Senior Director​/Director - CMC​/GMP Quality Assurance

Semnur Pharmaceuticals, Inc. is a biopharmaceutical company focused on the clinical and commercial development of innovative products that meet the needs of pain management practitioners and their patients.

Back pain affects most adults, causes disability for some, and is a common reason for seeking healthcare. In the United States, opioid prescription for low back pain has increased, and opioids are now the most commonly prescribed drug class. More than half of regular opioid users report back pain. Rates of opioid prescribing in the US and Canada are two to three times higher than in most European countries.

Semnur’s lead program, SP-102 (SEMDEXA™), is the first non-opioid novel injectable corticosteroid gel formulation for patients with moderate to severe chronic radicular pain/sciatica, containing no preservatives, surfactants, solvents, or particulates. If approved by the FDA, SP-102 (SEMDEXA™) will be available in a pre-filled syringe formulation and will be administered as an epidural injection for the treatment of sciatica.

In the United States, Semnur Pharmaceuticals plans to develop and commercialize product candidates, either through its own efforts or in conjunction with partners. Outside of the United States, we anticipate commercializing these products through select regional partnerships worldwide.

Our primary focus lies in the development of non-opioid products for meeting the needs of underserved patients with back pain. We believe that the therapeutic advantages of our product and technology will improve products’ efficacy and safety making a substantial improvement in the treatment of back pain.

We are looking for an enthusiastic and talented Chemistry, Manufacturing, and controls (CMC)
-Good Manufacturing Practice (GMP) Quality Assurance candidate (CMC-GMP QA) who is experienced in the current good manufacturing practices (cGMP) related quality assurance, and who thrive on challenges and changes of Chemistry, Manufacturing and Controls area, who can roll up their sleeves, put on multiple hats and have a can-do attitude without a lot of oversight or instruction.

This is a Senior Director/Director, CMC/GMP Quality Assurance full time employment (FTE) position. The GMP QA candidate will report to the Chief Technical Officer, Chemistry, Manufacturing and Controls, Regulatory CMC, and Quality Assurance.

The GMP QA FTE candidate will support and work with Quality Assurance and Manufacturing or Analytical FTE or consulting staff in Department of Chemistry, Manufacturing, and Controls and GMP Quality Assurance (CMC QA Dept).

This GMP QA candidate support Chemistry, Manufacturing and Controls (CMC)’s Quality Assurance Compliance, Quality Management System, Quality Audits, Design Controls and external/3rd party manufacturing/contract manufacturing, and analytical testing of commercial products, combination product, and/or clinical products.

The GMP QA candidate will support supply chain, distribution, return and product quality complaints of commercial products, combination product and/or clinical products.

The successful candidate will support to write, review and/or approve chemistry, manufacturing and controls documents and tasks listed below and other documents and tasks, as required:

• standard operating procedures (SOP) of CMC Quality Management System and Quality Assurance and Quality compliance
• CMC quality audits
• product development records, manufacturing batch records (M /E ), process validation records (PV/PPQ), analytical records (AD/AV),
• release/disposition of GMP batches,
• supply chain/distribution records, product returns
• design controls (DC), design validation (DV), design history files (DHF) and…