Industry: Pharmaceutical Production / Operations
Training: Yes (Full).
The Operational Head of the Fermentation Operations Team will take responsibility for the operational activities within the Development Group. This includes, but is not solely limited to, recruitment, staff performance, appraisals, supervision and training. They will constantly plan and prioritise the upstream activities to fit timelines and budgets. In addition they will act as a lead specialist for fermentation and related microbiological activities. The post-holder will take a lead role in the design of study programs, liaising with customers through teleconferences, reports, presentations and technology transfers. They will also provide specialist expert knowledge in the area of upstream development and process scale up leading to GMP manufacture.
He/she will provide a scientific and technical specialism in the area of Fermentation/Upstream Processing to projects involved in the development of processes for the manufacture of biopharmaceutical products. The post holder will be knowledgeable in the area of Quality by Design/Design of Experiments, fermentation process and media development, scale-up and validation. They will be required to work in multi-disciplinary teams, leading as required to deliver key objectives. They will lead in the generation of experimental designs, presentation of work to internal and external customers and the preparation of scientific publications, technical reports and project proposals. They will play a key role in the technology transfer activities relating to the development and/or manufacture of biopharmaceutical products internally or between the client and its collaborators/customers.
MAIN DUTIES AND RESPONSIBILITIES
- To manage the activities of the Fermentation Operations Team, dedicated to the development of GMP and non-GMP production processes, ensuring that appropriate methods, assays, techniques/systems are implemented and utilized to meet project targets.
- To work closely with the Director and Deputy Head of Development and other relevant functions in the negotiation and initiation of new studies involving the Fermentation Operations Team.
- To take on Project Management tasks, as appropriate, in consultation with the Director and Deputy Head of Development and other relevant functions.
- As a lead specialist for the Fermentation Operations Team, take a lead responsibility for liaising with customers including teleconferences, project reports, presentations and on- site/off-site visits. Deal with enquiries as necessary.
- To provide specialist expert knowledge in the area of pathogenic and non-pathogenic microbial cultivation, the development of fermentation processes/techniques for maximizing expression of proteins of interest and process scale-up design leading to GMP manufacture for PBL and its customers.
- Take responsibility for the initiation and development of research and development activities for new projects in area of expertise.
- Lead on the design of study programs and constant monitoring, evaluation and re- prioritization of the group’s activities as necessary to fit project time-lines.
- Take responsibility in ensuring that any product developed within the group destined for the production market (e.g vaccine candidates, therapeutic products) would be suitable for use in clinical trials.
- Take responsibility for the technology transfer of programs into and out of the Fermentation Operations Team involving both internal client groups (Pharmaceutical Production and Development) and external customers (Contract Manufacturers), including the design and development of Batch Manufacturing Records
- PBLF-014-01 30 Apr 15 Page 2 of 5
- (BMR) and associated cGMP documentation.
- Evaluate and adapt new technologies where appropriate and ensure that projects operate
- to a high scientific standard using current methods.
- Take responsibility for the provision of reagents and consumables required for projects and documented storage of materials generated.
- To direct staff activities, recruit staff, encourage personal development and carry out staff performance appraisals.
- Take responsibility for the supervision and training of staff.
- To ensure good communications within the group on matters such as safety, quality, training, project aims and time lines.
- Take responsibility for all data generated by the Fermentation Operations Team ensuring that it is valid and complies with PBL`s quality standards.
- Undertake all assigned work in accordance with the PBL Risk Management Systems and Code of Safety Practice.
- To help in the management, control and operation of the Development Group`s Standard Laboratory Protocol (SLP) system, with responsibility for those relating to the Fermentation Operations Team.
- To perform any other duties required by the line manager commensurate with grade.
- To comply with all PBL policies and procedures.
- BSc in biological sciences/ biochemistry/ biotechnology/bio-medical sciences
- PhD/MSc in a biochemical/biotechnological discipline
KNOWLEDGE AND EXPERIENCE
- Several years relevant laboratory experience with practical knowledge of Quality by Design, Design of Experiments, fermentation process and media development, scale-up, and analytical methods.
- Experience of working within a commercial scientific environment
- Working with microorganisms in containment
- Demonstration of external collaborations and pipeline generation
- Experience in managing teams
- Technology transfer & Process validation experience
- Participation in multidisciplinary project teams
- Understanding of GMP and other regulatory requirements
SKILLS & CAPABILITIES
- Technical writing of protocols, scientific publications, project reports
- Working to a quality/safety systems
- Good oral and written communication skills
- Ability to work in project teams and to plan own and others work
- Delivery of project milestones to agreed timescales
- Media Development