Temp Support for Dp Manufacture

3 weeks ago


Alnwick, United Kingdom Quotient Sciences Full time

**Head of Process Research and Development**

**Company Overview**

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 save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented 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 community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

**The Role**

We are currently looking to hire a Deputy Head of Drug Product Manufacturing on a temporary support basis. The role will be co-ordinating and managing scientists and technicians involved in the dispensing, manufacture and supply of clinical products in accordance with GMP requirements and company procedures.

**Main tasks and responsibilities**
- 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.
- Dispense APIs, excipients, drug products, IMPs and packaging materials for clinical use and maintain GMP stocks as required.
- Work with formulation development scientists to translate developed formulations/process’ to final clinical products.
- Co-ordinate the cleaning, maintenance, validation and upkeep of the GMP manufacturing facility, utilities and equipment.
- Advise clients and colleagues on GMP standards to be applied during product manufacture.
- Manage the GMP material inventory including goods receipt, storage and stock control; liaising as appropriate with the Quality Control and Microbiology Team.
- Support the conduct of internal, client and regulatory agency audits of the GMP product manufacturing capabilities.
- Deputise for the Head of Drug Product Manufacturing when appropriate to discharge the responsibilities of the ‘Head of Drug Product Manufacturing’ on the site MIA (IMP) Licence and according to internal procedures.
- Discharge the responsibilities of the ‘Head of Drug Product Manufacture’ on the site MIA (IMP) licence.
- Work with due regards to health and safety of self and others.
- Work flexibly across the site to meet business needs.

**Qualifications and experience required for competent performance**
- Extensive knowledge and experience of pharmaceutical manufacturing.
- Good awareness of the current GMP regulatory environment.
- Knowledge of the drug development process.
- Experience in guiding professional or technical staff.
- Good written and oral communication skills.
- Have a flexible approach to new work challenges.

**Company Benefits**:
In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

**Our Commitment to Diversity & Inclusion**

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.



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