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.

Role and Responsibilities:

Senior Director/Director, CMC/GMP Quality Assurance:

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 (MBR/EBR), 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 risk assessments
• investigations of deviations, out of specifications (OOS) and temperature excursions, during manufacturing and analytical testing and shipments,
• investigations of deviations/temperature excursions during shipments and storage
• pre-approval inspections (PAI) and GMP inspections at Contract Manufacturing Organization or Contract Manufacturing Development Organizations (CMOs or CDMOs) and Device area for DC/DV/DHF
• CMC regulatory submissions to CDER and CDRH and other agencies

The ideal FTE candidate would have been in a Senior Director/Director of GMP Quality Assurance position and experience from a prior Pharmaceutical or Biotech company with strong records of accomplishments in quality management system, quality assurance, quality audits, pre-approval and GMP inspections and quality assurance aspects for small molecule or biological

injectable products’ Commercial Product Manufacturing, Combination Product Manufacturing or Late-stage Clinical Product Manufacturing either in-house/1 st party/2 nd party and/or at a 3rd party/CMO or CDMO.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Support, follow and maintain GMP quality assurance, quality management systems and policies, and SOP related to Part 210,Part 211 and Part 820.

Contribute to Quality Compliance and Quality Management of manufacturing of raw materials, drug substance, drug product, and labeling, package inserts, and packaging and distribution of commercial products, commercial products and clinical products, as required.

Contribute to CMC Quality Assurance oversight of CDMOs or CMOs, Contract Laboratories, 3rd Party Logistics (3PL) providers/distributors/shippers and other vendors used for commercial or clinical product manufacturing or testing, as required.

Contribute to review of formulation development, method development, as required.

Support preparation/review of documents of PAI and GMP inspections at CMO and/or CDMO, as required.

Contribute to review of MBRs and EBRs, PV, AV, PPQ, CPV and perform final product release/stability/disposition, quality control, COA, as required.

Support SAT/FAT for manufacturing equipment, as required

Contribute to devise controls/DC, design verification/DV, risk management, design history files/DHF for combination products

Support investigation and resolution of product complaints and damaged products with external party and that commercial or investigational product complaints are investigated to ensure compliance, as required.

Contribute to supply chain, logistics and return products disposition/destruction with 3PL, as required.

Support review and approval of investigation, deviations, OOSs/OOTs, Change Controls, CAPAs and any other related quality records, as required.

Support writing/review/approval of policies and SOP related to CMC and QA, as required.

Contribute to audit agenda/reports, product specifications, test methods, qualification/validation protocols and reports, stability protocols/reports, as required.

Support GMP audit activities at DS and DP contract manufacturers including establishing audit schedules, conducting audits, audit report writing/review, and close out audits, as required.

Contribute to internal and external audit programs including vendor qualifications and routine or for cause audits and inspection readiness at CDMO/CMO, 3PL, and Vendors.

Support writing/review/approval of GMP documentation, SOP, quality agreements (QA), manufacturing services agreements (MSA) with CMO or CDMO , as required.

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

To perform this role successfully, an incumbent must be able to perform each essential role and responsibility satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required for this position and may change on a need basis.

Minimum bachelor’s degree in relevant scientific or engineering discipline or equivalent.

Minimum of 15 + years of CMC/GMP Quality Assurance (GMP QA) and QMS related prior experience in commercial injectable product manufacturing, combination injectable product manufacturing or clinical injectable product manufacturing and design controls at a Pharmaceutical or Biotechnology Company.

Prior experience in

• Quality Management Systems, Quality Compliance, Quality Audits and Design Controls for commercial product/combination product pipelines is a must.
• Quality Management Systems, Quality Compliance, Quality Audits and Design Controls for clinical product pipelines is a plus
• FDA pre-approval inspections and GMP inspections is a must.
• CMC QA experience with commercial combination products is a must
• Review/authoring of CMC reports and associated regulatory filings to FDA-CDER-NDA (Part 210/211) and FDA-CDRH-PMA (Part 820) is a must
• Quality Compliance for Aseptic Product Manufacturing, Combination Injectable Product Manufacturing, and/or Process Performance Qualification and Analytical Testing of commercial injectable products or late stage clinical products is a must
• Design control, design verification, risk management and design history files for combination injectable products is a must
• Working with CDMO, vendors, and 3PL-supply chain/distribution/return of commercial products is a must
• Working with CMO, vendors, and 3PL-supply chain/distribution/return of late stage clinical products is a plus
• Review/authoring of CMC reports, Design Controls and Device reports and associated regulatory filings to FDA-CDER-NDA (Part 210/211) and FDA-CDRH-PMA (Part 820) is a plus

Knowledge of cGMP, ICH Guidelines, FDA CDER, and FDA CDRH Regulations, ICH Guidelines and Iso Guidelines for drug substance, drug products, injectable drug products, combination products, and/or medical devices is required, as applicable.