Director, Process Research and Development
- Recruiter
- Oxford BioMedica (UK) Limited
- Location
-
Oxford
South East EnglandUnited Kingdom
- Salary
- Competitive
- Posted
- 18 May 2022
- Closes
- 10 Jun 2022
- Job Title
- Associate Director
- Category
- Scientific and Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
Job description:
Our employees are able to develop their careers in exciting new medical technologies, and so can you.
Oxford Biomedica's Process R&D team consists of experienced scientists and engineers that have extensive expertise in all aspects of upstream and downstream development. PR&D take processes from the laboratory "bench" scale and apply process expertise and engineering fundamentals for delivery to Manufacturing.
We are currently recruiting for a Director, Analytics to join the team. The purpose of this role is to lead multi–disciplinary teams to provide timely delivery of Process R&D analytical services, ensuring timelines are met whilst maintaining compliance with the appropriate quality and safety guidelines and sustaining the high quality work conducted within PR&D at OXB
Your responsibilities in this role would be:
* Accountable for the effective performance of the Process R&D Department, with tactical focus on ensuring all Process R&D analytical testing is scheduled and results are delivered on time for client–facing and in–house development programmes
* Accountable for control management, assay maintenance, data trending & analysis
* Ensure all testing performed in compliance with the appropriate Quality, Safety and Environmental guidelines
* Take primary responsibility for coordinating analytical testing for client and in–house development programmes and regulatory submissions where required
* Performance management of Scientists & Laboratory Technicians; providing development opportunities, managing poor performance, resource planning, recruiting, motivating and building a strong team
* Lead multi–disciplinary teams to ensure all analytical testing is performed to the appropriate quality standard and reported in a timely manner to facilitate process development
* Assay and control material maintenance including data trending & analysis, to ensure continuity of testing
* Ensure robust and compliant procedures in place to receive, issue, ship and dispose of analytical samples
* Ensure analytics laboratories maintained to a high standard at all times, equipment is maintained and serviced, sufficient equipment & robust procedures for scheduling of analytical testing
* Champion upcoming analytical technologies, and keep up to date with current literature and thinking.
* Responsible for developing a resource strategy for the Process R&D Analytics team and identifying and communicating resource requirements for the department
* Proactively identify project risk and issues to the relevant internal stakeholders and external collaborators at an early stage
* Accountable for own and team's performance in alignment with group objectives and deadlines
* Work in accordance with the OXB quality management system
* OXB PR&D Analytics representative at Client meetings, Client audits, Regulatory inspections and site visits by third parties
* Interacts and influences with other key functions such as QA, Supply Chain, Analytical Services Group (ASG), Manufacturing Sciences & Technology (MSAT), Analytical Development (ADG) and QC at the manufacturing facility
To be successful in this role, you will have the following skills and experience:
* PhD or equivalent degree in a relevant Science (e.g. Biological sciences, Biochemical Engineering, Virology, Molecular/Cellular biology) with extensive experience
* Project Management qualification preferred
* Excellent knowledge of the regulatory requirements for analytical work (e.g. ICH, product specifications, stability testing guidelines etc.)
* Excellent technical understanding of biopharmaceutical process development and manufacturing
* Has a broad and deep understanding of the full life cycle of the development of a product.
* Broad knowledge of specific company processes for development and delivery of scientific process
* Excellent knowledge and experience of cell culture, qPCR and ELISA.
* Sophisticated relationship management skills to influence at high levels within Process R&D and OXB as a whole
* Strong negotiating and analytical skills.
* Strong Leadership experience
* Strong oral communication and interpersonal skills
* High level of experience using Microsoft Excel and/or Microsoft Project or other relevant software
Do you want to feel inspired every day? We're future–focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.
Collaborate. Contribute. Change lives.
No agencies please
We offer:
We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you.
We are pioneers; no one else does what we do.
Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient's cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible.
We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners.
We drive credible science to realise incredible results.
Whether you're motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.
Our employees are able to develop their careers in exciting new medical technologies, and so can you.
Oxford Biomedica's Process R&D team consists of experienced scientists and engineers that have extensive expertise in all aspects of upstream and downstream development. PR&D take processes from the laboratory "bench" scale and apply process expertise and engineering fundamentals for delivery to Manufacturing.
We are currently recruiting for a Director, Analytics to join the team. The purpose of this role is to lead multi–disciplinary teams to provide timely delivery of Process R&D analytical services, ensuring timelines are met whilst maintaining compliance with the appropriate quality and safety guidelines and sustaining the high quality work conducted within PR&D at OXB
Your responsibilities in this role would be:
* Accountable for the effective performance of the Process R&D Department, with tactical focus on ensuring all Process R&D analytical testing is scheduled and results are delivered on time for client–facing and in–house development programmes
* Accountable for control management, assay maintenance, data trending & analysis
* Ensure all testing performed in compliance with the appropriate Quality, Safety and Environmental guidelines
* Take primary responsibility for coordinating analytical testing for client and in–house development programmes and regulatory submissions where required
* Performance management of Scientists & Laboratory Technicians; providing development opportunities, managing poor performance, resource planning, recruiting, motivating and building a strong team
* Lead multi–disciplinary teams to ensure all analytical testing is performed to the appropriate quality standard and reported in a timely manner to facilitate process development
* Assay and control material maintenance including data trending & analysis, to ensure continuity of testing
* Ensure robust and compliant procedures in place to receive, issue, ship and dispose of analytical samples
* Ensure analytics laboratories maintained to a high standard at all times, equipment is maintained and serviced, sufficient equipment & robust procedures for scheduling of analytical testing
* Champion upcoming analytical technologies, and keep up to date with current literature and thinking.
* Responsible for developing a resource strategy for the Process R&D Analytics team and identifying and communicating resource requirements for the department
* Proactively identify project risk and issues to the relevant internal stakeholders and external collaborators at an early stage
* Accountable for own and team's performance in alignment with group objectives and deadlines
* Work in accordance with the OXB quality management system
* OXB PR&D Analytics representative at Client meetings, Client audits, Regulatory inspections and site visits by third parties
* Interacts and influences with other key functions such as QA, Supply Chain, Analytical Services Group (ASG), Manufacturing Sciences & Technology (MSAT), Analytical Development (ADG) and QC at the manufacturing facility
To be successful in this role, you will have the following skills and experience:
* PhD or equivalent degree in a relevant Science (e.g. Biological sciences, Biochemical Engineering, Virology, Molecular/Cellular biology) with extensive experience
* Project Management qualification preferred
* Excellent knowledge of the regulatory requirements for analytical work (e.g. ICH, product specifications, stability testing guidelines etc.)
* Excellent technical understanding of biopharmaceutical process development and manufacturing
* Has a broad and deep understanding of the full life cycle of the development of a product.
* Broad knowledge of specific company processes for development and delivery of scientific process
* Excellent knowledge and experience of cell culture, qPCR and ELISA.
* Sophisticated relationship management skills to influence at high levels within Process R&D and OXB as a whole
* Strong negotiating and analytical skills.
* Strong Leadership experience
* Strong oral communication and interpersonal skills
* High level of experience using Microsoft Excel and/or Microsoft Project or other relevant software
Do you want to feel inspired every day? We're future–focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.
Collaborate. Contribute. Change lives.
No agencies please
We offer:
We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you.
We are pioneers; no one else does what we do.
Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient's cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible.
We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners.
We drive credible science to realise incredible results.
Whether you're motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.