Sr. Manager/Associate Director, Operations (On-site)

Purdue Pharma L.P.; Wilson (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company is seeking a Sr. Manager/Associate Director of Operations in Wilson, NC. The role focuses on overseeing manufacturing processes, ensuring regulatory compliance and optimizing production standards. With a minimum of 10 years of experience in the field, the candidate will drive strategic objectives while fostering a collaborative and safe work environment.

Qualifications

• Minimum 10 years of experience in a pharmaceutical production environment.
• 3-5 years of direct management experience.
• Experience with Operational Excellence programs.

Responsibilities

• Ensure compliance with FDA and cGMP regulations.
• Coordinate scheduling and daily operations of manufacturing.
• Promote a safety-focused work environment.

Skills

Leadership

Problem Solving

Compliance Management

Education

Degree in a related technical field

Tools

Lean Manufacturing techniques

OEE Tools

Job description

Sr. Manager/Associate Director, Operations (On-site)

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Sr. Manager/Associate Director, Operations (On-site)

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Join to apply for the Sr. Manager/Associate Director, Operations (On-site) role at Purdue Pharma L.P.

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.

We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.

We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue’s Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.

At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!

Job Summary

Provides technical oversight and coordination of manufacturing and/or packaging processes for Purdue Pharmaceuticals, LP in Wilson, N.C. This position can execute processing assignments independent of direct supervision and providing direct support in the achievement of facility goals and objectives.

The incumbent is responsible for the manufacturing and/or packaging of solid dose products in compliance with cGMP, SOPs, FDA, and DEA regulations and has direct responsibility for producing to the production plan to optimize schedule adherence and reduce cycle times. This position is responsible for developing and maintaining efficient and effective production processes using “best-in-class” tools such as OEE and Lean Manufacturing techniques.

In addition, the position is responsible for promoting and fostering a work environment that is safe and conducive to employee development and where Purdue’s values are demonstrated and practiced. The incumbent is responsible for supporting the operations cross-training program for developing well-trained, flexible, cross functional teams.

Primary Responsibilities

• Ensure all solid dose pharmaceutical processes are executed in compliance with all FDA, cGMPs and DEA requirements.
• Coordinate the daily operation of solid dose manufacturing and/or packaging, which includes the scheduling of production and the assignment of personnel, to meet production requirements and organizational goals.
• Reinforce proper compliance with cGMP, SOPs and FDA guidelines to maintain control requirements. Control the manufacturing and packaging of narcotic production activities and troubleshoot, identify problems, and make well informed decisions.
• Communicate and motivate employees by making clear how their work objectives are directly linked to Purdue’s overall business goals and objectives. Also communicate strategic expectations throughout the organization and translate those expectations into specific work objectives.
• Coordinate with other support departments and expedite material to ensure that production schedules are achieved. Communicate with Quality Assurance and Quality Control to ensure objectives and criteria are clear and identifiable to maintain cGMP.
• Partner with Quality Assurance (QA) department to effectively document quality events and draft investigations. Provide technical evaluations and CAPA’s as needed to assist in identifying true root cause analysis and corrective/preventative actions.
• Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
• Provide technical expertise in solving production/process problems and is responsible for ensuring adherence to sound documentation practices.
• Perform other duties as assigned.
  
  

Education And Experience Requirements

A minimum of 10 years pharmaceutical experience required in a production environment (preferably in solid dose production) and a degree in a related technical field; 3-5 years of direct management experience and demonstrated experience leading teams and cross-functional projects. Preferred experience in initiating and/or directing Operational Excellence programs within a dynamic team setting.

Necessary Knowledge, Skills, And Abilities

Incumbent must have direct experience in areas within the Department. Process areas are: Packaging, Manufacturing - Granulation (top spray, mixer/granulator/fluid bed dryer by solvent or aqueous), Compressing (single or double-sided press), Coating (solvent or aqueous), Extrusion, and Blending.

Incumbent must have the ability to work in a cross-functional team setting to solve problems and demonstrated ability to translate organization goals into team objectives.

Supervisor Responsibilities (if Applicable)

The Senior Manager is directly responsible for all solid dose packaging and/or manufacturing processes and will oversee daily operations. Will have direct management responsibilities for Supervisors and Managers of the process areas.

Physical and Environmental

• Wear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator) as needed.
• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax or other specialized equipment used in an office setting.
• Individual may move various items (i.e boxes, carts, files, etc) by hand or manual hand carts.
• Must be able to work a 10.5 hour per day/4-day work week; 40 hours per week.
  
  

Additional Information

Relocation is not offered for this position.

Purdue Pharma does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma.

Minimum required education, experience, knowledge, skills and abilities for Senior Manager Operations are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)
  
  

We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Talent Acquisition team at [e-mail]. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.

The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.

Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company’s internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

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