Senior CMC Leader (Formulations)
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.
- Responsible for CMC project development aspects - ensuring the provision of development plans and reports, protocol, specifications, and manufacturing records.
- Lead Technical representative on product development at the CMC project team
Main tasks and responsibilities will include:
- Responsible for the delivery of product development plans, product development reports and project updates, supporting the project set-up activities within Pharmaceutical Sciences
- Responsible for familiarizing the development team when a new project is launched
- Technical client-facing role, attending the project team meeting with the customer and leading the technical discussion
- Providing regular technical reports to the customer
- Responsible for establishing the basis of formulation and manufacturing process with relevant attributes and specifications as required to achieve the goal
- Ensuring provision of batch records to the manufacturing team
- Writing and review of analytical and formulation test protocols and reports
- Ensuring completion of development work and testing to deadlines
- May have to manage 1-3 CMC leaders
- Train, coach and mentor other CMC leaders and formulators
- Completion/Review of LIRs and QIs as appropriate
- Writing and updating SOPs
- Working with various functional areas to ensure completion of development and manufacturing activities
- Participate/lead cross-site product development activities
- Troubleshooting development issues
- Be current in formulation knowledge with respect to techniques and capabilities – esp in the area of poorly soluble drug formulations and modified-release products
- Good understanding of principles and practical knowledge of analytical techniques and formulation stability
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Degree in Chemical Engineering/Pharmacy/Pharmaceutical Sciences or other related field plus minimum 8 years' experience in the pharmaceutical industry
- Working knowledge of pharmaceutical development of oral dosage forms is a must
- Excellent technical writing and communication skills. A graduate degree with thesis/dissertation or scientific publication writing skills will be a plus
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 email@example.com.