AptaPharma
Senior Analytical Chemist
AptaPharma, Pennsauken, New Jersey, United States,
Senior Analytical Scientist
Location: Pennsauken, NJ
Position Type: Full Time
Required Education: Master’s Degree
Areas of Expertise Desired: Analytical R&D
Description
AptaPharma is a technology-based pharmaceutical company which offers a broad range of drug delivery technologies and provides full product development and contract manufacturing services for the pharmaceutical industries. AptaPharma mainly focuses on developing liquid formulations and oral solids that present competitive barriers to entry, and complex formulations.
The Senior Analytical Scientist / Chemist is a highly motivated individual with strong career aspirations, providing leadership to employees and completing associated documentation.
Responsibilities:
With minimal supervision, perform analytical method development and validation for dissolution, preservative assay, particle size, assay, and impurities of raw material and finished products (prior experience in pharmaceutical oral solutions and suspensions is desired).
Perform analytical method validation for dissolution, preservative assay, particle size, assay, and impurities of finished products (for oral solutions and suspensions) using sophisticated instrumentation such as HPLC, GC, UV-Vis, FTIR, dissolution apparatus, particle size analyzer (Malvern), etc.
Perform complex tests and analysis of pharmaceutical raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning verification/validation samples, and stability samples using sophisticated instrumentation such as HPLC, GC, UV-Vis, FTIR, dissolution apparatus, particle size analyzer (Malvern), etc. to support formulation development.
Responsible for the timely and accurate execution of lab analysis.
Independently compile analytical data, make sound judgments of the data, interpret the data, and notify the results to supervisor/manager.
Maintain full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
Manage USP reference standards and the qualification of secondary standards, as needed.
Maintain laboratory notebooks and records of all raw data as per Good Documentation Practices.
Assist with training other junior members of the analytical development team as needed.
Desired Skills & Experience
The position requires an M.S. or Ph.D. in Pharmaceutical Chemistry, Analytical Chemistry, or Pharmaceutical Sciences with relevant working experience in the pharmaceutical industry.
Must have at least 5-8 years of experience in the advertised position as a senior chemist/scientist role.
Hands-on experience in Dissolution, HPLC, GC, UV, FTIR, and other laboratory instruments.
Experience with a wide variety of software and information systems (e.g., Empower, Microsoft Word, and Excel).
Strong knowledge in analytical method development and validation under cGMP environment and experience in problem-solving skills and instrument troubleshooting.
Good oral and written communication skills and the ability to write and review technical reports.
Job Type:
Full-time
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Education:
Master's (Required)
Experience:
CGMP: 4 years (Preferred)
Laboratory Experience: 8 years (Required)
Work Location:
In person
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Location: Pennsauken, NJ
Position Type: Full Time
Required Education: Master’s Degree
Areas of Expertise Desired: Analytical R&D
Description
AptaPharma is a technology-based pharmaceutical company which offers a broad range of drug delivery technologies and provides full product development and contract manufacturing services for the pharmaceutical industries. AptaPharma mainly focuses on developing liquid formulations and oral solids that present competitive barriers to entry, and complex formulations.
The Senior Analytical Scientist / Chemist is a highly motivated individual with strong career aspirations, providing leadership to employees and completing associated documentation.
Responsibilities:
With minimal supervision, perform analytical method development and validation for dissolution, preservative assay, particle size, assay, and impurities of raw material and finished products (prior experience in pharmaceutical oral solutions and suspensions is desired).
Perform analytical method validation for dissolution, preservative assay, particle size, assay, and impurities of finished products (for oral solutions and suspensions) using sophisticated instrumentation such as HPLC, GC, UV-Vis, FTIR, dissolution apparatus, particle size analyzer (Malvern), etc.
Perform complex tests and analysis of pharmaceutical raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning verification/validation samples, and stability samples using sophisticated instrumentation such as HPLC, GC, UV-Vis, FTIR, dissolution apparatus, particle size analyzer (Malvern), etc. to support formulation development.
Responsible for the timely and accurate execution of lab analysis.
Independently compile analytical data, make sound judgments of the data, interpret the data, and notify the results to supervisor/manager.
Maintain full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
Manage USP reference standards and the qualification of secondary standards, as needed.
Maintain laboratory notebooks and records of all raw data as per Good Documentation Practices.
Assist with training other junior members of the analytical development team as needed.
Desired Skills & Experience
The position requires an M.S. or Ph.D. in Pharmaceutical Chemistry, Analytical Chemistry, or Pharmaceutical Sciences with relevant working experience in the pharmaceutical industry.
Must have at least 5-8 years of experience in the advertised position as a senior chemist/scientist role.
Hands-on experience in Dissolution, HPLC, GC, UV, FTIR, and other laboratory instruments.
Experience with a wide variety of software and information systems (e.g., Empower, Microsoft Word, and Excel).
Strong knowledge in analytical method development and validation under cGMP environment and experience in problem-solving skills and instrument troubleshooting.
Good oral and written communication skills and the ability to write and review technical reports.
Job Type:
Full-time
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Education:
Master's (Required)
Experience:
CGMP: 4 years (Preferred)
Laboratory Experience: 8 years (Required)
Work Location:
In person
#J-18808-Ljbffr