Primary area of responsibility is to provide development of pre-formulation particle size control steps for Active Pharmaceutical Ingredients (APIs) using technologies such as jet milling, hammer milling, cone milling, sifting, and wet milling. Plans and executes milling of key clinical and scale-up batches in support of new products. Ensures projects are managed and completed on target with quantity, quality, time, and within budget. A second area of responsibility will be process engineering for chemical development of new API processes using current software tools for modelling. Responsible for contributions to continuous improvement in customer satisfaction, operational safety and efficiency of the function.
- Works with Department and Assistant Director Process Engineering to build and enhance particle size capabilities for API manufacturing at JMPS as well as within the wider division.
- Hands-on execution of milling and particle size development experiments, carrying out milling development as well as GMP milling operations so that definitive conclusions are made and deliverables are met. Work will involve collaborative work with chemists, plant and quality personnel.
- Develops and maintains awareness of developments in particle size technology through literature review, conferences, vendor discussions and related activities.
- Performs milling and particle engineering process development in accordance with Johnson Matthey policies and practices with respect to GMP, environmental, health, and safety (EH&S) and other related regulatory requirements.
- Develops expertise in computer modeling using VisiMix for reactor agitation and using Dynochem for data fitting, heat transfer characterization of plant reactors, mass transfer/hydrogenation modelling as well as modelling for solubility and solvent selection/crystallization development, and reaction kinetic data fitting.
- Other duties as assigned.
- Manages projects, equipment and deliverables in full compliance with cGMP requirements and Johnson Matthey quality policies and practices.
- Implements and applies cGMP concepts in association with department specific responsibilities.
- Demonstrates technical expertise and self-assuredness in applying cGMP standards.
ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBITILIES
- Manages projects, equipment and deliverables in full compliance with all appropriate EH&S policies and procedures.
- Actively participates in root cause investigations on near misses and all incidents. Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department.
- Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability principles into daily activities.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
- Must be able to lift and/or move up to 25 pounds.
- Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
- Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures.
- Moderate travel may be necessary for technical meetings, customer visits, and supplier contacts.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE
- Minimum BS in Chemical Engineering or similar discipline with a minimum of 2 years related experience in a pharmaceutical or fine chemical industry. MS degree is strong plus.
- Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents
- Ability to write clear and concise technical reports, business correspondence and procedure manuals
- Demonstrate ability to exercise good judgment and make decisions quickly
- Good organizational and planning skills with ability to multi-task effectively.
- Excellent verbal communication skills and confidence to act as client interface.
- Extensive knowledge of Microsoft Office
- Ability to define problems, collect data, recognize patterns, and draw valid conclusions and deal with both abstract and concrete variables
- Ability to work independently and in an interdepartmental team environment
- Appreciation and knowledge of chemical engineering principles and how to apply them to process development and scale up.
- Knowledge of analytical techniques for particle size, form and crystallinity.
- Experience with Dynochem, VisiMix, Aspen or other software packages
- Experience with Equipment Specification, Equipment Qualification & Process Validation
- Experience with engineering controls and methodologies for safe handling of potent compounds
- Knowledge of Microsoft Project and project planning experience