R&D Scientist, Analytical Chemistry & GMP Compliance

Xttrium Laboratories, Inc.; Mount Prospect (IL); Hybrid; USD 75,000 - 95,000; Full time

Job summary

Xttrium Laboratories, located in Mount Prospect, IL, seeks an R&D Scientist to advance analytical development and formulation support in a GMP/GLP environment. The role involves executing method verification/validation according to ICH/FDA and maintaining data integrity.

Qualifications include a Bachelor’s or Master’s in Analytical Chemistry, Pharmaceutics or Biochemistry and 1 year of relevant experience, with strong written and verbal communication skills.

Qualifications

• Bachelor’s or Master’s Degree in Analytical Chemistry, Pharmaceutics or Biochemistry.
• Minimum 1 year of experience in formulation / Analytical Chemistry.
• Experience with analytical techniques: UV/Vis, IR, pH meter, titration, Karl Fischer, GC, HPLC.
• Knowledge of FDA/ICH guidelines and Pharmacopoeias.
• Good written and verbal communication skills.

Responsibilities

• Execute Analytical Method Verification / Validation per ICH / FDA requirements.
• Formulate lab-scale batches of products and placeboes to support development.
• Document analytical activities and maintain data integrity under GLP compliance.
• Ensure all analytical data meet current standards of compliance (including electronic data and audit trails).
• Keep inventory of reference standards, reagents, columns, equipment parts and order as needed.
• Ensure all duties in R&D comply with FDA, OSHA, and GMP systems.
• Timely communication to escalate quality issues to management.

Skills

UV/Vis

IR

pH meter

Titration

Karl Fischer

GC

HPLC

Communication skills

Education

Bachelor’s or Master’s Degree in Analytical Chemistry/Pharmaceutics/Biochemistry

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

R&D Scientist

MOUNT PROSPECT, IL, US

30+ days ago Requisition ID: 1013

Our Solutions Protect Patients!

Founded in 1932, Xttrium Laboratories has been dedicated to promoting health and well-being through high-quality products. Recognized as a trusted supplier of disinfectants to hospitals and healthcare providers, Xttrium has expanded its offerings to pharmacies nationwide. With over 40 years of expertise in manufacturing FDA-registered healthcare solutions, the company is a leader in ensuring safety and quality in a health-conscious world.

Xttrium is looking for an R&D Scientist.

Description:

• Execute Analytical Method Verification / Validation activities of Pharmaceutical Drug Products as per current ICH / FDA requirements.
• Formulate Lab scale batches of Products and placeboes to support Analytical and formulation development.
• Document analytical activities and maintain data integrity as an integral part of GLP compliance.
• Ensure all analytical data (including electronic data and audit trial) generated in the Laboratory are meeting current standards of compliance.
• Keep inventory of reference standards, reagents, columns, equipment parts and order as needed.
• Ensure all duties and activities associated with R&D Department are carried out in compliance to FDA, OSHA, and GMP systems.
• Timely and effective communication to escalate Quality issues to the appropriate level of the management.

Knowledge:

• Experience with the following analytical techniques:
  UV/Vis, IR, pH meter, wet chemistry techniques, titration, Karl Fisher titration, GC, and HPLC.
• Knowledge of the most current FDA/ICH guidelines and Pharmacopoeias is required.
• Understanding and familiarity with analytical regulatory requirement for ANDA submissions.
• Must possess good written and verbal communication skills.

Education:

• Bachelor’s or Master’s Degree in scientific disciplines such as Analytical Chemistry, Pharmaceutics orBiochemistry.
• Minimum 1 year of experience in formulation /Analytical Chemistry, with significant knowledge of analytical chemistry techniques demonstrated through a combination of industry and academic performance.

Expected compensation for this role will be $75,000 and 95,000 on a full-time basis plus applicable health and ancillary benefits offered by the company. Final compensation may differ based on a number of various factors.