Analytical Chemistry Manager

McGuff Pharmaceuticals, Inc. is seeking an Analytical Chemistry Manager to lead and advance our analytical laboratory operations supporting sterile and non-sterile drug manufacturing. This is a senior-level, high-impact role with direct supervisory responsibility (4 reports) and significant influence across product development, quality systems, regulatory compliance, and 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

Leadership & Laboratory Management

· Lead and supervise a team of 4 or more analytical chemists

· Ensure personnel are trained and qualified for essential lab functions

· Drive efficiency, reliability, and continuous improvement within the laboratory

Stability Program Management

· 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

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

· Support method transfer and compendial method verifications.

Analytical Testing & Operations

· Oversee and perform 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.

Quality Systems & Compliance

· 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.

Regulatory Support

· Serve as analytical chemistry SME for ANDA filings, 503B documentation, and other regulatory submissions

· Prepare and review analytical sections of regulatory submissions, including method descriptions, validation summaries, and stability data packages

· Support internal and external audits and regulatory agency inspections

Technical Leadership

· Serve as Subject Matter Expert (SME) for analytical chemistry

· Provide technical guidance to QA, QC, and cross-functional teams

· Support internal and external customer needs

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 or PhD in Chemistry or related scientific discipline

· Minimum 6 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

· Prior supervisory or team leadership experience

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

· Familiarity with LIMS, CDS, and statistical analysis tools

· Experience supporting regulatory submissions (ANDAs, 503B documentation)

· Experience supporting both QA and QC functions 

· Knowledge of Mass spectroscopy or Waters QDa detector.

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

Apply

Please submit your resume to: employment.MPI@mcguff.com