Manufacturing Operator

at  Quotient Sciences

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 help biotech and pharma customers save precious time and money in getting drugs to patients.
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 that’s focused on innovation and are 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
The Manufacturing Operator is responsible for manufacture of Investigational Medicinal Products to produce solids (Capsules and tablets), liquids, creams, gels and inhalation dosage forms for use in development or clinical trial studies. They will support transfer of processes from development into clinical trial manufacturing and preparation for manufacturing campaigns.
Also responsible for tasks associated with the upkeep of a GMP Cleanroom Facility, including, but not limited to: the routine cleaning of manufacturing and storage facilities in accordance with cleaning regime during routine facility cleaning, cleaning in between batch manufacturing and at the end of campaign manufacturing activities.

Main tasks and responsibilities

• Manufacture of pharmaceuticals to Good Manufacturing Practice (GMP) standards and internal Standard Operating Procedures (SOP) and associated laboratory activities whilst adhering to Good Documentation Practice (GDocP).
• Direct involvement in tasks associated with the running and maintenance of the GMP cleanroom, including room set-up for manufacturing activities and cleaning of required equipment and consumables. Complete weekly workloads based on the schedule of Clinical Manufacturing and Development activities provided by the Head of Production (HOP) or nominated deputy.
• Preparation of working BMRs, checked working labels, processing rooms, equipment, consumables, cleaning documents, swabbing procedures and COSHH (as appropriate) prior to onset of manufacturing operations.
• Ensuring that manufacturing/validation procedures are carried out as per approved manufacturing/validation protocols in a reproducible manner with the minimum number of avoidable errors. Adhering to the KPI target set by the Head of the Department.
• Working in a safe responsible manner at all times.
• To communicate progress of development and clinical trial manufacturing projects effectively to the Head of Production (HOP), QA and Project Management teams as required, to allow realistic goals to be set and to allow clients to receive timely information on project achievements or issues arriving.

Qualifications and experience required for competent performance

• Some work experience (GMP/GLP) in similar type of work
• Excellent interpersonal and communication skills
• Excellent organizational, problem solving and follow up skills
• Ability to perform multiple tasks and prioritize effectively
• Excellent attention to detail

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

• Manufacture of pharmaceuticals to Good Manufacturing Practice (GMP) standards and internal Standard Operating Procedures (SOP) and associated laboratory activities whilst adhering to Good Documentation Practice (GDocP).
• Direct involvement in tasks associated with the running and maintenance of the GMP cleanroom, including room set-up for manufacturing activities and cleaning of required equipment and consumables. Complete weekly workloads based on the schedule of Clinical Manufacturing and Development activities provided by the Head of Production (HOP) or nominated deputy.
• Preparation of working BMRs, checked working labels, processing rooms, equipment, consumables, cleaning documents, swabbing procedures and COSHH (as appropriate) prior to onset of manufacturing operations.
• Ensuring that manufacturing/validation procedures are carried out as per approved manufacturing/validation protocols in a reproducible manner with the minimum number of avoidable errors. Adhering to the KPI target set by the Head of the Department.
• Working in a safe responsible manner at all times.
• To communicate progress of development and clinical trial manufacturing projects effectively to the Head of Production (HOP), QA and Project Management teams as required, to allow realistic goals to be set and to allow clients to receive timely information on project achievements or issues arriving