Senior Manager, Technical Services & Validation
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.
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.
- Working closely with the Head of Department, the Senior Manager, Technical Services & Validation will be responsible for the following three core areas of job responsibilities.
- Managing assigned junior staff with their work assignments.
- Leading the assigned Technology Transfer, Process Validation, Cleaning Validation, Continuous Process Verification and Product Robustness of potential Product(s).
- Develop and maintain Departmental Standard Operating Procedures.
Main tasks and responsibilities will include:
- Technical writing such as (but not limited to) protocols, reports, memorandum, SOPs, quality incidents and their investigations, APR, MBR, change controls and other regulatory documentation in a timely manner, and being the source of knowledge of the Product(s) as its Subject Matter Expert.
- Author and review of documents, verifying data, input of data, statistical analysis & interpretation, processing quality investigation close outs.
- Design batch records, ETPs and GMP protocols as needed.
- Support Tech Services with training material required to bring the competence level of junior staff to departmental expectation.
- To comply & adhere to cGMP & GDP guidelines and regulations as required of this role.
- Responsible for ensuring compliance of department above 95%.
- Responsible for the design of DOE studies to establish foundation for future CPV efforts.
- 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 FD formulators 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 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.
- Communicates to management on all overview of assigned products.
- Ensure that junior staff are well equipped and supported to execute their assignments in a timely and successful manner.
- 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
- Minimum of a bachelor’s degree in Pharmacy, Chemical Engineering, Sciences or its equivalent.
- Minimum of 5 years managing technical staff in a fast phase environment.
- Minimum of 15 years working in Technical functions such as Technical Services, Process & Cleaning Validation and Continuous process verification & Product Robustness.
- Exhibits excellent process development skills and must be a quick learner. Must be capable of training and mentoring junior staff.
- 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.