US ~ Boothwyn, PA
Our growing and successful business comprises of over 700 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, specializing 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.
- Develop stable and bioavailable pharmaceutical dosage forms. Develop and optimize manufacturing processes and manufacture clinical supplies.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Responsible for developing formulations and manufacturing process for pharmaceutical dosage forms to meet customer needs.
- Perform pre-formulation, formulation, manufacturing process development/optimization for various batch sizes (lab to production scale), and equipment and process validation under strict cGMP guidelines.
- Prepare and review SOPs, batch records, protocols, development reports.
- Prepare and monitor stability protocols per ICH guidelines. Evaluate stability results of formulation prototypes and clinical supplies.
- Evaluate packaging components.
- Plan project activities with the supervisor.
- Interact and coordinate project activities with analytical scientists and QA.
- Report results of the experiments to the supervisor in a timely fashion.
- Train new employees.
ADDITIONAL POSITION REQUIREMENTS
- 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
- providing overtime as needed
- Learning new skills, procedures and processes.
- Is available for other duties as required.
- Is available for overtime as needed.
EDUCATION and/or EXPERIENCE
- M.S. Degree in Chemical Engineering/Pharmacy/Pharmaceutical Sciences or other related field or; B.S. degree in Chemical Engineering/Pharmacy/Pharmaceutical Sciences or other related field plus 3-8 years experience in the pharmaceutical industry.
- Spray drying experience is preferred
- Read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedure manuals.
- Write routine reports and business correspondence and standard operating procedures manuals.
- Work with mathematical concepts such as probability and statistical inference.
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
- Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, corollary techniques, sampling theory and factor analysis.
- 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.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Knowledge of chemical concepts and theories.
- Familiarity with the production process.
- Familiar with a variety of laboratory equipment, such as dissolution apparatus, HPLC, KF, etc.
- Successfully completes regulatory and job training requirements.
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to perform under stress in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment.
- 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.