Associate Director, Production

NCBioImpact; Raleigh (NC); On-site; USD 170,000 - 180,000; Full time

Benefits offered by this job

Competitive PTO

Bonus program

Long-Term Incentive Plan

401(k) and Profit-Sharing

Health, Dental, Vision, Life and Dis1

Job summary

Indivior in Raleigh seeks Associate Director, Production to guide the drug product value stream, collaborate with SLT, and uphold safety, quality and cost targets. You will plan schedules, coordinate manufacturing activities, and drive continuous improvement using Lean, Six Sigma and TPM practices while ensuring on-time delivery and regulatory compliance across the site.

This leadership role frames site strategy, mentors managers, and partners with QA, regulatory affairs, and external partners

Qualifications

• Bachelor of Science in life science or engineering; postgraduate degree preferred.
• Minimum 10 years in a regulated industry with supervisory experience.
• Experience with aseptic processing and prefilled syringe production.
• Proficient in establishing performance standards and supervising direct/indirect reports.
• Knowledge of product cost accounting and delivering drug product on schedule and at budget.
• Ability to perform and coach systematic root cause analysis and implement countermeasures.
• Strong Lean Six Sigma, 5S and TPM experience.
• Excellent communication and leadership across functions.

Responsibilities

• Contribute to site SLT driving strategy and culture, collaborating with cross-functional leaders on continuous improvement initiatives.
• Accountable for KPIs including machine and labor efficiencies; guide department leaders to meet scorecard objectives.
• Lead Lean and Six Sigma projects to drive process improvements and operational excellence.
• Coordinate staffing, training, and development to build a capable production team.
• Ensure OSHA and environmental regulations are followed and production remains inspection ready.
• Support capacity planning and scheduling optimization to meet internal and external delivery deadlines.

Skills

Lean Six Sigma

Leadership

Project management

Communication

Problem solving

Regulatory compliance

Quality mindset

Education

Bachelor of Science in life science or engineering

Postgraduate degree preferred

Job description

Associate Director, Production

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.

POSITION OVERVIEW

The Associate Director, Production is a key member of the Indivior Raleigh site Senior Leadership Team (SLT), reporting to the Site Director of Operations. The Associate Director, Production is responsible for the direction and management of the drug product value stream within operations and is accountable for improvement of key performance indicators related to safety, quality, delivery, and cost. This role prepares operation schedules and coordinates manufacturing activities to ensure production and quality meet specifications.

HOW YOU’LL MAKE AN IMPACT

• Contribute to site as integral part of SLT driving strategy and culture, including collaboration with cross-functional leaders to set continuous improvement initiatives to drive operational excellence
• Accountable for key performance metrics including machine and labor efficiencies and provides guidance to departmental leaders to ensure scorecard objectives and KPI's are met and ensure that all customer/production delivery deadlines are adhered to
• Drive and lead the use of Lean and Six Sigma tools and techniques in problem solving and process improvement activities
• Collaborate with cross-functional leaders to set continuous improvement initiatives for operational excellence and instill, promote, and drive continuous improvement culture within existing businesses and establish appropriate structures and systems to deliver value to the customer and drive operational excellence
• Support site leader in managing capacity and participates in scheduling optimization to meet internal and external customer on-time delivery demands as well as defines departmental objectives in line with business goals

• Institute and ensure implementation of training programs to ensure personnel are proficient in performance of assigned duties. Provide guidance on staffing, training & development, employee relations and performance management to develop and enhance the salaried and hourly production team, working closely with direct reports
• Implement engagement plans & initiatives to motivate workers towards achieving established goals. Routinely evaluate and review employee performance
• Work with Technical / Project Management teams to execute drug product technical transfer according to plans as scheduled and on time
• Ensure plant follows OSHA and local, state and federal environmental regulations
• Ensure that value stream in its entirety is inspection ready at all times as well as other duties as assigned by Site Leadership
• Other responsibilities, as assigned

WHAT YOU’LL BRING

• Bachelor of Science degree in life science or engineering discipline. Post graduate degree is preferred.
• Minimum ten (10) years of experience in a regulated industry, with demonstrated performance in a supervisory position and proficient in managing daily improvement (MDI) facilitation and visual factory concepts in a cGMP/FDA regulated industry
• Experience with aseptic processing and prefilled syringe production
• Proficiency in establishing performance standards and monitoring performance of direct and indirect reports as well as ability to teach others to do the same
• Knowledge of product cost accounting and delivering drug product on schedule and at budget
• Ability to perform and coach systematic root cause analysis and implementation of effective countermeasures
• Demonstrated proficiency in driving the 5S process and culture in the plant
• Practical application of TPM concepts to include autonomous maintenance and performance monitoring through OEE
• Strong verbal and written skills; exceptional attention to details and documentation. Ability to choose a type of communication that is most effective in each situation. Such competency empowers individuals to achieve the goals of any communication in a manner that is best suited for all parties involved.
• Demonstrated ability to work effectively in a team and as a leader including appreciation of cultural differences and diversity in the workplace, ability to build positive relationships with others and conduct negotiations to establish win/win solutions
• Experience with recruitment, interviewing and hiring appropriate staffing levels
• Ability to facilitate continuous improvement events (value stream mapping, SMED, kaizen) a plus
• Strong interpersonal skills and ability to communicate clearly to all levels of the business, via concise written or oral summaries to senior management.
• Experience in production operations a plus.
• Influencing skills in areas with no direct reporting authority.
• Strong planning and organization skills.
• Auditing skills, and appropriate qualifications in auditing is an advantage.
• Motivated by delivering high quality patient treatments in the arena of addiction.
• Proficient in English. However, fluency in other languages is advantageous.

HOW WE INVEST IN OUR PEOPLE

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

Starting Salary: $170,000- $180,000 USD

*Note actual salary is based on qualifications and experience

• Competitive PTO plus company closure from December 24th- 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

OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior.

Employee Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

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.

Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.