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.
Under the direction of the Department Head, the incumbent is responsible for leading assigned Product(s) intended for Commercial manufacturing through Technology Transfer, Process Validation, and Cleaning Validation in a timely and compliant manner.
The Core functions of the Process Engineer (PE) will include the following –
- Scale-up of the manufacturing process prior to Registration Batches, leading to Process Validation and Commercial launch.
- Designing the manufacturing process with focus on Commercial manufacturability and ensuring a smooth technology transfer of process from phase III clinical to Registration to Commercial launch.
- Work in close association with Commercial manufacturing, Supply Chain, QA, and QC to ensure timely launch of products
- Comply & adhere to CGMP & GDP guidelines and regulations as required of this role.
- Responsible for ensuring compliance through Compliance Wire, KnowBe4, Veeva, and other training medium provided by Quotient, and follow procedures that govern the work performed in this role.
- Technical writing such as (but not limited to) protocols, reports, risk assessments, memorandum, investigations, APR, MBR, statistical analysis, and other documentation.
Main tasks and responsibilities will include:
- Perform scale up development and optimization of manufacturing process based on regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10).
- Collaborate with formulators and/or clients, Commercial manufacturing management and technicians regarding the design and execution of pilot and commercial process parameters, creation of formulation spread sheets, master batch record writing, batch execution, and post batch evaluation and analysis.
- Executes design of experiments (DOE) at lab scale and commercial scale by implementing quality by design (QbD) principles to develop robust process parameters.
- Review batch records, investigation reports, change controls, market complaints, annual product review, product development protocols and reports, drug master files, validation documents, equipment qualification reports, stability data, raw material data trend, CAPAs, in process and finished product analytical data to gain the product and process knowledge and identify the risks to the quality of the product.
- Communicates to management an overview of assigned products.
- Ensures compliance with all aspects of CGMP.
- Prepare, approve & execute all necessary documentation, reports, protocols, batch records, etc. as required.
- Perform process improvement projects and troubleshoot production processes.
- Perform other duties as assigned.
- Presentation skill.
- Clear Communication skill (Verbal and written).
The job may involve the following:
The job involves the following:
- Very high concentration of work at times and at regular intervals
- Strict and tight agreed upon deadlines
- Having to juggle on various 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
- Organizational skills
- Basic Computer skills
- Ability to take appropriate actions in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment.
- Attention to detail
- Attend client meetings and generate orderly meeting timelines
- Bachelor's Degree in Pharmacy, Chemical Engineering, Sciences or its equivalent.
- Minimum of 1 year experience in a GMP manufacturing environment of Oral Solid Dosage forms in a CDMO, Generics, Nutraceuticals or Brand organization
- Knowledge of Scale-up principles and statistical controls.
- Exhibits strong process development skills and must be a quick learner.
- Manages projects to deliver results on time.
- Proficient in Process Safety concepts and methodology.
- Focused on Meeting Customer Needs
- High degree of professionalism, ethics, and integrity
- Incumbent must be able to be accountable for own actions and complies with the laws and company policies.
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.