Sr. Analytical Scientist, Development

JOB DESCRIPTION

POSITION SUMMARY: Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified (Senior) Analytical Scientist to join our Analytical Chemistry team. The (Senior) Analytical Scientist is primarily responsible for the development of new analytical methods, including, but not limited to HPLC and GC.

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 applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

Key responsibilities.

• Develops analytical methods that are accurate, precise, and specific for use in both the Quality Control department and the Research department. Methods primarily include HPLC but also include ICP-MS, Karl Fisher, solid-state characterization, and others.
• Documents the development of the method in the appropriate notebooks for future reference. Performs pre-validation work ahead of transfer to the Validation Department to demonstrate suitability for use.
• Prepares test method procedures and supporting documentation for use in the Quality Control laboratory.
• May be required to develop validation protocols and validate analytical methods used in the testing of raw materials, intermediate products, final products, and cleaning samples.
• Assists in the maintenance and calibration of laboratory analytical instrumentation including, but not limited to HPLC and GC. Maintains accurate records regarding the maintenance and calibration activities.
• May support manufacturing operations with testing of raw materials, intermediate products, final products, and cleaning samples. The incumbent is expected to operate in a neat and orderly manner and to provide accurate and timely test results.
• Assists in the maintenance of the QC Laboratory. In addition to routine housekeeping and glassware cleaning, maintains and appropriate inventory of supplies and chemicals.
• Documents sample preparation, equipment set-up and test results in Laboratory Notebooks or on the appropriate test record form. Documentation must be complete and verified by a second member of the quality group. In addition, laboratory log sheets, those related to equipment usage, calibration, and maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples will be properly maintained.

EDUCATION/EXPERIENCE.

• To qualify as a Senior Analytical Scientist, you must have:
  • Ph.D. in Chemistry or Biochemistry and five (5) years' experience, OR
  • Master's Degree and ten (10) years' experience, OR
  • Bachelor's Degree and fifteen (15) years' experience in a related environment.

Any applicant not meeting the above criteria will enter as an Analytical Scientist.

job competencies.

• Strong knowledge of quantitative analysis. Must be able to convert between units easily and express results on demand as required based on need.
• Ability to develop sample preparation/dilution schemes as necessary to meet requirements for sensitivity, dynamic range, accuracy, and repeatability.
• Experience developing and optimizing chromatographic conditions, understanding the fundamental mechanisms of separation to do so efficiently. (Experience with novel method development highly desired)
• Experience with analysis of payload-linkers for ADCs highly desired.
• Knowledge of analytical instrumentation, particularly HPLC and GC.
• Basic understanding of organic chemistry to be able to communicate effectively with the Process Development team.
• Ability to reasonably predict the behavior of compounds in different contexts (e.g. solubility, chromatographic behavior, stability) based on structure.
• Hands-on experience with mass spectrometers and the ability to interpret mass spectra is highly desired.
• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Demonstrated proficiency for working collaboratively in a team environment.
• High attention to detail.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
• Proficiency with Microsoft Office Suite and industry-related software (Agilent OpenLab, etc.).

job conditions.

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical Demands:
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
  • Long periods of standing and walking can be expected in this position.
  • This position may require long periods of sitting, typing, computer entry or looking at a computer.

• Work Environment:
  • Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
  • Potential limited exposure to hazardous chemicals.
  • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

QUALIFICATIONS

EDUCATION/EXPERIENCE.

• To qualify as a Senior Analytical Scientist, you must have:
  • Ph.D. in Chemistry or Biochemistry and five (5) years' experience, OR
  • Master's Degree and ten (10) years' experience, OR
  • Bachelor's Degree and fifteen (15) years' experience in a related environment.

Any applicant not meeting the above criteria will enter as an Analytical Scientist.