Director of Operations
Siter-Neubauer & Associates is currently conducting a search for Director of Operations :
Have you got what it takes to succeed The following information should be read carefully by all candidates.
My Client is a major player in the bio-therapeutic market space. Their products are selling well. The pipeline is full. They are in a growth mode.
Job Description
They are seeking to fill a very important position - the Director of Operations. The successful candidate will be responsible for overseeing the construction of a clean room facility and the development of the biologic / cellular therapy product with a unique delivery system.
This will entail the scale-up and tech transfer of biologic products into manufacturing.
Qualifications
- Provide leadership to cross-functional teams to perform technology transfers, process validation, scale-up and optimization activities.
- Experience in working as part of a cross-departmental team and successfully integrating with R&D, Clinical, Regulatory, Manufacturing and Quality groups.
- Requires strong project management experience and process improvement experience, with at least 10 years relevant experience leading technical services / operations, process development, and / or engineering support activities.
- A working knowledge of regulatory pathways employed for product development and changes to approved products.
- Knowledge of regulations and guidance such as cGMP, QSRs, SUPAC, and ICH is required to allow oversight of the variety of projects tasked to this position.
- Lean / Six Sigma Green Belt certification and experience considered an advantage.
- Must have technical expertise in various cell culture methods to oversee the scale-up, tech transfer and large scale production of biologic products.
- In-depth knowledge of compliance with cGMP requirements, ISO environments, and FDA regulations for a sterile, Class A manufacturing environment.
- Technical expertise in cell culture, virology, fermentation, and protein purification with a 4 year degree in Biology, Immunology, Biochemistry, or similar.
- Implementation of Six Sigma, Kaizen, PDSA, and other CIPs.
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