Senior Development Scientist

Mayne Pharma Group Limited Greenville , NC 27833

Posted 2 months ago

Position Overview

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

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Responsible for all formulation and process development of several ongoing projects including project management and customer contact

  • Responsible for GMP compliance in formulation and process development

  • Responsible for assisting with planning and operating within a budget for the pharmaceutical area

  • Work directly with customers and potential customers to agree on development approaches and scope of work

  • Independently assist manufacturing group with batch manufacture and packaging/labeling, including set-up and cleaning

  • Independently assist in solving formulation and process problems

  • Independently assist with the writing of batch records, SOPs, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed

  • Ensure that all work is accurate, precise, properly documented and, when appropriate, performed within GMP guidelines

  • Maintain competence and training documentation for relevant equipment and processes

Qualifications

  • Bachelor's degree in Pharmacy, Chemistry, Biology or related field with 8 or more years experience in pharmaceutical development with focus on solids formulation

  • Master's degree in Pharmacy, Pharmaceutics, Industry Pharmacy, or related field with 5 or more years experience in pharmaceutical development

  • Ph.D. in Pharmacy, Pharmaceutics, Industry Pharmacy or related field with 3 or more years experience in pharmaceutical development.

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

  • Position requires occasional travel

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.


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Senior Development Scientist

Mayne Pharma Group Limited