US ~ Garnet Valley, PA
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Provide supervision to a portion of the Formulation Development Group and Clinical Supplies Manufacture, Packaging and Labeling at Quotient Sciences, Philadelphia facilities.
Ensure compliance and safety practices followed by the team during daily activities.
Main tasks and responsibilities will include:
- Formulate oral solid dosage forms in a fast-paced contract manufacturing environment.
- Participate in some discussions with existing & potential clients to ensure effective dialogue leading to a project at Quotient Sciences.
- Perform pre-formulation, formulation, manufacturing process development/optimization for various batch sizes (lab to production scale), and equipment troubleshooting and support process validation under strict cGMP guidelines, as required
- Directs and manages some projects to meet the agreed upon timelines and works closely with internal/external groups to meet all Client and Quotient Sciences technical milestones.
- Mange clinical supply manufacturing from Phase I-III under cGMP.
- Demonstrate scientific, technical proficiency in the area of Formulation Development, Scale up/ Tech. Transfer, Cleaning Verification and Clinical Supplies.
- Responsible for understanding and developing procedures for operational and equipment SOPs.
- Manage technical transfer of commercial scale process for Product intended for U.S., Europe, and Japan.
- Prepares/Reviews/approves development reports, manufacturing and packaging records, and SOPs.
- Leads or supports any Quality Investigations initiated by the team in a timely manner.
- Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- Making suggestions for improvement
- Learning new skills, procedures and processes.
- Attend client meeting regularly and update the client on time.
- Is available for other duties as required or assigned.
- Very high concentration of work
- Strict and tight 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
- While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and talk or hear.
- The employee is occasionally required to sit, reach with hands and arms, climb or balance, and taste or smell.
- The employee must occasionally lift and/or move up to 40 pounds.
- Must be able to qualify for respiratory protective equipment use.
- Ability to perform under stress in cases of emergency, critical or hazardous situations
- Computer skills and client correspondence
- M.S. in Chemical Engineering, Pharmacy/Pharmaceutical Sciences or other related field with minimum 2-3-year experience in the pharmaceutical industry; or a combination of training and education plus 5 -year experience in the pharmaceutical industry.
- Previous experience in leading the projects desirable.
- Familiarity with the production process.
- Familiar with a variety of manufacturing and in-process equipment
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.