Process Development Intern

Technical Transfer Services Greenville, North Carolina


Description

Position Overview

This is an entry level, part-time position that will assist in project execution.

 

Key Responsibility Areas

  • Project Support:  Provide support for commercial transfers, technology transfers, and scale up studies as specified by technical transfer leads and other Manufacturing, Science, and Technology personnel
  • Risk Mitigation and Compliance:  Aid in the minimization of potential for issues or impact of issues during the manufacturing process transfer

 

Specific Responsibilities

Responsibilities include, but are not limited to:

  • With close supervision, support and assist in optimization of equipment and manufacturing processes
  • With close supervision, assist in the development of report, batch records, protocols, and timelines
  • Support documentation associated with engineering and feasibility batches
  • Research existing documents, and perform data entry and data analysis
  • Execute experiment documentation such as protocols and manufacturing records
  • With close supervision, assemble, disassemble, and clean and store equipment
  • Ensure that all work is accurate, precise, properly documented, and compliant with SOPs and FDA cGMP guidelines

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
  • Attention to Detail:  Ensure information is complete and accurate; follows up with others to ensure that agreements and commitments have been fulfilled.
  • 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
  • Initiative:  Identify opportunities and issues, and proactively acts and follows through on work activities to capitalize or resolve them
  • 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
  • Problem Solving:  Builds a logical approach to address problems or opportunities or manage the situation at hand by drawing on one’s knowledge and experience base, and calling on other references and resources as necessary

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


Qualifications

  • Current or recent enrollment in an undergraduate or graduate degree program (e.g. Chemistry, Chemical Engineering, Mechanical Engineering, or Pharmaceutical Science)
  • Proficient in Microsoft Word, Excel, and PowerPoint
  • Must be located within 50 miles of the Greenville, North Carolina, site during internship to be considered

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.