Title:  Scientist

Job Title:          Scientist

Summary:

• This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are

conducted, and process improvements are evaluated/ implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

Essential Duties and Responsibilities:  

• Applies knowledge or quickly learns cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Performs a variety of projects/studies in areas that may include Product/Process, Sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations.
• Writes protocols, reports (GTRs), Site and Master Batch Record Change Controls and Executes protocols that involves coordination with many functional areas including Production, Planning, Testing Laboratories, etc.
• Serves as project lead with projects of intermediate scope and cross-functional teams.
• Mentors and provides leadership to junior team members.

Qualifications            

• Ability to communicate effectively at all levels in verbal and written form.
• Direct or indirect industry knowledge and the ability to learn new technical information and concepts.
• Ability to work independently or in teams.
• Ability to walk some distance 1-3 miles, stand for 3-6 hours and periodically lift 10 - 40 lbs. during the course of a work day as required.
• Ability to work any shift (1st, 2nd, or 3rd) and any day of the week (7 days) as duties require.

Education and/or Experience        

• BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) having a minimum of 3+ years related experience or 2+ years related experience w/ an advanced degree or demonstrated performance within a technical department within the organization.