Summary:
Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Sciences is made of six main functional teams namely:
- Upstream Sciences
- Downstream Sciences
- Analytical Technologies Team
- Data Analytics and Modelling
- Manufacturing Support & Process Validation
- Project Management and Operations
This position is technical leadership role within Manufacturing Support, whose major focus is investigating process deviations associated with manufacturing biological products.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Lead investigations of process related deviations, ensuring they are closed out in a timely, comprehensive and conclusive manner.
- Author, review and approve documentation associated with root cause investigations; along with product impact assessments.
- Provide technical leadership; specifically coaching and mentoring to more junior group members.
- Lead or participate in process and quality risk assessments.
- Drive continuous improvement programs.
- Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
- Support the site through regulatory audits by providing technical expertise.
Knowledge and Skills:
- Experience in biotech industry with good knowledge of manufacturing processes (specifically upstream unit operations) and biological products.
- Knowledge of use and application of variety of problem-solving tools (e.g. Fishbone, Kepner-Tregoe etc.).
- The ability to work effectively in a fast-paced environment with changing priorities and a high level of urgency.
- Strong verbal and written communication skills
Education and Experience:
- Bachelor, Master, or Doctorate degree in Life Sciences, Biological/Chemical Sciences, or Process/Chemical Engineering.
- A minimum of a BA/BS and a with 8 years relevant experience, MS with 7 years, or PhD with 2 years
