Director of GMP Analytical, Pharmaceutical Analytical Sciences

Job Overview

The Pharmaceutical Analytical Sciences team is seeking a GMP Analytical Director based in Rahway, NJ. The director will lead a team of scientists supporting GMP analytical activities for a small molecule clinical portfolio, including method validation, clinical release, and stability testing for drug substance and drug product.

Responsibilities

• Provide technical and compliance oversight on laboratory investigations and deviations, including root cause analysis and corrective/preventive actions.
• Review and approve GMP data, release specifications, analytical reports, certificates of analysis, and SOPs.
• Serve as analytical lead during internal and external compliance audits, ensuring inspection readiness.
• Drive operational excellence and process improvements within the laboratory.
• Recruit, onboard, and develop employees, fostering talent growth.
• Plan proactive resourcing, conduct risk assessments, and manage the laboratory budget.
• Collaborate with senior management and pharmaceutical analytical leadership on strategic and cultural initiatives.

Education and Experience

• BS in Chemistry or related science with at least 12 years of industry experience (pharmaceutical drug substance or product development).
• MS in Chemistry or related science with at least 10 years of industry experience.
• Ph.D. in Chemistry or related science with at least 8 years of industry experience.

Required Skills

• Proven leadership in a GMP analytical laboratory.
• Coaching and talent development expertise.
• Excellent written and verbal communication.
• Creativity, interpersonal, and collaborative abilities.
• Strong project management and on‑time, first‑time result delivery.
• Deep knowledge of analytical methods such as liquid chromatography, spectroscopy, titration, and dissolution.
• Compliance oversight, inspection readiness, and regulatory knowledge (cGMP, ICH, FDA guidelines).
• Risk analysis and mitigation strategy (REMS).
• Process Analytical Technology (PAT) and pharmaceutical project management.

Preferred Skills

• Experience with Biologics License Applications (BLA).

Benefits

Salary range: $173,200 – $272,600. Eligible for an annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.

EEO Statement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.