Supervisor, Chemistry - Nights

This role oversees testing activities for raw materials, in-process samples, finished products, stability samples, particulate testing, and plant water testing while ensuring compliance with approved methods, SOPs, cGMP requirements, data integrity standards, and regulatory expectations.

The Chemistry Supervisor leads and develops laboratory personnel through work assignment, prioritization of activities, training qualification oversight, coaching, mentoring and performance management.

Essential Duties and Responsibilities

• Provides leadership and oversight of Chemistry laboratory operations to ensure the timely, accurate, and compliant execution of analytical testing activities supporting manufacturing operations, product release, stability programs, customer requirements, and utility monitoring programs as applicable.
• Supervises laboratory personnel, including work assignment, training qualification oversight, coaching, performance management, employee development, and technical competency assessment.
• Ensures testing is performed in accordance with approved methods, specifications, SOPs, cGMP requirements, data integrity principles, and regulatory expectations.
• Provides technical leadership and subject matter expertise for analytical methods, laboratory instrumentation, troubleshooting activities, and resolution of complex technical issues.
• Supports and oversees analytical method transfers, method validation and verification activities, protocol execution, and implementation of new laboratory technologies and processes.
• Reviews and approves analytical data, laboratory documentation, calculations, and electronic records to ensure accuracy, completeness, and compliance with applicable procedures and regulatory requirements.
• Leads or oversees laboratory investigations, including deviations, problem reports, OOS, OOT, atypical results, CAPAs, and change controls, and ensures records are completed accurately and within established timelines.
• Applies risk assessment and root cause analysis tools to support investigations, corrective actions, and continuous improvement initiatives.
• Maintains laboratory inspection readiness and supports internal audits, customer audits, and regulatory inspections.
• Manages laboratory resources, testing priorities, instrumentation utilization, and workload planning to support operational and customer commitments.
• Monitors and trends laboratory performance metrics and identifies opportunities to improve compliance, efficiency, reliability, and quality.
• Identifies, communicates, and escalates quality, compliance, safety, data integrity, and operational risks as appropriate.
• Participates in and leads cross-functional projects and continuous improvement initiatives.

Education and Experience

• Bachelor’s degree in Chemistry or relevant physical science or life science discipline
• Minimum of three (3) years of relevant experience in pharmaceutical manufacturing or related industry, required
• Minimum of five (5) years of experience in pharmaceutical, biotechnology or other regulated laboratory environment, preferred
• Minimum of two (2) years of experience in a laboratory leadership or supervisory role
• Experience performing, reviewing, and interpreting analytical testing and laboratory data
• Experience with cGMP regulations, data integrity requirements, laboratory investigations, deviations, CAPAs, and change controls
• Experience with analytical instrumentation and laboratory systems commonly used in pharmaceutical testing environments
• Experience supporting internal audits, customer audits, and regulatory inspections

Supervisory Responsibilities

This position directly supervises Chemistry laboratory personnel and is responsible for the overall leadership, performance, and compliance of the department. Responsibilities include assigning and prioritizing work, managing staffing and laboratory resources, monitoring workload, and ensuring testing activities are executed in accordance with approved procedures, cGMP requirements, data integrity principles, and established timelines.

The Chemistry Supervisor is responsible for employee development and performance management, including onboarding, training qualification oversight, coaching, mentoring, performance evaluations, corrective feedback, disciplinary actions, and participation in hiring decisions.

Language Skills

The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities

• Leads with integrity and respect
• Provides guidance, coaching, and mentorship to team members
• Demonstrates business acumen
• Fosters a collaborative and positive work environment
• Champions change
• Coaches and Develops
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening