Process Analytical Support GMP Analyst

3 weeks ago


Malvern, United States Eurofins USA PSS Insourcing Solutions Full time

Job Description

Perform routine cGMP testing of samples for biopharmaceutical clients in a BSL-2 laboratory which may include HPLC, SEC, CE-SDS, cIEF, MDI/MFI, GC, UV-VIS spectroscopy (A280 and SoloVPE), oligosacharride mapping, turbidity, and/or osmolality

• Conduct analysis and reporting of data in accordance with requirements set forth by the department in electronic notebooks.

• Apply GMP/GLP in all areas of responsibility, as appropriate

• Provide training for other analysts

• Demonstrate strong client service skills, teamwork, and collaboration

• Meet all quality and productivity metrics and demonstrates strong teamwork and collaboration

• Troubleshoot assay or instrumentation problems

• Work on a team consisting of 10 analysts

• Perform other duties as assigned

Qualifications: Qualifications

Bachelor’s or Master’s degree in a related science (chemistry, pharmacy or equivalent sciences degree), or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full time year if college in related major)

• Familiarity with GMP/GLP or prior work experience in a GMP laboratory

• Excellent communication skills (oral and written)

• Experience with Empower software is strongly desired

• Strong computer, scientific, and organizational skills

Experience with protein analytics, including, but not limited to are preferred but not required:

high pressure liquid chromatography (HPLC)

capillary electrophoresis (cSDS)

spectrophotometry absorbance (A280)

capillary isoelectric focusing (cIEF)

Familiarity with GMP requirements and Good Documentation Practices

Ability to troubleshoot instrumentation as needed.

Experience with Empower software strongly desired.

Additional Information

Position is full-time, Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.

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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Qualifications

Bachelor’s or Master’s degree in a related science (chemistry, pharmacy or equivalent sciences degree), or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full time year if college in related major) • Familiarity with GMP/GLP or prior work experience in a GMP laboratory • Excellent communication skills (oral and written) • Experience with Empower software is strongly desired • Strong computer, scientific, and organizational skills

Experience with protein analytics, including, but not limited to are preferred but not required:

* high pressure liquid chromatography (HPLC) * capillary electrophoresis (cSDS) * spectrophotometry absorbance (A280) * capillary isoelectric focusing (cIEF) * Familiarity with GMP requirements and Good Documentation Practices * Ability to troubleshoot instrumentation as needed. * Experience with Empower software strongly desired.

Additional Information

Position is full-time, Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.

* 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.**

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