Data Review Scientist Extractables Leachables

Eurofins USA BioPharma Services; Lancaster (Lancaster County); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading company in bio/pharmaceutical services is seeking an experienced analyst to conduct tests on pharmaceutical materials. The role involves working independently in a GMP lab setting, performing analyses, reviewing data, and providing training to newer analysts. Strong analytical skills, a Bachelor's in Chemistry, and 3 years of relevant experience are essential for success in this position.

Benefits

Excellent full-time benefits including comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Qualifications

• 3 years experience in a GMP lab setting is required.
• Good work habits (organized, efficient, careful).
• Ability to multitask and communicate effectively.

Responsibilities

• Perform various tasks and analyses of Bio/pharmaceutical ingredients.
• Conduct routine, non-routine, and complex analyses independently.
• Review laboratory data for accuracy and compliance with GMP/GLP.

Skills

Good dexterity

Attention to detail

Sound scientific logic

Good oral and written communication skills

Client service focused

Technical writing skills

Solution driven

Education

Bachelor's degree in Chemistry or related science

Tools

Chromatography

LC/MS

GC/MS

ICP systems

Job description

Job Description

Perform various tasks and analyses of Bio/pharmaceutical ingredients and products; reviewing/preparing standards and samples for analysis and running a variety of equipment or instrumentation independently; troubleshoot and solve instrumental and/or method problems; working efficiently; ensuring that client received quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP and/or GLP regulations; evaluate current systems and suggest process improvements when appropriate; write complete and detailed investigations independently; support multiple projects simultaneously; demonstrate leadership qualities and train newer analysts.

Extractables/Leachables:

** Background:** **** Bio/pharmaceutical container closure systems, delivery systems, and manufacturing components may contain additives that can leach into the final drug product. These leachable compounds may pose potential health risks to the patient by increasing the drug’s toxicity or reducing its efficacy.

** What do we do:** The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds. This process involves exposing the materials to extraction solvents and then testing the resulting extraction solutions by a variety of analytical techniques. These screening methods require extensive data interpretation in order to identify the compounds using proprietary databases.

Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Applies the highest quality standard in all areas of responsibility
• Demonstrates and promotes the company vision
• Demonstrates strong client service skills, teamwork, and collaboration
• Proactively plans and multitasks to maximize productivity
• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
• Regular attendance and punctuality
• Performs laboratory operations with good dexterity, good laboratory technique, and high degree of accuracy and precision
• Perform/review preparations of reagents, samples, and standards according to procedures.
• Perform routine, non-routine and complex analyses; instrumental analyses; including calibration and troubleshooting/repair of instruments independently
• Demonstrate the ability to multitask
• Perform all work independently
• Serve as a trainer for newer analysts
• Review/Document testing, observations, deviations, and results clearly and completely, and in compliance with regulatory requirements - striving to minimize errors
• Understand and perform calculations as required by test methods
• Understand and utilize computers for information access, calculations, and report preparation
• Read and understand analytical procedures (compendial and client supplied) and internal SOP's
• Demonstrate technical writing skills and initiate/support completing investigations
• Demonstrate desire to learn independently, including new analytical techniques and nonroutine analyses
• Demonstrate leadership qualities including;
  • Effective communication
  • Display confidence
  • Demonstrate motivation and take initiative
  • Follow through on assignments
• Process/review data, generate/review reports, and evaluate data
• Communicate effectively, both orally and in writing
• Independently seek out work
• Perform laboratory maintenance if required
• Support and drive LEAN initiatives
• Commitment to occasional overtime as workload requires
• Conducts all activities in a safe and efficient manner
• Ensures good housekeeping with a neat, clean and orderly workspace
• Performs other duties as assigned
• Communicates effectively with client staff members

Qualifications:
Qualifications

Minimum Qualifications:

• Bachelor's degree in Chemistry or related science
• 3 year experience in a GMP lab setting
• Authorization to work in the US without immediate or future sponsorship.
• Good dexterity
• Positive attitude
• Solution driven
• Good work habits (organized, efficient, careful, safety-conscious, accurate)
• Attention to detail
• Sound scientific logic; good oral and written communication skills
• Understanding of instrumentation and/or instrumental theory
• Client service focused
• Personal maturity
• Demonstration of organizational skills
• Ability to work with moderate supervision upon training completion on assigned task
• Ability to handle multitasking
• Technical writing skills

Additional Preferences:

• Experience operating chromatography
• LC/MS, GC/MS, and/or ICP systems.
• Experience with extractables and leachables testing
• Experience with wet chemistry
• Ability to work one of five days per week on the weekend

Additional Information

Working schedule will be Full-Time, First Shift, M-F 8am-5pm, weekend availability required. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. No relocation assistance will be given. This position is NOT remote.

What we Offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.