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Quality Control Chemist II-III

AmbioPharm,Inc. North Augusta, SC Full-Time
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Quality Control Chemist II


MAJOR RESPONSIBILITIES


Key responsibilities to include the following.


·       Work hands-on with HPLC, GC, IC, KF and other routine analytical equipment such as pH meter and balance.


·       Method development and method validation, including writing protocols and reports.  Must be proficient.


·       Responsible for reviewing analytical laboratory records.


·       Participate in out of specification (OOS) investigations, as well as other investigations, and writing investigation reports.


·       Perform and review QC stability and release testing.


·       Maintain the QC lab by ordering supplies routinely used for testing.


·       Assist the QC/QA group with writing and editing of SOPs and STPs.


·       Support OQ/PQ for the Quality Control equipment; troubleshoot equipment.


·       Train and oversee junior chemists for routine QC activities.


·       Other duties as assigned.



QUALIFICATIONS


The successful candidate will possess the following.

 

§  Master’s Degree in Chemistry or life sciences with 2-5 years of experience in a GMP environment, or Bachelor’s Degree in Chemistry or life sciences with 5-7 years of experience in a GMP environment.


§  Hands-on experience with HPLC/UPLC, GC, GC-MS/LC-MS, KF, IC.


§  Experience with MassLynx is desirable.


§  Hands-on experience with Empower and/or Chemstation is required. 


§  Familiarity with both CFR 21 and ICH guidelines in regard to GMP.


§  Computer skills in MS Word, EXCEL, and Access.


§  Effective communication skills (oral and written). 


§  Flexibility in working hours is required.


§  Supervisory experience is preferred.


§  Must be able to sit and stand throughout the day.


§  Must be able to lift a min. of 30 pounds at any given time throughout the day.


§  Must be able to wear a respirator in the lab areas as needed.


Recommended skills

Product Quality Assurance
Communication
Code Of Federal Regulations
Empower
Computer Literacy
Testing
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AmbioPharm, Inc. (APi) has developed a new business model responsive to an accelerating trend in our industry to drive down costs of manufacturing peptides. We are looking forward to becoming your manufacturing partner for your peptide projects from preclinical and clinical to commercial. Please allow us to introduce APi’s capabilities.

We have established a new custom peptide supply service designed to manufacture peptides rapidly and at the lowest possible cost for pharmaceutical and biotech companies. At your request, we will provide research-grade peptides for your pre-clinical in-vitro, medicinal and toxicology programs. This service will provide you with milligrams to multi-grams of research-grade peptides fully-qualified and released by our in-house Quality Control Department. We can perform solid-phase, solution-phase or hybrid peptide chemistry plus organic conjugations to proteins, toxoids, antifungals, KLH, and PEG .

When your peptide is ready for clinical studies, we will apply over 100 years of cumulative experience in manufacturing to your Pharmaceutical-grade peptide projects. Our manufacturing facilities have eight process development suites operating in parallel with multiple reactor vessels up to 1,000L (100kg crude peptide/batch) for solid-phase synthesis and solution reactors up to 5,000L (200kg crude peptide/batch). We maintain scalable HPLC purification systems up to 60cm (28kg pure peptide/batch) and multiple lyophilization systems up to 400L (30kg pure peptide/batch).

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