Development Scientist I

Pharmaceutical Development Greenville, North Carolina


Description

Position Overview

This position serves as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities.  This role is responsible for supporting these activities in the areas of supervision, process development, clinical trial batch manufacturing, packing and documentation.

Key Responsibility Areas

  • Scientific Excellence: Design and execute experiments in support of potential new technological offerings to our client base as well as participate or support research articles and publications
  • People Leadership:  Develop a continuous improvement culture whereby employees are coached and mentored to be change leaders; participations and intra/inter-departmental idea sharing in order to build an engaged team; advance and model Mayne Pharma values and leadership commitments; ensure that the highest level of quality, compliance, and integrity are adhered to in all interactions
  • Program Management: Design, coordinate, develop and execute development and CTM projects and activities ensuring that tasks are appropriately prioritized and completed according to deadlines

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Independently design and execute experiments
  • Interpret data and make sound recommendations based on data
  • Solve formulation and process problems
  • Author SOP’s, IQ/OQ/PQ documents, development and technical reports, and CMC sections for regulatory submissions
  • Maintain competency and training for relevant processes and equipment
  • Ensure that all work is accurate, precise, properly documented, within GMP requirements
  • Organize multiple project responsibilities to ensure tasks are appropriately prioritized and executed on time
  • Design, coordinate, and execute development and CTM activities, including formulation, data interpretation, equipment selection, generation of batch records and other appropriate documentation, and problem solving exercises
  • Ongoing communication with clients, internal support groups, resources, vendors and staff
  • Supervise 1-3 staff and ensure direct reports are adequately trained and actively engaged in departmental and corporate objectives

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
  • Communication:  Deliver clear, effective communication and assume responsibility for understanding others
  • Interpersonal:  Develop and maintain effective relationships with others; relate well to people from varied backgrounds and in different situations; show understanding, courtesy, tact, empathy, concern, and politeness
  • Task Management:  Strong organizational skills, ability to define, delineate roles and responsibilities effectively; plan well, flexible and able to facilitate change, optimize quality and productivity as projects progress

Qualifications

  • Bachelor’s degree in pharmaceutical science, chemistry, engineering, or related science with a minimum 3 years of industrial pharmaceutical experience
  • Master’s degree in pharmaceutical science or chemistry or related science with a minimum 2 years of industrial pharmaceutical experience
  • Ph.D. in Pharmaceutical Science or related field or Pharm.D.

Physical Requirements

  • Some exposure to hazardous chemicals and other active chemical ingredients
  • Position requires the capacity to handle and manipulate objects using hands and arms.
  • Requires ability to occasionally lift items in excess of 50 pounds

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.