Group Leader, Research and Development

Mayne Pharma - Greenville, NC (30+ days ago)3.0


Position Overview

This position is responsible for leading an analytical team in day-to-day activities in support of ANDA development projects as well as to develop and coach team members in their career aspirations.

Key Responsibility Areas

ANDA Submissions: Author specifications, methods, validation documents and submission-ready documents for ANDA submissions
People Development: Ensure the career growth development of assigned team members by providing on-the-job training, mentoring and guidance
People Leadership: Lead in the development of a culture, and supporting systems, to drive open communication, participation and intra/inter-departmental idea-sharing in order to build an engaged team; advance and model Mayne Pharma values and leadership commitments while ensuring the highest levels of quality, compliance and integrity are adhered to in all interactions
Quality: Ensure the quality of work, products, and services as a first priority; comply with or exceed or exceed all regulatory and cGMP compliance standards as well as ensure accuracy and analyses as it relates to right first-time measures; ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
Specific Responsibilities

Responsibilities include, but are not limited to:
Direct oversight of development projects, which involves supporting multiple concurrent development projects and recommending approaches to analytical strategies and overall project success; propose specifications for tests; develop tests and methods; solve problems with methods, instruments, or processes; interpret data to draw conclusions and provide recommendations
Oversight of timesheet review and the development of work planning and scheduling
Regularly meet and communicate with department management in the development of best practice standards, identification of training needs and optimization of resource utilization
Review and approve COAs, Analytical Reports and stability packets
Works closely with Program Management, Pharmaceutical Development, Quality Assurance, Quality Control, Regulatory Affairs, CMOs and API suppliers to meet assigned project tasks and deliver a quality ANDA submission
Proficient in data review of Empower datafiles
Participate in cross-functional teams
Key Competencies/Requirements

Accountability: Assumes responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others.
Agility: Responds positively to change, embracing and using new practices or values to accomplish goals and solve problems.
Creativity: Explores and advances opportunities to develop novel solutions and approaches to the improvement of processes and services.
Empowerment: Finds opportunities to improve and extend their contribution to the organization and their teammates.
Integrity: Demonstrates the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas.
Passion: Evidences passion for the organization, our people, and the difference we make daily in improving the lives and health of people.
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
Team Development: Foster team environment, invest in team members and peers by inclusion and listening, recognizing employees effectively, and demonstrating trust
Qualifications

BS or BA degree in science with ten years of professional experience in pharmaceutical analytical chemistry
Master’s Degree in science with eight years of professional experience in pharmaceutical analytical chemistry
PhD in science with six years of professional experience in pharmaceutical analytical chemistry
Minimum of three years of experience leading and managing a team of analytical chemists
Physical Requirements

Some exposure to hazardous chemicals and other active chemical ingredients
Requires the use of hands for simple grasping and fine manipulations
Some exposure to hazardous chemicals and other active chemical ingredients
General Statement

Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.