US ~ Garnet Valley, PA
Senior Associate Formulator
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.
Conduct formulation development and manufacturing related activities.
Comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- Conduct lab work as planned by the supervisor that involves development of pharmaceutical formulations such as tablets, capsules and liquids.
- Conduct pharmaceutical manufacturing of oral dosage forms using small to large scale equipment for development and process scale up and for clinical supplies.
- Review and write master batch records with input from supervisor. Prepare executed batch record folders.
- Comply with cGMPs, SOPs and Company policies.
- Review and write SOPs and validation protocols.
- Maintain planned training schedule and record.
- Completion of clinical batch manufacturing as per timeline.
- Ability to perform physical work while using a respirator.
- Other activities as directed by supervisor, or as described in the QS Pharma Employee Manual.
- Train new employees.
- 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.
- Performs housekeeping to assure the laboratories and manufacturing areas are continuously maintained in a safe and orderly condition.
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- making suggestions for improvement
- Learning new skills, procedures and processes.
- Is available for other duties as required.
- Is available for overtime as needed
- Include Cross Training
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 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, stoop, kneel, crouch or crawl and taste or smell.
- The employee must occasionally lift and/or move up to 40 pounds.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
- Must be able to qualify for respiratory protective equipment use
- B.S. Degree in Chemical Engineering, Pharmacy/Pharmaceutical Sciences or other related field with 2-3 years’ experience in the pharmaceutical industry or appropriate combination of education and experience
- Minimum 1-2 years’ experience in Solid dosage formulation and development and clinical manufacturing (tablet, capsule)
- Read and interpret documents such as batch records, SOPs, policies, and safety rules, read and write business correspondence
- Define problems, collect data, establish facts and draw valid conclusions.
- Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Basic knowledge of physicochemical concepts and theories.
- Familiarity with the production process.
- Familiar with a variety of in-process equipment, such as disintegration, friability, particle size, etc.
- Successfully completes 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
- Apply basic concepts such as fractions, percentages, ratios, proportions and significant figures to practical solutions.
- Work with basic statistical concepts such as average and standard deviation
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.