Quotient Sciences: Molecule to Cure. Fast.
We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform,
Translational Pharmaceutics®, shortens timelines by 9–12 months on average.
Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling—streamlining early development from candidate selection to proof of concept.
Why join us?
Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.
Summary Of Job Purpose
Working within the Manufacturing Operations team, you will be responsible for co-ordinating and implementing all documentation activities required for pharmaceutical development, CMC, clinical trial manufacturing, IMS co-ordination and IMP labelling. You will support the Head of Manufacturing in ensuring that product and process development, and manufacturing activities for Investigational Medicinal Products (IMPs) are delivered on time and to the highest quality and regulatory standards.
Key Responsibilities
- Ensure batch manufacturing records, IMP labels, raw material requirements, study-specific specifications and training packs are in place prior to Familiarisation/Confirmation, CMC and clinical trial manufacture.
- Maintain regular communication with Production, Development, Supplies, Regulatory, Quality and Project Management teams.
- Bridge knowledge gaps and facilitate information transfer between Development and Production, and between Clinic and Production teams.
- Order and track study-specific equipment and consumables.
- Progress write-ups to status 4 prior to regulatory submissions.
- Create Drug Product Specifications (DPS), raw material and intermediate specifications on the Materials Management Database (MMD).
- Train the manufacturing team in study-specific batch manufacturing record use and completion.
- Communicate project progress effectively to the Head of Production, QA and Project Management teams to ensure realistic goals and timely client updates.
- Perform Quality Issue and Root Cause Analysis investigations and propose CAPAs for continuous improvement.
- Lead CTM Readiness meetings and attend key study-specific meetings, including Pharm. Sci. Kick-Off and CMC Readiness.
- Author and maintain documentation associated with the manufacturing department (work instructions, cleaning documents, SOPs).
- Support GMP cleanroom operations and ensure readiness for manufacture in terms of consumables, materials and equipment.
- Review and approve documentation required for pharmaceutical development, CMC, clinical trial manufacturing and IMP labels.
- Line manage direct reports, providing coaching, development opportunities and regular performance reviews.
- Perform GMP Operator duties when required.
- Undertake other reasonable duties as directed by the Line Manager.
Qualifications & Experience
- Degree-level qualification in a science subject and relevant work experience; OR
- Minimum 3 years’ experience within pharmaceutical production/GMP cleanroom or CMC Product Development environment.
Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not 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 applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
