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Technical Manager - Sterile Processing (Fill/Finish), MSAT

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive salary
Start date
5 Aug 2019
Closing date
4 Sep 2019

View more

Discipline
R & D , Biotechnology
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

We are very proud to announce that our Manufacturing, Science and Technology are now hiring for our brand new Facility “Oxbox”.

http://www.oxb.com/news-media/press-release/oxford-biomedica-announces-further-capacity-expansion-new-facility

As our Technical Manager you will be our chosen subject matter process engineering expert for our new Fill/Finish function. Your key objective will be to manage all GMP aseptic processing support activities within the new facility, providing technical support to in-house and third party clinical and commercial sterile manufacturing activities.

 Key responsibilities:

  • Provide technical and scientific leadership within OXB on aseptic processing and fill/finish activities for clinical and commercial manufacturing including technology transfer, technical troubleshooting, and continuous improvement of sterility assurance
  • Act as Subject Matter Expert (SME) utilising your technical competence and knowledge in aseptic processing, fill-finish, inspection and packaging to provide guidance on best practices to improve aseptic processes and procedures and maintain regulatory compliance
  • Coordinate cross-functional root cause investigations as appropriate using a systematic approach to resolve complex problems and lead multidisciplinary teams in developing and implementing solutions
  • Generate and review documentation supporting technology transfer and New Product Introductions (NPI). Define appropriate success criteria for technical transfer and provide/document evaluation of the technical outcomes
  • Responsible for associated OXB documentation to ensure quality and compliance required for regulatory submissions
  • Develop and maintain relationships with key suppliers and technology providers

Key requirements:

  • Bachelor degree (Masters/PhD/EngD preferred) or equivalent experience in a relevant science (e.g. Biological Sciences, Microbiology,) with substantial relevant experience in an industrial setting
  • Significant experience working within GMP environment ideally within multiple aseptic or sterile product manufacturing facilities
  • Experience in preparation for and participation in inspections (including FDA & MHRA) as well as performing focused GMP audits of sterile facilities
  • Experience in the design and use of single-use systems in sterile manufacturing would be ideal.
  • Experience of providing innovative solutions to solve complex problems in aseptic processing, and lead multidisciplinary teams in developing and implementing solutions.
  • Proven influencing skills at all levels of seniority
  • Excellent communication skills (including verbal and written) able to interact cross-functionally at all levels
  • Proven capability of keeping abreast of, and implementing scientific and technological advancements

We look forward to receiving your application.

No agencies please.

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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