Analytical Scientist II (QC)

Quotient Sciences

Quotient Sciences

Garnet Valley, PA, USA
Posted on Tuesday, June 4, 2024

Analytical Scientist II (QC)

Garnet Valley, PA 19014, USA Req #211
03 June 2024
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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures,
fast. Because humanity needs solutions, fast.

The Role

The Analytical Scientist II is responsible for analytical method development, validation, and transfer activities under the supervision of the Senior Group Leader. This includes formulation development such as material characterization, API/raw materials sampling, cleaning verification, and technical writing.

Main Tasks and Responsibilities

  • Operates and troubleshoots the following instruments and equipment to test and evaluate pharmaceutical samples
    • HPLC/UPLC, dissolution apparatus, Karl-Fischer water content titrator, GC, FTIR, UV, and any other instruments as directed
  • Follows analytical testing methods, compendial methods, experimental procedures, and SOPs
  • Conducts release and stability testing for drug product in the QC laboratories
  • Documents test results in laboratory notebook, in real time, and communicates status of test results to supervisor
  • Peer reviews laboratory notebooks for technical details
  • Maintains control of all project- related pharmaceutical samples submitted to the laboratory as they can contain potent and/or hazardous components
  • Performs cleaning and housekeeping duties to ensure the laboratory is continuously maintained in a safe and orderly condition
  • Collaborates with supervisor regarding sample preparation, instrument performance, data acquisition, and analysis
  • Supports department LIRs, Deviations, CAPAs, Change Controls and SOP updates as needed
  • Trains on all SOPs and company procedures and remains current with training curriculum

The Candidate

Knowledge: The factual and procedural information required to perform the role

  • Bachelor’s degree in Chemistry or other related field of study with 3+ years’ experience in an Industrial Pharmaceutical Laboratory
  • Master’s degree in Chemistry or other related field of study with 1+ years’ experience in an Industrial Pharmaceutical Laboratory
  • Ph.D. with 0-2 years’ experience in an Industrial Pharmaceutical Laboratory
  • In lieu of a of a Ph.D. degree in Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field, or foreign degree equivalent plus two (2) years of experience in the pharmaceutical industry, the employer will accept a Bachelor’s degree in the same fields, or foreign degree equivalent plus three (3) years of experience in the pharmaceutical industry
  • Knowledge of federal and state regulations and guidelines including FDA, EPA, OSHA, and DEA
  • Knowledge of all company and site policies and procedures
  • Knowledge of commercial laboratory safety procedures, precautionary laboratory measures, and GMP Manufacturing procedures

Skills: The effective use of knowledge and abilities in performance.

  • Proficiency in Microsoft Office required
  • Proficiency in experiment documentation and basic laboratory skills
  • Use instruments, equipment, and technology safely and effectively
  • Able to work in a hazardous environment with a high requirement to follow safety procedures
  • Proficiency in HPLC and dissolution
  • Proficiency with Chromatographic data systems (CDS) such as Empower

Abilities: Innate traits or talents a person possesses

  • Good communication skills with the ability to effectively document testing process and report information to supervisor
  • Good time management skills with the ability to ensure accurate and timely data reports
  • Good writing skills with the ability to document and explain findings
  • Good analytical skills with the ability to understand and analyze data
  • Commitment to continuous education to remain in current profession and industry trends, make suggestions for new improvements, and learn new skills, procedures, and aspects of formulation and development

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

Other details

  • Pay Type Salary