Senior GMP Production Scientist

Senior GMP Production Scientist

Orbsen Therapeutics

Birmingham, United Kingdom

Senior GMP Production Scientist – Orbsen Therapeutics UK Ltd.
Ref. No. ORB-ATF 01 -19

Applications are invited from suitably qualified candidates for the position of GMP Production Scientist at the Orbsen Advanced Therapy Facility (ORB-ATF) which is based on the University of Birmingham UK campus.

Orbsen Therapeutics is a biopharmaceutical company, focused on the development of next generation stromal cell immuno-therapies. These therapies target the immune system to resolve immune mediated inflammatory diseases. Orbsen, with strong financial backing has both the ambition and technologies to become a leader in stromal cell immunotherapies.

Orbsen has recently opened 4 clinical trials, assessing our patented stromal cell therapies ORBCEL-M and ORBCEL-C in patients with diabetic foot ulcers, autoimmune disease, diabetic kidney disease and acute respiratory distress syndrome.

Orbsen is building a leading biotechnology company with the ambition to be a leader of a revolution in medicine in which life-threatening diseases are treated by a next generation allogeneic “off the shelf” products. We are currently scaling up our in-house capabilities in development, GMP manufacturing and clinical development. This is a fantastic opportunity to join a fast-paced collaborative environment within an innovative company that aims to make a real impact in the field of stromal cell immunotherapies.

Role Summary:
We are seeking an experienced bright, enthusiastic and motivated GMP production scientist with experience in the field of cell therapy Advanced Therapeutic Medicinal Products (ATMPs) to join our growing multi-disciplinary team, and support the development of our next generation stromal cell immunotherapies. As a Senior GMP production scientist you will lead the technology transfer, validation and clinical production of ORBCEL-M and ORBCEL-C. This individual will work closely with Heads of Production, Process Development, Analytics and Quality teams to support ORBCEL manufacturing activities.

Key Responsibilities:
Leading GMP activity for the manufacture of our ORBCEL therapies, facilitate technology transfer, process validation, equipment validation and qualification, stability studies and materials management.

Support product development activity in closed system cell culture, identifying and implementing procedures in accordance with GMP and regulatory standards.
Support continued development and in-process improvements to streamline process operations and optimise manufacturing methods.

To assist in the preparation and review of GMP documentation including IMPD, BMRs, SOPs, user requirement specifications, as well as to support the management of Quality Management System including change controls, process deviations, and risk assessments to ensure the highest levels of controls and traceability.

Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements, GMP regulatory and quality standards.
Assist in coordination of production scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product.

To coordinate activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
Be accountable to the head of production for all production operations.

Desirable experience:
3 years’ experience working in a regulated environment (GLP/GCLP/GMP)
Experience in human cell isolation, cell culture in a GMP compliant environment
Experience of working in a Grade B cleanroom production environment
ATMP process development experience
Bioreactor experience
Testing experience in biological and/or microbiological assays
Experience in Flow Cytometry, QPCR and Karyology
Understanding of GMP, ATMP, and EUTCD regulations
Participation in regulatory audits e.g. MHRA
Have excellent planning and organisational and time management skills
Have excellent communication and interpersonal skills

Qualifications:
BSc or MSc in Biological Science discipline.
Successful candidates will also possess excellent communication skills and be highly organised with a desire to solve challenging scientific questions whilst working in a dynamic, fast paced team environment.

Start date: March 2019
This is a permanent position, based in Birmingham, UK, with a competitive salary and benefits package to match experience.
Further information about Orbsen Therapeutics UK is available at https://orbsentherapeutics.com/; Informal contacts concerning the post may be made to Dr. Lisa O’Flynn via e-mail to lisa.oflynn@orbsentheraepeutics.com

To apply:
Applications to include a covering letter, CV, and the contact details of three referees should be sent to: triona.quinn@orbsentherapeutics.com

Applicants must include the post ref. no: ORB-ATF 01-19 in subject line of e-mail application.

Closing date for receipt of applications is 5.00 p.m. on Friday 8th February 2019

Orbsen Therapeutics UK Ltd. is an equal opportunities employer.

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Senior GMP Production Scientist