+ Head of Manufacturing



Required Education: Bachelor's degree or Master's degree in chemical engineering, biological engineering, chemistry, biochemistry or biology




General Description

The Head of Manufacturing will be responsible for the management of all anaerobic microbiological manufacturing activities. The position requires leading the manufacturing and process team and be the process expert in contact with Clients and Contract Manufacturing Organizations (CMOs). The selected candidate will be responsible for developing, scaling up and improving microbial fermentation based processes in collaboration with external and internal parties.




Primary Responsibilities

The selected candidate will initiate, plan, guide, and coordinate the process development activities and be responsible for its timely and accurate execution. The position requires exceptional technical and scientific ability combined with an understanding for regulatory requirements and the ability to conduct processes under controlled circumstances and strict documentation and requirements of cGMP, while continuously meeting timelines. The Head of Manufacturing will be able to offer assistance in the development, optimization and scale up of anaerobic microbial fermentations. Additional expertise in down-stream processes such as freeze drying is desired. The candidate must have experience in technology transfer processes, especially to cGMP environments. Detailed knowledge of FDA regulations is desired. The Head of Manufacturing will have strong analytical and problem solving skills. Data analysis and interpretation will be focused and result in thorough documentation and pointed technical reports. The position requires the candidate to be able to ensure the process and manufacturing team lives up to the quality and documentation requirements and should be able to conduct all activities with attention to detail and with thorough documentation. The selected candidate will be well versed in internal and external best practices, lead internal and external projects, and be the process expert in interactions with clients. It is expected that the Manufacturing Lead will continuously improve operational effectiveness and participate actively in the recruitment of technical staff to maintain an effective level of technical ability for all business requirements.



Qualifications

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

• Bachelor's degree or Master's degree in chemical engineering, biological engineering, chemistry, biochemistry or biology
• Strong background/interest in chemical/biochemical processing
• Experience with microbial culture, fermentation, recombinant
protein expression, process simulation, design of experiments (DOE), process development, process optimization and scale-up, is desired.
• Ability to independently plan, initiate and coordinate manufacturing and process development and to solve complex problems
• Good interpersonal skills and positive attitude in cross-functional settings
• A systematic approach to tasks and strong quality and documentation skills
• Numerical and analytical ability
• Strong oral and written communication
• Strong performer of solid results and work of consistently high quality
• Ability to lead small teams and manage multiple projects simultaneously
• Ability to work with external and internal teams to reach goals in a timely manner
• Knowledge of FDA regulations is desired, ability to work in cGMP environment is required

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