Senior Group Leader, Associate Director, Formulation
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.
Responsible for directing and managing the Formulation Development and Clinical Supplies Manufacture, Packaging and Labelling at Quotient Sciences or at subcontractor facilities. Client interfacing role with keen attention to data interpretation from formulation sciences and pharmacokinetic studies. Manage a group of formulation scientists and GMP technical staff.
Main tasks and responsibilities will include:
- Participate in all initial discussions with potential clients to ensure effective dialogue leading to a project. Works closely with business and project management to provide client presentations, tours, preparation of development work plans, prepare/review proposals to support current clients and new business opportunities.
- Direct all the activities involving formulation development. Allocate personnel and resources to projects. Schedule project activities with other peers and plan the successful execution of timelines and deliverables.
- Directs and manages projects to meet the agreed upon timelines and works closely with Analytical R&D Group to meet all Client and technical milestones.
- Demonstrate scientific, technical and regulatory proficiency in the area of Formulation Development and Clinical Supplies. Demonstrates sound judgment, goal oriented actions and works in collaboration with others.
- Serves as Project Leader for assigned projects and acts as a technical liaison with Clients to provide written/verbal reports on progress or changes to Project plan.
- Develops and monitors performance plans and requirements for direct reports. Mentor direct reports to achieve and improve their performance for company and personal career growth.
- Develops and implements training programs for the department personnel.
- Prepares/Reviews/approves development reports, manufacturing and packaging records, SOPs and regulatory submission documents, specifications.
- Responsible for Quality of the work performed by the department.
- Solid knowledge of unit operations, cGMP, basics of analytical sciences, basic chemistry and biopharmacetuics.
- Assure development laboratory and GMP manufacturing area runs in a safe, clean, and environmentally sound manner in addition to maintaining detailed records for FDA, DEA and safety and environmental purposes.
- Oversee/approve the procurement, installation, validation and calibration of new or existing equipment and supplies to ensure reliable, prompt, precise and accurate work products.
- Assure that all work is performed in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Assure department complies with all company and site policies and procedures.
- Remain current in profession and industry trends.
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment and to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Ph.D in Pharmaceutics or related area with at least 6-10 years of pharmaceutical industrial experience with hands-on experience in formulation development and managing employees.
- Expert knowledge of Formulation Development and Clinical Supplies
- Proficient with a variety of production equipment and processes
- Familiarity with a variety of laboratory equipment, such as GC, HPLC, KF, dissolution, etc.
- Read, write and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedures.
- Write reports and business correspondence.
- Successfully complete regulatory and job training requirements.
- Computer skills:
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems
- Ability to perform under stress in cases of emergency, critical or hazardous situations
- Ability to work with others in a team environment
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.