732-661-0400

Senior Analytical Chemist – Research and Development

  • Location: Fort Worth
  • Type: Direct Hire
  • Job #36676

Exciting new opportunity with a rapidly growing pharmaceutical manufacturing company that specializes in product development, microbiology services, packaging, distribution, and more. Looking for someone with experience in R&D Development with tablets, solutions, suspensions and semisolids in pharmaceuticals. Some nutraceutical is helpful. The right candidate will need to be able to think through methods and develop/troubleshoot, and mentor people.

Local to Fort Worth, TX as a Direct Hire opportunity, the Sr. Analytical Chemist is responsible for analytical method development and validation for semi-solid topicals and solid and liquid oral prescriptions, dietary supplements, medical foods, and more. As a Sr. Analytical Chemist, you will perform job related duties in a safe, organized, and efficient manner to ensure all project requirements are met. This position is perfect for an established analytical scientist that is eager to continue growing within the pharmaceutical field, focusing on experience in HPLC, FTIR, UV-Vis, Karl Fischer titration, gas chromatography, and atomic absorption spectrometry, dissolution testing and advanced knowledge and understanding in chemistry and chemical analysis. You should have your Bachelors in Chemistry, Pharmaceutical Sciences, Chemical Engineering or related with 5 or more years’ experience within the pharmaceutical industry.

Schedule: 8am-5pm, Monday-Friday

Salary:$85K+++ DOE 

Essential functions of the job include but are not limited to:

  • Develop new analytical methods for new product formulations for liquid and solid oral-dose delivery systems and semi-solid topical dosage forms of pharmaceuticals and dietary supplements for strength, impurities, identity, potency, and dissolution by HPLC, GC, spectroscopy, and compendial testing. Calibrate & Troubleshoot equipment.
  • Quickly evaluate, develop, and optimize analytical testing methods for early phase development projects and proof of concept samples.
  • Write and execute analytical method validation protocols according to USP and ICH requirements and test methods and write method validation reports.
  • Provide training, direction, and mentorship to other analytical scientists in the team.
  • Analyze development prototype stability samples with developed analytical methods and report results.
  • Work closely with R&D formulation team to ensure that key product requirements QTPP and CQA are identified and delivered for each product. Set product specifications based on product QTPP and CQA and analytical results and regulatory requirements.
  • Observe and recognize deviations in results that could lead to inaccuracies; make remedies to assure reliable and accurate results and reporting.
  • Provide timelines for analytical method development and validation for new projects and prioritize work.
  • Write SOPs and other technical documentation as required.
  • Influence purchase of laboratory supplies and capital equipment.
  • Develop finished product and process specifications for new and/or existing products.

QUALIFICATIONS/EDUCATION:

  • Bachelor’s Degree-(or higher) Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline with 8+ years of relevant industry working experience including 5 years in pharmaceutical chemistry
  • Proficient in analytical method development for multiple semi-solid, solid, and liquid dosage forms and troubleshooting as well as method validation, writing and executing method validation protocols and reports.
  • Experience with HPLC method development of dosage forms containing multiple active ingredients and preservatives. Experience in wet chemistry, HPLC, FTIR, UV-Vis, Karl Fischer titration, gas chromatography, and atomic absorption spectrometry, dissolution testing and advanced knowledge and understanding in chemistry and chemical analysis.
  • Experience with writing deviations, and non-conformance investigations, root cause analysis, and providing corrective action for out-of-specification results.
  • Experience with pre-formulation studies, solubility screening, excipient compatibility and stability testing.
  • Experience with ANDA, NDA, or IND filings and QbD principles including method validation protocols and reports, and experience with FDA deficiency responses helpful for future business model.
  • Thorough knowledge of cGMP and cGDP and working knowledge of ICH, USP/NF, and FDA regulations. Experience working with controlled substances and knowledge of DEA regulations and requirements, providing physical inventory, sample control and tracking.

**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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