Manufacturing Lead/ Supervisor

3 weeks ago

Alnwick Northumberland, United Kingdom Quotient Sciences Full time

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,300talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development communitythat’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. We are currently looking to hire a Deputy Head of Drug Product Manufacturing on a permanent basis. The role will be co-ordinating and managing scientists and technicians involved in the dispensing, manufacture and supply of oral and intravenous clinical products in accordance with GMP requirements and company procedures.
The role will be focussed on sterile manufacturing processes and technology , aseptic processing and regulatory requirements. The role will require a ‘hands on’ approach to ensure the drug products are manufactured on time to the correct quality and specification.
Apply scientific expertise and experience to the manufacture and supply of oral and intravenous products for human use.
Prepare, review and where appropriate approve, documentation associated with the manufacture and supply of Investigational Medicinal Products.
Guide other team members of the GMP manufacturing team to ensure that products of the correct quality are manufactured and documented in compliance with relevant regulatory requirements, internal policies/procedures and client needs.
Co-ordinate the cleaning, maintenance, validation, GMP material inventory stock control and upkeep of the GMP Drug Product manufacturing facility, utilities and equipment.
Effectively lead the site media fill program, including operation training and qualification, site gowning practices, environmental monitoring program, sterilisation practices and aseptic technique.
Responsible for contributing to the cleanroom operation and contamination (cGMP) in the performance of the day to day activities.
Develop and maintain training programmes.
Microbiology, Quality Control, Quality Assurance, Soft Services and Facility Management.
Manage and support manufacturing investigations, including root cause analysis, CAPA generation and impact assessment.
Advise clients and colleagues on GMP standards to be applied during drug product manufacture.
Support the conduct of internal, client and regulatory agency audits of the GMP Drug Product manufacturing capabilities.
Deputise for the Head of Production when appropriate to discharge the responsibilities of the ‘Head of Production’ on the site MIA (IMP) Licence and according to internal procedures.
BSc (hons) or equivalent in a relevant scientific subject.
Extensive knowledge and experience of pharmaceutical manufacturing including sterile manufacturing processes and technology and aseptic processing.
Good awareness of the current GMP regulatory environment.
Knowledge of SOPs, cGMPs and how to work and manage within a regulatory environment.
Have a flexible approach to new work challenges.
#It has been and will continue to be a fundamental policy of Quotient Sciences not to discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This policy applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
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