What are the responsibilities and job description for the Senior Research Associate position at Alvogen?
SUMMARY OF POSITION
The Analytical R&D Sr. Research Associate:
Provides analytical support of product development, including sample analysis and method pre-validation, accurately and concisely documents data, and reports results. Performs various analytical testing, including dissolution, HPLC and GC testing following established testing procedures for raw materials, finished products, and/or stability samples. Demonstrates a comprehensive knowledge of SOP's and cGxP regulations as related to the pharmaceutical analytical laboratory.
ORGANIZATION STRUCTURE
The Analytical R&D Sr. Research Associate reports to the Principal Scientist/Research Fellow, Analytical R&D.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
- Organize work schedule to complete assigned tasks efficiently and on schedule to ensure adherence to "Right-the First Time" philosophy
- Perform various analytical testing, including by Dissolution, HPLC, UV and GC following established testing procedures for raw materials, finished products, and/or stability samples
- Comprehend and follow established plan accurately in the performance of method pre-validations
- Comprehend and follow established testing procedures accurately in the performance of sample analysis
- With practical understanding of instrument operation, use available software to control instrumentation, collect data, process and calculate results, and report results
- Perform testing to evaluate physical characteristics of raw materials and finished products
- Independently organize work schedule to complete assigned tasks efficiently and on schedule
- Work with minimal supervisory direction for routine tasks
- Maintain accurate record of analysis and perform documentation to company standards
- Perform job functions in a safe manner consistent with site safety practices and regulatory (e.g. - OSHA) requirements
- Other duties as assigned
QUALIFICATIONS
- BS or MS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
- 3-5 years of experience for MS, 4-7 years of experience for BS in a pharmaceutical laboratory environment
- Understanding of cGXP requirements preferred
- Organization, communication and interpersonal skills
GMP DECISION-MAKING AUTHORITY
Responsible for decisions related to:
- When laboratory management must be notified to determine whether an investigation is warranted.
- Whether they have been trained to perform a GMP task.
- Suitability of analytical equipment/instruments for use.
"An Equal Opportunity Employer, including disability/vets."
EOE/M/F/Vet/Disability
