Senior Development Scientist

Pharmaceutical Development Greenville, North Carolina


Description

Position Overview

This position leads and supports formulation and process development activities while serving 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

  • People Development:  Lead in the development of a culture, and supporting systems, to drive open communication, participation, and idea-sharing in order to build an engaged team, advances and models Mayne Pharma values and leadership commitments
  • Pharmaceutical Development:  Manage formulation development activities to develop stable and robust formulations, using Quality by Design Principles
  • Process Optimization:  Identify and recommend opportunities for improved efficiencies and teamwork across the Pharmaceutical Development group
  • Scientific Excellence:  Design and execute experiments in support of potential new technological offerings as well as participate or support research articles and publications

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Independently design, coordinate, and execute all product development activities including material characterization, excipient selection, prototype manufacture, equipment selection, generation of batch records, scale-up, QbD, and registration batch activities
  • Work closely with analytical scientists, project management, quality and commercial operations to ensure that formulation and process development are appropriate and timely
  • Write all the required documentations such as batch records, product development reports, risk assessments, and campaign summaries
  • Communicate effectively with internal staff, clients, and external vendors
  • Responsible for GMP compliance in formulation and process development
  • Support and contribute to qualification of facility and equipment
  • Coordinate with logistics and scheduling groups to help ensure that an adequate inventory of raw materials is maintained at all times
  • Maintain competence and training documentation for relevant equipment and processes

Key Competencies/Requirements

  • Agile & Flexible: Leads and embraces change. Fosters innovation by challenging the status quo and initiating new ways of working.
  • Celebrator: Embraces a culture of action. Sets challenges and achieves results. Celebrates and rewards achievements of team members.
  • Communicator/Collaborator: Builds shared meaning through open and respectful communication. Engages stakeholders in pertinent conversations, and creates an atmosphere that is inclusive and consultative.
  • Leads Self: Maximizes personal potential by focusing on ongoing professional growth. Takes initiative, honors promises, and acts with courage.
  • People Developer: Empowers, inspires, and challenges team members. Fosters high performance and development.
  • Purpose Driven: Drives vision and purpose by creating and contributing to strategic direction. Aligns priorities to organizational goals.
  • Solutions Focused: Solves problems once and simplifies issues. Makes problems visible and acts decisively.
  • Team Builder: Builds and optimizes a high performing team. Creates a sense of belonging and connectivity among team members.
  • Conflict Resolution:  Bring substantial conflicts and disagreements into the open and attempt to manage them collaboratively, building consensus, keeping the best interests of the organization in mind, not only one's own interest
  • Leadership:  Motivate others, share knowledge, drive high performing teams, show respect towards others and provide constructive feedback

 Qualifications

  • Ph.D. in Pharmaceutical Science or related field or Pharm.D. with at least 4 years of industrial product development experience
  • Master’s degree in pharmaceutical science, chemistry, or related science with at least 5 years of industrial pharmaceutical experience
  • Bachelor’s degree in pharmaceutical science, chemistry, engineering or related science with at least 6 years of industrial pharmaceutical experience

Physical Requirements

  • Some exposure to hazardous chemicals and other active chemical ingredients
  • Capacity to handle and manipulate objects using hands and arms
  • 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.