Standard Operating Procedures
(SOPs) and other documents as required.
Experience:
BS, MS, or PhD Degree in Pharmaceutics, Industrial Pharmacy,
Chemical Engineer, Polymer Science or related discipline
with 8+,5+, or 0-4 years of hands on R&D experience,
respectively. Must have experience in pharmaceutical
industry with a broad understanding of drug development
process. Must have experience in physicochemical characterization
of bulk drug and formulation development of relevant
dosage forms. This position requires strong knowledge
of pharmaceutical sciences and excellent written and
oral communication skills. Must be able to design experiments
in support to formulation and regulatory submissions.
Must be highly motivated, able to work independently.
Requirements:
1. General: Basic statistics, interpretation of experimental
results, technical protocol and report writing, knowledge
of pharmaceutical processes, pharmaceutical compounds
and excipients
2. Analytical: Ability to perform analytical testing,
as appropriate to formulation development activities,
and interpret results.
3. Manufacturing/Packaging Equipment: All solid dose
processing equipment including, granulators, blenders,
tablet presses, tablet coating machines, encapsulators
etc..
4. Administration: Organization skills, documentation
accuracy, auditing skills, protocol and report writing,
reliability
5. Computer: Proficiency in the use of word processing
software such as WordPerfect or Microsoft Word, and
spreadsheet calculation software such as Lotus or Excel.
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