Job Overview

Position is directed toward optimization of existing chemical routes and development of novel alternate chemistries/processes toward key synthetic intermediates and APIs. Provides CHP site engineering support, including the design, construction, and maintenance of equipment that replicates laboratory chemical process on pilot and commercial scales. Experimental skills related to chemical process development and kilo - scale synthesis of organic compounds of medicinal importance, including chemical synthesis and product isolation/purification. Utilizes analytical tools to assess product quality and process performance. Serve as an expert chemical engineering and pharmaceutical science resource to the chemical development group, the Cambrex High Point site, and to the larger Cambrex organization. Communication with clients in regular team meetings; prepares R&D and campaign reports at the conclusion of projects.

Responsibilities
• Design and carry out multistep organic processes.
• Application of key principles of chemical engineering to work within a matrix-based chemical

development team to construct systems and design chemical processes that will efficiently

support on-scale safe production of promising pharmaceutical candidates.
• Knowledge and experience in technologies such as continuous processing and flow chemistry

is preferred.
• Knowledge of and experience with in-situ reaction monitoring technology is preferred.
• Knowledge of final form screening/polymorph screening/crystallization studies is preferred.
• Knowledge of process controls and associated programming is preferred.
• Possess a working knowledge of analytical and spectroscopic techniques, including the ability

to interpret the corresponding data.
• Demonstrate a proficiency in laboratory and pilot-scale synthesis and purification techniques,

including the implementation of process modifications.
• Demonstrate an ability to maintain lab equipment including pumps and instrumentation.
• Ability to work with minimal supervision and complete projects independently.
• Ability to organize work efficiently and manage time effectively.
• Ability to write comprehensive reports and contribute to drafting of batch records and protocols.
• Collaboration with process engineers, process development chemists and analytical chemists to coordinate project activities as well as to develop safer and more robust processes for laboratory and plant production.
• Maintain current knowledge of state-of-the-art techniques for improving engineering principles related to organic chemistry, analytical chemistry, process development techniques and cGMP regulations. Knowledge of root cause/batch failure analysis.
• Conduct laboratory operations in a safe manner. Maintain familiarity with the company's chemical hygiene plan. Exhibit safety awareness and safe work practices.
• Follow responsible actions regarding chemical disposal. Maintain compliance with all regulation at the federal, state and local levels.
• Address routine administrative requirements in a timely fashion.
• Demonstrate effective communication skills.
• Actively promote the results of ongoing projects within the group and to external clients.
• Work closely with manufacturing and GMP operations to coordinate project related equipment and activities.
• Maintain a clean and safe lab work area.

Qualifications/Skills

Chemical Engineering Knowledge: Strong understanding of undergraduate chemical engineering curriculum with examples of practical industrial or research experience relevant to the industry, some process development experience.

Equipment: Strong understanding and awareness of key engineering R&D equipment (e.g. pumps, heat exchangers, reactors) and instrumentation including controls programming, ability to perform routine maintenance, ability to effectively train others on equipment, demonstrated ability to troubleshoot

Cross Discipline Knowledge: Improved understanding of the principles of cross-functional departments, including analytical chemistry, synthetic organic chemistry and process chemistry

Instrumentation: Demonstrated ability to use, train, investigate root cause issues with HPLC, GC, good understanding of MS, uses automated reactors, may have some experience with In-situ reaction monitoring

GMP/Regulatory Knowledge: Demonstrated understanding of GMP as it relates to current work; With less manager input, can help to advise clients on key regulatory strategies

Communication: Good written and oral communication skills, ability to handle client requests with manager review.

Problem Solving: Able to solve problems in the workplace and helps to lead investigations with manager support.

Time Management: Good understanding of time management and can self-organize with or without supervision.

Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up

Technical Documentation and Review: Ability to write and review reports and technical documents with minimal RFT errors, keep current lab notebook while practicing GDP.

External Influence: Actively participates in regular internal project team meetings, including submission of key technical reports; organizes group level initiatives within the larger scientific team.

Industry Credibility and Rapport: Known as a solid scientific contributor within the department/group

Operational Excellence: Able to support key OE initiatives.

Change Orientation: Locally supports changes associated with larger Cambrex initiatives.

Education, Experience & Licensing Requirements

A minimum of M.S. in Chemical Engineering or related field with no experience or B.S. in Chemical Engineering or related field with 3 years' experience in lab environment, pharmaceutical experience preferred.

Demonstrated experience in particle engineering, micronization technologies, and particle size distribution (PSD) control, including the application of Design of Experiments (DOE) to optimize manufacturing processes and product performance. Experience with jet milling, crystallization, particle characterization, and scale-up of pharmaceutical API processes is highly preferred.

• Frequently stand, walk, and move throughout laboratory, pilot plant, manufacturing, and office environments.
• Sit for extended periods while performing data analysis, documentation, report writing, and computer-based work.
• Regularly use hands and fingers to operate laboratory instruments, computer equipment, controls, tools, and testing devices.
• Frequently reach, stoop, bend, kneel, crouch, climb stairs, and maneuver around laboratory and manufacturing processing equipment.
• Occasionally climb ladders or access elevated platforms in manufacturing plant areas while following established safety procedures.
• Lift, carry, push, and pull materials, equipment, samples, and supplies weighing up to 25 pounds independently and up to 50 pounds with assistance.
• Wear required personal protective equipment (PPE), including safety glasses, gloves, hearing protection, lab coats, respirators, steel-toed footwear, and other protective gear as required.
• Ability to distinguish colors, read gauges and instrument displays, observe experiments, and identify potential process or equipment issues.

Work Environment

• Work is performed in laboratory, manufacturing, and office settings.
• Position may require occasional off-shift work, extended hours, or weekend support to accommodate project timelines, equipment trials, process demonstrations, or manufacturing support activities.