Scientist II- Chemistry Lab Trainer

Extractables & Leachables Testing:

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 drugs 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.

Center of Focus: 

• Extractables team members will perform worst case extractions on various materials and then test the resulting extraction solutions to determine what compounds may be extracted out of the materials under exaggerated conditions
• Leachables team members will test drug product that has been stored in the container closure system to determine what compounds will leach out of the materials and into the drug product under the actual conditions of use.
• Development and Validations team members will establish method conditions that meet the intention of the analytical method and then perform a series of tests (e.g. precision accuracy linearity specificity and sensitivity) to ensure the method is appropriate for its given function.
• Unknown Peak Identifications team members will perform investigative testing in an effort to identify unknown compounds.  This testing typically relies on mass spectrometers that are capable of fragmenting the unknown compound.

Instrumentation and testing techniques:  Liquid Chromatography Mass Spectrometry (LC/MS) including Time-of-Flight (TOF) Quadrupole Time-of-Flight (QTOF) and Triple Quad (MS/MS) LC/MS systems; Headspace and Direct Injection Gas Chromatography Mass Spectrometry; High Performance/Ultra High Performance Liquid Chromatography (HPLC/UPLC); Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES); Inductively Coupled Plasma Mass Spectrometry (ICP/MS); Microwave Digestion; Various Laboratory Equipment (including balances pH meters sonicators and centrifuges). 

Qualifications :

Minimum Qualifications:

• Bachelors degree in Chemistry or related scientific degree
• 3 years laboratory experience
• Ability to work in the US without immediate or future sponsorship
• Extensive experience training others and/or setting up formalized training programs
• Experience operating chromatography LC/MS GC/MS and/or ICP systems
• Experience with extractables and leachables testing 
• Experience with wet chemistry 
• Experience in a GMP or ISO 17025 accredited lab setting.

Additional Information :

Working schedule will be Full-Time First Shift M-F 8am-5pm. Some weekends required when necessary. Candidates currently living within a commutable distance of Lancaster PA are encouraged to apply. 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.

Remote Work :

No

Employment Type :

Full-time