Senior Scientist 2 – Engineering Research and Development (ERD)

Cambrex•High Point, NC

42d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.
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.

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.
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.