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Form of workJob Description
You enjoy working with people. You are collaborative, upbeat, and optimistic! You are passionate about operational excellence and providing outstanding internal and external customer service. You are a problem solver with a can-do, roll-up-your-sleeves spirit! You are exceptionally organized, thorough and self-directed. You are a proactive and clear communicator. You are interested in gaining experience in formulations, equipment, systems and processes. You are familiar with development of oral dosage forms and willing and eager to learn about systems and client relations. You draw on experience and/or bring innovative contributions to projects.
Job Summary:
Supports execution for the development of new formulations and manufacturing processes of solids, liquids, and semi-solid dosage forms. Increase and develop knowledge regarding drug toxicology, pre-clinical – phase III, scale-up, and registration. Connect with technical leads, supervisors and project team peers (analytical and project management) onthe progress and timely completion of activities and critical milestones.
Essential Functions:
Participates/supports the design, evaluation and execution of formulations for pre-clinical studies, clinical trials, registration, and scale-up as defined by client requirements.
Assures manufacturing and documentation is in accordance with cGMPs.
Participates in problem solving and stage gates for formulations, equipment and processes.
Supports or writes manufacturing batch records, reports, memos, and protocols or to support client regulatory submission to regulatory agencies.
Evaluates results and draft reports for all projects.
Participate in training, qualification of equipment, and writing Standard Operating Procedures (SOPs).
Attends project team meetings to provide information and project status updates.
Evaluates and interprets process data and provides detailed scientific review to substantiate the conclusions/recommendations in reports and for all client communication.
Maintains adequate knowledge of pharmaceutical processes, equipment, instrumentation, and procedures vital to perform the tasks. Continue to increase knowledge base of solid oral dosage form development and all its process aspects.
Recommends and assists in implementing improvements designed to enhance the efficiency, reliability, and productivity of operations all conforming to applicable regulatory standards.
Supports active manufacturing processes including in process testing, activity coordination regarding readiness for manufacturing.
Prepared to work flexible hours to accommodate the 24/7 nature of the manufacturing schedule.
Education:
Minimum Bachelor of Science (BS) in science/engineering related field. Experience in pharmaceuticals development for solid oral dosage forms (preferred).
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies:
Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory compliance.
Basic knowledge of pharmaceutical manufacturing practices
Communicates and co-operates with team to meet project and team objectives
Proficiency using Microsoft (MS) Office applications (statistical knowledge preferred)
Proficiency in written and oral communication skills
Demonstrated commitment to our 4i Values
Proficiency with the English language
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
