Microbiology Manager Jobs in Raleigh, NC (NOW HIRING)

TITLE:

WHO WE ARE

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 forOUD,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 toexpandits heritage in thiscategory. Headquartered in the United States in Richmond, VA,Indivior employs approximately 800 individuals globally.

POSITION OVERVIEW

The Environmental Monitoring (EM) Supervisor is responsible for supervising the activities of Environmental Monitoring technicians and ensuring EM production coverage on all shifts is provided. Responsible for effectively hiring, developing, coaching, counseling, managing and motivating the EM staff. The number of direct reports fluctuates with the needs of the business. Responsible for the timely and accurate completion of required environmental samples and collection of water and other site utility samples.

Assures compliance to cGMP and Indivior specifications. Identifies areas for validation and/or improvement and develops protocols for same. Inform Senior Manager of QC of departmental activities and product related events. This position may represent the QC department at meetings and provides guidance in the absence of the Senior Manager of QC.

HOW YOU'LL MAKE AN IMPACT

The responsibilities of this role include, but are not limited to, the following:

• Supervises daily activities of EM technicians. Assures that job activity deadlines are met on a timely basis. Ensures daily quality concerns and questions are being adequately addressed by department personnel.
• Ensures system for monitoring and trending environmental data is up to date and data is approved
• Assures proper and timely collection of environmental and site utility samples
• Participates and serves as the EM representative during internal and regulatory audits
• Creates EM summary reports to support site and product filings
• Instructs the new employee gowning classes
• Instructs the Aseptic Process Area (APA) gowning class and approves new employees to start APA qualification
• Ensures all employees that enter the APA are gown qualified / requalified and participate in annual media fills
• Assess planned repair work to be performed in the classified areas and completes the QC Approval of CWOs for the work to be performed
• Ensures the review and approval of EM data is completed and delivered to MQA to support the weekly System Release process
• Hires and oversees the training of department personnel. Assures steps are being taken to maintain positive personnel morale and development. Conducts performance evaluations
• Assures execution of monitoring and testing programs to assess the microbiology quality parameters of in-process, environmental systems and effectiveness of production processes
• Establishes goals for the timely release of product and performance of projects. Monitors performance of the group against the goals to identify and implement needed corrective action.
• Ensures that product or an environmental system not meeting specifications and limits is promptly investigated
• Identifies possible source and corrective action needed and evaluates the impact upon the lot
• Identifies significant adverse quality trends by preparing and analyzing summary reports
• Addresses quality control test results, microbial profiles of environmental systems.
• Generates and updates Standard Operating Procedures
• Maintains current knowledge of cGMPs and regulatory issues/guidelines
• Assures department is equipped with functional, calibrated equipment and necessary supplies
• Supervises investigations of out of specification results and environmental excursions
• Ensures adequate evaluation of new product processes
• Represents the department in cross functional teams and meetings
• Performs other duties and projects as assigned by management

WHAT YOU'LL BRING

• Bachelor's degree in microbiology, biological sciences or related field required
• Requires three to five years of progressive laboratory/environmental monitoring responsibility in support of pharmaceutical manufacturing or equivalent related industrial or clinical experience
• Experience in aseptic processing is preferred
• Must be knowledgeable of quality control testing methods, validation techniques and concepts of microbiology
• Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience in pharmaceutical applications
• Supervisory experience preferred, but candidate must have held some type of leadership role
• Demonstrated leadership and supervisory skills
• Excellent verbal and written communication skills are essential

PHYSICAL REQUIREMENTS

• Position is exposed to a number of environments, office, lab, outside, plant floor, etc. The role requires continuous computer use and typing, along with routine walking between offices, laboratories, and operational areas. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally. Personnel engaged in the manufacture, processing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

HOW WE INVEST IN OUR PEOPLE

Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company. The following benefits are provided by Indivior, subject to eligibility requirements.

Starting Salary: $88,000-$95,731 USD

*Note actual salary is based on qualifications and experience

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:

• Competitive PTO plus company closure from December 24th- January 1st
• Eligible to participate in Indivior's bonus program, based on company and individual performance

• 401(k) and Profit-Sharing Plan: Company match of 75% on your first 6% of contributions and profit-sharing contribution equal to 4% of your eligible pay
• Annual Equity for All program and 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

• Adoptionassistance

• Tuition reimbursement

• Concierge/personalassistanceservices

• 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 tomaintaininga 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/Disabledare encouraged to apply!

The duties and responsibilitiesidentifiedin this position description are considered essential but are not limited to only those outlined.Theemployeemay perform other functions that may be assigned.Managementretainsthe discretion to add or change the duties of thisposition at any time.

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