Process Development Specialist
We are seeking a highly skilled and experienced professional to support the development of new processes within our organization.
About This Role
The ideal candidate will be responsible for supporting the start-up of new processes through documentation preparation, review, and approval. Additionally, they will monitor processes during start-up/validation and ongoing manufacture, and establish strong deviation investigation support and technical writing skills.
* Work with process teams to provide hands-on support of documentation preparation, review, and approval.
* Understand electronic batch records, process flow documents (PFD), and validation of processes and products being supported.
* Ensure PFD accurately describes process, control strategy, process parameters, CQAs, and references to supporting material.
The successful candidate will have a BSc in Chemistry, Biochemistry, or a related science field with 3-5 years' experience in pharmaceutical manufacturing, or an MSc in Chemistry, Biochemistry, or a science-related field with 3+ years' experience in pharmaceutical drug substance manufacturing support.
Key qualifications include technical depth in manufacturing science, understanding of documentation requirements, excellent verbal and written communication skills, strong analytical and problem-solving skills, collaborative skills with operations, process engineering, quality control, and other process team members, as well as ability to coach others.
This is a fantastic opportunity for a motivated individual to develop their expertise and contribute to the growth and success of our organization.