Process Development Scientist

A global diagnostics company requires an experienced Process Development Scientist to join its team. You will be responsible for organizing and conducting process transfer activities including planning, documentation, and training, in accordance with standardoperating procedures. To be considered you must have previous experience supporting tech transfer processes within the biotech, biopharma, diagnostic or pharmaceutical industries.

**The Role**:
Responsible for organizing and conducting process transfer activities including planning, documentation, and training, in accordance with standard operating procedures. Applies scientific principles and expertise in the design and development of robust,cost-effective biotechnology and biopharmaceutical processes into production and enables the successful development, scale-up and transfer of new fermentation and downstream processes from R&D through to production.

**Responsibilities**:
Will perform some or all of the following:

- Collaborates with Research and Development (R&D) staff to design experiments for process characterization, performance qualification of equipment, and the development of finalised Process Outlines and bill of materials for new processes
- Support the completion of new client project proposals by working in conjunction with R&D staff to develop draft Process Outline documents from customer Request for Proposals (RFP's)
- Author Process Transfer documentation including production, batch records, process safety, Control of Substances Hazardous to Health (COSHH) and Transmissible Spongiform Encephalopathy (TSE) risk assessments
- Author departmental and Production User Requirement Specifications (URS') and Standard Operating Procedures (SOP's) for new equipment to facilitate training and standardise equipment cleaning, set-up and operation
- Author process qualification (PQ) documentation, including PQ protocols and PQ reports
- Provide technical and operational support to ensure development, engineering and qualification batches are manufactured in accordance with agreed regulatory, quality and customer requirements
- Identify improvements to manufacturing processes and initiates Process Change documentation, including pre
- requisite technical reports and supporting documentation
- Complete manufacturing operations for existing and new products according to written procedures and general instructions in line with Current Good Development Practices (cGDP's) and Current Good Manufacturing Practices (cGMP's)
- Train Production staff in new processes and procedures aligned to Process Support and Process Transfer activities
- Support general laboratory housekeeping and maintenance, including analytical instrument maintenance
- Identify and implement improvements to departmental SOP's and ways of working
- Support cross functional business improvement projects
- Provide information to support internal and external quality, regulatory and customer audits
- Represent Process Support and Process Transfer functions during internal quality audits
- Support Environmental Management System (EMS) activities and compliance per ISO14001
- Understand and is aware of the quality consequences which may occur from the improper performance of their specific job
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects

positively on the company and is consistent with the company's policies and practices
- Carry out duties in compliance with established business policies
- Additional duties, as assigned

**Education & Experience Required**:

- A university degree in a relevant scientific discipline
- 3-5 years' experience working in a process support, or technology transfer function within the biopharmaceutical, pharmaceutical or biotechnology industry
- A combination of education and experience will be considered

Skills / Pre-requisites:

- Strong interpersonal and relationship building skills
- Strong collaboration and facilitation skills
- Excellent planning and organisational skills
- Excellent oral and written communications skills
- Analytical thinking and problem solving
- Training:_
- Knowledge of Quality System (QS) Regulations for cGMP, ISO 13485 Medical Device and ISO 9001 requirements