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.
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
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.
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
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.
Mayne Pharma Group Limited