Process Formulation Engineer/Scientist
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 work of the Process Engineer/ Process Scientist (PE/PS) will include scale up of the manufacturing process prior to Registration Batches, leading to Process Validation and Product launch. Towards this PE/PS is expected to have a strong technical and formulation understanding of OSDs, technical writing skills such as (but not limited to) protocols, reports, risk assessments, memorandum, investigations, APR, MBR, statistical analysis, and other documentation in a timely manner. The PE/PS will be the source of knowledge for the assigned Product(s) as will be its SME.
- This PE/PS will be responsible towards designing the manufacturing process with focus on Commercial manufacturability and ensuring a smooth transfer of product from phase III clinical to Commercial launch. Towards this, this PE/PS will work in close association with Commercial manufacturing, Supply Chain, QA, and QC to ensure timely launch of products
- The PE/PS will support commercial manufacturing with training material and exposure to the process, will lead with the MBR design & associated documentation as needed.
- The PE/PS will comply & adhere to cGMP & GDP guidelines and regulations as required of this role.
- The PE/PS will be 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.
Main tasks and responsibilities will include:
- Responsible for the design of DOE studies to establish foundation for future CPV studies.
- Perform scale up development and optimization of manufacturing process based on regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10). Understand formulation as required for appropriate SUPAC level changes and recommend formulation changes or studies as needed.
- Collaborate with FD 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.
- Prepare and monitor stability protocols per ICH guidelines where applicable for multiple market needs. Evaluate and trend stability results of SUPAC level changes and commercial products.
- Executes experiments at lab scale and commercial scale to implement the use of quality by design (QbD) principles and design of experiments (DOE) to develop robust process parameters. Design the experiments using statistical software.
- Evaluate retrospective quality by design (QbD) assessments of currently marketed products to improve quality, efficiency and mitigate potential cGMP and quality risk.
- Review batch records, incident investigation reports, change controls, market complains, 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 for understanding the process knowledge and identify the risks to the quality of the product.
- Communicates to management on all overview of assigned products.
- Ensures compliance with all aspects of cGMP’s.
- Prepare, approve & execute all necessary documentation, reports, protocols, batch records, etc. as required.
- Perform process improvement projects and troubleshoot production processes.
- Review SOPs and performance goals to ensure they reflect a commitment to quality and efficiency.
- NLT 95% compliance at a minimum in all training required to conduct the job.
- Perform other duties as assigned.
- Presentation skill.
- Clear Communication skill (Verbal and written).
The job may involve the following:
- Very high concentration of work at times and at regular intervals
- Strict and tight agreed upon 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
- 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 3 years as Process Engineer/Scientist experience in a cGMP manufacturing environment of OSD in a CDMO, Generics, Nutraceuticals or Brand organization.
- Must be experienced with scale-up and statistical process control, and process flow diagrams.
- Understand and capable of working with Formulation and how it relates to Process development.
- Exhibits strong process development skills and must be a quick learner.
- Manages projects to deliver results on time and on budget.
- 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 firstname.lastname@example.org.