Senior Director, Formulation Development
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.
Due to business growth, we have a brand new career opportunity for a Senior Director, Formulation Development based at our site in Reading.
Quotient Sciences site in Reading is a growing contract development and manufacturing site (CDMO) consisting of over 80 employees, providing early phase development services through to proof of concept. Of particular focus is the development and GMP manufacture of oral dosage (solids and liquids) and inhaled drug delivery systems.
The Senior Director, Product Development will have line management responsibility for the Development function to define and manage formulation development and technology transfer of investigational medicinal products into manufacturing, to help meet the objectives of the company.
Main tasks and responsibilities:
- To devise and manage the formulation development programme for studies to ensure delivery on time, budget, and quality, including discussions with clients to agree the required extent of development.
- To provide overall leadership of product delivery for studies, with proactive approach to planning and solving issues.
- ·Responsible for ensuring regular written and verbal updates of the progress of development work are provided, and any issues that may arise, to colleagues and clients.
- To work closely with the project management department from ‘project live’ to ensure rapid and accurate initiation of study documentation
- To work closely with Business Development in securing new business and projects
- ·To review and, where appropriate, approve key study documentation to ensure accuracy and consistency.
- To write and approve pharmaceutical development plans, protocols and reports and SOPs where appropriate.
- To provide supervision, management and direction to the Development department and colleagues ensuring operational excellence
- To host client audits on behalf of the development function
- To set and monitor the use of development budgets for studies. Provide input into preparation of annual departmental budgets and pay rises.
- Attendance at study specific meetings and calls as required.
The successful candidate will have a relevant Degree in Science or higher qualification with considerable experience in a development role within the pharmaceutical industry. We are looking for a talented technical leader who thrives in a fast-paced working environment. Excellent interpersonal skills are key for this role as you will lead the Development team, collaborate with other departments and interact with sponsors on a daily basis.
Other skills and experience required:
- Extensive supervisory experience in a Pharmaceutical R&D laboratory
- Knowledge of procedures, processes and systems for a cGMP compliant pharmaceutical development laboratory
- Expertise in product development, validation and troubleshooting
- Extensive knowledge of product development requirements for oral, parenteral and inhaled dosage forms
- Experience in hosting and responding to QA and client audits
- Cross-functional experience and awareness of early Pharmaceutical / Clinical Development
- Understanding of CTA process and experience of compiling IMPD submissions
- Experience in a client-facing role
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.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.