Supervisor, Production

About the role

This position is responsible for the safety, quality, and performance of the prep, compounding, and filling area within a cGMP manufacturing environment.

Responsibilities

• Oversee operational areas to ensure cGMP compliance and establish systems that support continuous improvement of procedures to enhance quality.
• Ensure timely and accurate documentation and closeout of batch records.
• Manage day-to-day activities of the operational area.
• Develop and review SOPs pertaining to Prep, Compounding, and Filling.
• Drive continuous improvement in the operational area, trend KPIs, and take appropriate actions.
• Get certified on all curriculums in the operational area to understand and improve processes.
• Cover shifts during breaks, vacancies, and other absences.
• Lead cross-functional teams to resolve urgent production issues and implement improvements.
• Work with the operational team to improve KPIs or other trends/tasks independently.
• Investigate pharmaceutical operations and facility nonconformances, identifying deviations from standards, conducting root cause analysis, and determining solutions.
• Review supporting documentation including batch records, test results, CoAs, product specifications, training records, SOPs, calibration records, and validation protocols.
• Assist with deviation/CAPA investigations and revisions to SOPs as a subject matter expert (SME).
• Serve as the SME during internal and external audits, leading presentations for the auditing team.
• Lead Tier 1 meetings and participate in Tier 2 meetings.
• Build a self-sufficient team that requires minimal oversight.
• Cover for peers and managers as needed.

Requirements

• Demonstrated leadership and supervisory skills.
• Minimum five (5) years of experience in a regulated industry.
• Minimum three (3) years of related supervisory experience preferred.
• Experience in cGMP manufacturing or clean room production environment preferred.
• Ability to apply analytical reasoning and root cause analysis to solve problems.
• Strong math and calculating skills.
• Proficiency in computer skills.
• Ability to read, understand, interpret, and implement technical writing and instructions in a fast-paced environment.

Benefits

• Starting salary: $88,000–$100,000 USD (based on qualifications and experience).
• Competitive PTO plus company closure from December 24th to January 1st.
• Eligibility to participate in Indivior’s bonus program, based on company and individual performance.
• Eligibility to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan.
• 401(k) and Profit-Sharing Plan with company match.
• U.S. Employee Stock Purchase Plan with a 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 and other discounts and perks.