Analytical Scientist

Piramal Pharma Solutions; Riverview (MI); On-site; USD 85,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Analytical Process Development Scientist to support and advance analytical methods for manufacturing processes. The role emphasizes development of in-process controls, solvent analyses, and impurity profiling using HPLC, GC, IR, LCMS, and KF, with strong emphasis on cGMP compliance and documentation.

The candidate will perform analytical testing on starting materials, intermediates, and APIs, maintain instrumentation, and contribute to method development

Qualifications

• PhD/masters/bachelors combinations matching the listed experience.
• Knowledge of analytical testing and instrumentation.
• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.

Responsibilities

• Generate analytical results to support development and optimization of manufacturing processes.
• Develop precise analytical methods for in-process control, cleaning verification, residual solvents, etc., and document methods.
• Operate and calibrate laboratory instrumentation (HPLC, GC, LCMS, KF) and maintain records.
• Prepare test methods and supporting documentation for QC and development use.
• Document sample prep, equipment setup and test results in notebooks and logs.
• Maintain inventory of supplies and chemicals and ensure timely test results.
• Participate in technical talks to address problems and propose future work.

Skills

Analytical method development

HPLC

GC

LCMS

IR

KF

In-process control

Education

Ph.D. in Chemistry/Biochemistry

M.S. in Chemistry/Biochemistry

B.S./Bachelors in related field

Tools

HPLC

GC

LCMS

KF

Job description

POSITION SUMMARY:

The Analytical Process Development Scientist is responsible for supporting Process Development through the use of established analytical methods, as well as the development of new analytical methods, identification and characterization of process impurities through their knowledge and experience of analytical and organic chemistry.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.


• Consistent support and practice of all Ash Stevens’ mission and values.


• Identify and protect the original technical information as part of the company property.

Key Accountabilities:

• Support the Process Development team by generating analytical results to help develop and optimize manufacturing processes.


• Develop precise analytical methods (for in-process control, cleaning verification control, residual solvents control, etc.) that can be used by both Quality Control and Process Development departments. Includes HPLC, GC, IR, LCMS, KF, and ROI and may extend to other testing procedures as well. Documents the development of the method in the appropriate notebook for future reference. Prepares and reviews ASI test methods and supporting documentation for use in the laboratory.


• Perform analytical tests to evaluate starting materials, intermediates, and APIs.


• Assist in the maintenance, troubleshooting, and calibration of laboratory analytical instrumentation including but not limited to HPLC, GC, LCMS, KF, solid state characterization. Maintain accurate records regarding maintenance and calibration activities.


• Document sample preparation, equipment set-up and test results in laboratory notebooks or appropriate test record forms. Maintain laboratory log sheets, for example, those related to equipment usage, calibration, maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples.


• In addition to routine housekeeping and glassware cleaning, maintain appropriate inventory of supplies and chemicals.


• Provide accurate and timely test results as required.


• Actively participate in technical talks to find solutions to different problems and carefully consider other opinions and suggestions for future work.

Experience/Education:

The successful candidate must meet one of the following education/experience combinations:

• Ph.D. in Chemistry or Biochemistry and 0-3 years’ experience; OR


• Master’s Degree and 3-5 years’ experience; OR


• Bachelor’s Degree and 5-10 years’ experience in a related environment.


• Knowledge of analytical testing and instrumentation


• Excellent organizational and planning skills.


• Strong written, verbal, and interpersonal communication skills.


• Self-motivated, creative, and independent.


• Ability to direct projects covering a variety of chemical compounds.


• Familiarity with cGMP, plant safety, and EPA requirements.