Supervisor, Chemistry - Nights

Summary: The Chemistry Supervisor provides leadership and oversight of daily laboratory operations to ensure the timely, accurate, and compliant execution of analytical testing supporting manufacturing operations, product release, stability programs, and customer requirements. 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. This role manages laboratory resources and testing priorities, reviews analytical data and laboratory documentation, oversees investigations, corrective actions and problem-solving activities and collaborates with cross-functional teams to achieve operational objectives. The position is responsible for maintaining laboratory inspection readiness, promoting a culture of safety, quality, compliance, and continuous improvement and escalating quality, compliance safety, data integrity and operational risks as appropriate.

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. Read/interpret SOPs to ensure compliance Maintain up to date trainings Other duties as assigned

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. The supervisor ensures personnel maintain required training, technical competency, and qualification status necessary to perform assigned responsibilities. This role provides technical and operational leadership for laboratory activities, supports the resolution of complex analytical issues, and ensures investigations, deviations, CAPAs, change controls, and other quality system records are completed accurately, thoroughly, and in a timely manner. The supervisor is responsible for identifying, communicating, and escalating quality, compliance, safety, data integrity, and operational risks when appropriate. The Chemistry Supervisor fosters a culture of accountability, continuous improvement, safety, and regulatory compliance while maintaining inspection readiness and supporting departmental and organizational objectives. The position is accountable for promoting effective communication, collaboration, and a positive work environment that supports employee engagement, customer satisfaction, and business success.

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:

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The essential physical demands will vary for each Curia position. All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure