Pharmaceutical Manufacturing Specialist

Manufacturing Greenville, North Carolina


Description

Position Overview

This position has a primary focus on new technology and business moving into Commercial Manufacturing Operations as well as serves as a liaison with other functional teams to lead/support commercial manufacturing operations and cross-functional execution. This role provides on-the-floor oversight, direction and support to manufacturing personnel to ensure timeliness and accuracy in the completion of assigned work.  

The work schedule for this position is Monday through Thursday. There is potential for Friday scheduling depending on business needs.

Key Responsibility Areas

  • Equipment Maintenance:  Identify and resolve process and/or equipment failures; initiate appropriate action to prevent reoccurrence
  • New Technologies and Products:  Be a key resource in the introduction and integration of new technologies and equipment into the Commercial Manufacturing Operations team; serve as a point of contact for Tech Services, MCS Clients and internal resources for product transfers
  • Manufacturing Training:  Provide technical training for a specialized selection of manufacturing training protocols including, but not limited to, dispensing, compounding, compressing, encapsulating and tablet coating
  • Production Oversight:  Provide direction and assist team in the successful manufacturing of commercial, MCS and Tech Transfer batches; lead team in the set-up and change-over of processing equipment

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Frontline interface between the Commercial Manufacturing team, internal support teams as well as external clients to lead/support project work requiring cross-functional support
  • Assist in Commercial, Technical Transfer, Engineering and Development batches
  • Maintain the inventory system for raw materials components; train and assist others in the use of the inventory system
  • Assist in decisions on equipment selection, placement, and procedures to most effectively use equipment
  • Ensure manufacturing area and equipment are maintained in accordance with company and regulatory requirements
  • Recognize potential problems and provide input on corrective action(s), assist in completion of resolutions for issues in Commercial Manufacturing Operations
  • Identify and recommend opportunities for improved efficiencies, client service and teamwork within Commercial Manufacturing Operations
  • When necessary, assist in cleaning of equipment
  • Troubleshoot equipment, process issues and escalate problems that require QA or Maintenance involvement; provide leadership and support for the timeliness and accuracy in the completion of Commercial Manufacturing operations
  • Support and occasionally lead under supervision the scheduling and planning of client project work to ensure the highest levels of efficiency and quality standards are met

Key Competencies/Requirements

  • Accountability:  Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
  • Agility:  Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
  • Creativity:  Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
  • Empowerment:  Find opportunities to improve and extend their contribution to the organization and their teammates
  • Integrity:  Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas
  • Passion:  Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
  • Attention to Detail:  Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
  • Communication: Deliver clear, effective communication and takes responsibility for understanding others
  • Leadership:  Motivate others, share knowledge, drive high performing teams, show respect towards others and provide constructive feedback
  • Task Management:  Plan work well, maintain flexibility and facilitate change when needed while optimizing quality and productivity
  • Teamwork:  Work well with others while providing support and assistance to team members to help accomplish objectives

Qualifications

  • High school diploma or equivalent with at least 5 years of experience in pharmaceutical OSD manufacturing
  • Associate degree with at least 4 years of experience in pharmaceutical OSD manufacturing
  • Demonstrated proficiency in OSD manufacturing operations related to Dispensing, Granulation, Compressing/Encapsulation and Coating
  • Must have previous experience with inventory management systems and be able to learn QAD (inventory Management System) to assist in the timely start and completion of batches and documentation
  • Required to obtain internal forklift operation certification

Physical Requirements

  • Position requires the ability to lift 50 lbs unassisted, and push and pull in excess of 100 lbs
  • Majority of work day is performed while standing and walking
  • Requires the use of hands for simple grasping and fine manipulations
  • Ability to occasionally bend, stoop, twist, and have full range of motion in upper and lower extremities
  • Exposure to hazardous chemicals, other active chemical ingredients, dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments
  • Must be able to use a variety of tools, equipment, and machinery

Equal Employment Opportunity and Employment Eligibility 

Mayne Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  Mayne Pharma also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Mayne Pharma is an E-Verify employer.