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Director, Manufacturing Compliance and Improvements

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
12 Oct 2021
Closing date
11 Nov 2021

View more

Discipline
Quality, GMP, R & D , Biotechnology
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Job description:
 

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 teamwork, and so can you.

 

Oxford Biomedica’s Manufacturing Team is responsible for the production and aseptic fill and finish of vectors, for our clients and partners, to GMP standard.

We are looking for a talented Director to develop, lead and improve the Manufacturing function with the management of the supporting functions. This will be performed through leading and supporting the Training, Process Compliance, Continuous Improvement & Technical Writing Teams.

Your responsibilities in this role would be:

  •  Accountable for the performance of the Process Compliance, Training, Continuous Improvement, Technical Writing.
  • Being accountable for the for the manufacturing quality metrics ensuring they are within a state of control
  • Ensuring the manufacturing training standards in place are effective and are continuously improved
  • Deliver continuous improvement (CI) projects in a timely manner and ensure they add value
  • Ensuring technical documentation is available when required and changes are timely created/adapted 
  • Recognise process compliance deficiencies and drives continuous improvements, evaluating multiple source information to identify best practice
  • Accountable for leading, coaching and motivating direct reports
  • Oversee compliance with internal and external GMP requirements to ensure successful regulatory audits, product license applications or renewal of regulatory product licenses
  • Ensure the training, within Manufacturing, is robust and efficient through leading the training team.
  • Oversee the Continuous Improvement initiatives within Manufacturing

 


Profile description:

 

 

 

To be successful in this role, you will have the following skills and experience:

 

 

  • Educated to degree level in a life science, and/or experience of working to GMP standard within an life sciences manufacturing environment
  • Proven experience managing and leading improvements within a GMP production, training, and documentation environment
  • Good understanding of local and international GMP standards and a working knowledge of pharmaceutical quality management systems, including a broad, cross-functional knowledge of the workings of a pharmaceuticals business
  • Some experience of leading and/or managing training teams
  • Clear understanding of Lean and/or Six Sigma principles
  • Proven people Management experience leading technical & diverse teams
  • Able to effectively communicate and influence both internal stakeholders and external stakeholders. 

 Collaborate. Contribute. Change lives

 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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