+ Manufacturing Associate




General Description

The Manufacturing Associate will assist the Manufacturing Lead in the development and optimization of manufacturing processes upstream and downstream. The Manufacturing Associate shows ability to independently setup and conduct fermentations, intermediate blends, and freeze drying upon given instructions and protocols. Work is thoroughly documented and clearly reported, data is analyzed and summarized. The Manufacturing Associate also assists in managing process technicians. The Manufacturing Associate will spend some time in a cleanroom environment.




Primary Responsibilities

The Manufacturing Associate is responsible for the correct and thorough execution of manufacturing plans designed by the Manufacturing lead. The Manufacturing Associate will coordinate the preparative activities and delegate as needed to Process Technicians to ensure timely completion. The responsibilities span the complete manufacturing cycle; the Manufacturing Associate will ensure that data collected during all manufacturing steps is of high quality and that data results are compiled and analyzed using industry best practices. Data is reported to Manufacturing Lead along with suggestions for improvements. In addition, this position requires the Manufacturing Associate to take initiative to research industry best practices and methods in manufacturing in order to contribute positively to the development plan and timelines. The Manufacturing Associate should have a solid technical processing background or strive to improve on the skills continuously. This position also includes being proficient to perform and document equipment maintenance and trouble-shooting, contacting vendors and suppliers, and sourcing materials and supplies. This position requires a high attention to detail and thorough documentation in batch records or notebooks. The Manufacturing Associate should also demonstrate ability to understand the importance of quality systems and the associated procedures/regulations and how they are implemented in a cGMP environment. The Manufacturing Associate will be well versed in internal methodologies and procedures and demonstrate an understanding for the scientific and technical background. The position also requires the Manufacturing Associate to be proficient in biopharmaceutical quality systems and understand the use and implementation of the same in research work.


Requirements

The requirements for being considered for the position are listed below; however, personal fit and character will be given particular consideration and weight.

  • A technical mind and ability to solve basic research problems
  • Strong internal motivation and ability to take initiative outside of assigned tasks
  • Good interpersonal skills and positive attitude
  • Strong time management skills and systematic approach to tasks
  • Effective use of own and other’s time
  • Ability to follow a written protocol and oral instructions
  • Strong oral and written communication
  • Strong performer of solid results and work of consistently high quality
  • Ability to train and instruct Process Technicians
  • Familiar with cleanroom operations

To apply for this position send your resume and letter to jobs@captozyme.com

+ Process Technician




General Description

The Process Technician will support the manufacturing and process development activities, which includes; media and buffer preparation, setup of bioreactors, environmental sampling, data collection, and simple assaying. The Process Technician will demonstrate strong time management skills, a result oriented attitude, and good documentation skills.



Primary Responsibilities

The Process Technician will perform work with minimal supervision after receiving proper training and instruction for the tasks assigned. Responsibilities include but are not limited to: buffer and media preparation, buffer and media sourcing and ordering, thorough, focused and systematic execution of fermentations and basic microbial and biochemical assays, equipment maintenance and calibration according to procedure or detailed instructions. The Process Technician will also actively participate in laboratory organization such as supply inventory, cleaning and sterilizing glassware and calibration of equipment etc. The Process Technician is responsible for thorough and accurate documentation in batch records and equipment logbooks. Some technical writing is anticipated in this position. The Process Technician will show an interest and an aptitude for internal methodologies and quality system procedure.


Requirements

The requirements for being considered for the position are listed below; however, personal fit and character will be given particular consideration and weight.

  • Strong internal motivation and ability to take initiative in assigned tasks
  • Good interpersonal skills and positive attitude
  • Strong time management skills and systematic approach to tasks
  • Effective use of own and other’s time
  • Strong technical abilities and understanding for the importance of quality systems
  • Ability to follow instructions
  • Strong oral and written communication
  • Ability to perform tasks as assigned
  • Familiar with cleanroom operations

To apply for this position send your resume and letter to jobs@captozyme.com