Analytical Chemist

McGuff Pharmaceuticals Inc. is seeking an Analytical Chemist for our Analytical Chemistry laboratory support for sterile and non-sterile drug manufacturing. This role will facilitate raw material and finished product method development and validation and testing (both GMP and development tests) and support the stability program for both commercial and 503B product lines.

This position offers the opportunity to work at an established, FDA-registered pharmaceutical company where your expertise contributes directly to drug development, manufacturing quality, and addressing critical drug shortages.

About McGuff

The McGuff family of companies includes

· McGuff Pharmaceuticals, Inc. (MPI) – focused on Abbreviated New Drug (ANDA) development, contract manufacturing, and CDMO services

· McGuff Outsourcing Solutions, Inc. (MOS) – A registered 503B Outsourcing facility focused on custom drug development, including products on the FDA Drug Shortage List

Both divisions are FDA-registered and recognized for a long-standing commitment to quality, compliance, and customer satisfaction.

Why Join McGuff

· 20+ year established pharmaceutical company with strong regulatory reputation

· Direct impact on drug shortage mitigation and patient care

· Leadership role with 4 direct reports and cross-functional influence

· Exposure to both development and commercial manufacturing environments

· Stable, privately held organization with long-term leadership focus

· Collaborative culture emphasizing employee development and accountability

Key Responsibilities

Hands on Analytical Testing & Operations (40%)

· Perform hands on testing of raw materials, in-process samples, finished goods, and stability samples

· Ensure accurate, timely, and compliant laboratory execution

· Oversee analytical testing at third party contract labs.

Stability Program Management (40%)

· Own and manage the stability program for both commercial and 503B product lines

· Develop and maintain stability protocols, storage conditions, and testing schedules

· Oversee sample management, data review, trending, and out-of-trend investigations

· Prepare stability summaries and technical reports in support of regulatory submissions

Method Development & Validation (10%)

· Develop, validate, and implement analytical methods (HPLC, UHPLC, TOC, , etc.)

· Support method transfer and compendial method verifications.

Quality Systems & Compliance (10%)

· Maintain compliance with cGMP and GLP requirements

· Support investigations, CAPA, and ongoing state of control

· Develop and maintain laboratory procedures and documentation

· Write/review laboratory OOS/OOT investigations.

Data Analysis & Reporting

· Apply statistical tools to support method validation and data evaluation

· Design and execute experimental studies

· Prepare technical reports and documentation

Qualifications

Required

· MS in Analytical Chemistry or related scientific discipline

· Minimum 3+ years of pharmaceutical analytical experience

· Strong hands-on expertise with HPLC/UHPLC,UV-Vis, TOC, FTIR, HIAC-9703+ or equivalent, Leak tester, KF and wet chemistry techniques.

· Experience in GMP/GLP-regulated environments

· Proven ability to lead technical work and mentor junior staff

Preferred

· Experience with method validation/compendial method verification technology transfer, and stability program management

· Experience supporting QC functions

Physical Requirements

· Ability to lift up to 50 pounds

· Ability to handle laboratory materials including cylinders and waste containers

· Work performed in a pharmaceutical laboratory environment

Compensation & Benefits

· Salary range flexible depending on experience and qualifications

· Comprehensive benefits package

· Opportunities for advancement

· Stable, full-time position with semi-flexible day shift schedule (Monday–Friday)

Location

Santa Ana / Costa Mesa, California

Please submit your resume to: ***email_hidden***