Production Supervisor - 2nd Shift

Indivior; Raleigh (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Competitive PTO

401(k) with company match

Tuition reimbursement

Wellness programs

Job summary

Indivior is seeking a Production Supervisor for the 2nd shift in Raleigh, North Carolina. The supervisor will oversee the safety and quality of production in both aseptic and non-aseptic areas while coordinating all aspects of operations.

The ideal candidate will possess at least five years of experience in a regulated industry, strong leadership abilities, and skills in cGMP manufacturing. Benefits include competitive PTO, a bonus program, and comprehensive health coverage.

Qualifications

• Minimum five years of experience in a regulated industry.
• Minimum three years related experience in supervision.
• Pre-filled syringe experience preferred.

Responsibilities

• Oversee compliance and establish systems for continuous improvement.
• Manage day-to-day activities in the operational area.
• Lead cross-functional teams for production issues.

Skills

Leadership and supervisory skills

Analytical reasoning

Problem-solving

Strong math skills

Computer skills

Experience in cGMP manufacturing

Job description

Company Overview

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence‑based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

Production Supervisor – 2nd Shift

Position Overview

The Production Supervisor role is responsible for safety, quality and performance of the prep, compounding filling area and inspection area. The role will work in both aseptic and non‑aseptic areas, and will plan and coordinate all aspects of the production area.

Responsibilities

• Oversee that operational areas are in cGMP compliance, and responsible for establishing systems that support the continuous improvement of procedures to heighten quality.
• Ensure the timely and accurate documentation and closeout of batch records.
• Manage the day‑to‑day activities of the operational area.
• Develop and review SOPs pertaining to Prep, Compounding and Filling.
• Drive continued improvement in operational areas.
• Trend and take appropriate actions to agreed KPI.
• People development and management.

Qualifications

• Demonstrated leadership and supervisory skills.
• Minimum five (5) years of experience in a regulated industry.
• Minimum three (3) years related experience supervision is preferred.
• Experience in cGMP manufacturing or clean room production environment is preferred.
• Pre‑filled syringe experience preferred.
• Ability to apply analytical reasoning and root cause analysis to solve problems.
• Strong math and calculating skills.
• Computer skills.
• Ability to read, understand, interpret and implement technical writing and instruction, and have exceptional ability to solve problems in a fast‑paced environment.
• Get certified on all the curriculums in the operational area: 1) understand the process and help to improve it; 2) help cover breaks, vacancies, etc.
• Lead cross‑functional teams to solve urgent production issues, implement improvements.
• Work with operational team to improve KPIs or other trends/tasks independently.
• Independently investigate pharmaceutical operations and facility nonconformances, identifying any deviations from standards. This includes clearly defining problems, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, SOPs and supply‑chain business practices.
• Review supporting documentation including batch documentation, ancillary documentation, test results/CoAs, product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents.
• Assist with deviation/CAPA investigation and understand the process so, if needed, to take over and finalize an investigation/CAPA.
• Assist with revision to SOPs pertaining as an SME in the operating area.
• Be the SME during internal/external audits, lead presentations and present to the auditing team.
• Lead Tier 1 meeting and participate in Tier 2 meeting.
• Build a self‑sufficient team that can work independently and have very little overview.
• Cover for peers and manager if needed.

Benefits

• Competitive PTO plus company closure from December 24th to January 1st.
• Eligible to participate in Indivior’s bonus program, based on company and individual performance.
• Eligible to receive a yearly grant as part of Indivior’s Long‑Term Incentive Plan.
• 401(k) and Profit‑Sharing Plan – company match.
• U.S. Employee Stock Purchase Plan – 15% discount.
• Comprehensive medical, dental, vision, life and disability coverage.
• Health, dependent‑care and limited‑purpose flex spending and HSA options.
• Adoption assistance.
• Tuition reimbursement.
• Concierge/personal assistance services.
• Voluntary benefits including legal, pet insurance and critical illness coverage.
• Wellness programs as well as other discounts and perks.

Equal Employment Opportunity

EOE/Minorities/Females/Vet/Disabled are encouraged to apply! The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.