CMC/GMP QA Consultant at Semnur Pharmaceuticals, Inc.

Palo Alto, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Jun, 26

Salary

125.0

Posted On

17 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP, Quality Assurance, CMC, Quality Management System, Quality Audits, Regulatory Submissions, Batch Records Review, Process Validation, Deviation Investigation, OOS Investigation, SOP Authoring, Vendor Qualification, Injectable Products, Aseptic Manufacturing, Design Control, Risk Management

Industry

Biotechnology Research

Description

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. Salary Range: $90-$125/hourly This is a 100% on-site position in Palo Alto, CA. Please note that moving expenses and relocation assistance are not provided for this position. 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. CMC/GMP Quality Assurance Consultant (40 hour/week): We are looking for an enthusiastic and talented Good Manufacturing Practice Quality Assurance consultant (GMP QA consultant) 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. The GMP QA Consultant candidate will report to the Chief Technical Officer and support Chemistry, Manufacturing and Controls (CMC) related Quality Management System, Quality Assurance Compliance, Quality Audits, and external/3rd party manufacturing and supply chain of commercial and/or clinical drug products. The GMP QA consultant will support and work with Quality Assurance staff in CMC Department like Senior Director, Chemistry, Manufacturing and Controls Quality Assurance (CMC QA). The GMP QA candidate will support quality compliance and quality audits at contract manufacturing organizations responsible for clinical product manufacturing and testing and/or commercial product manufacturing and testing by the (cGMP), commercial product supplies and/or clinical trial material supplies and product quality assessment. The successful candidate will provide support for chemistry, manufacturing and controls and authoring/review/approval for product development records, manufacturing batch records (MBR/EBR), Process Validation (PV/PPQ), analytical records, shipping records, release/disposition of batches, design controls, design validation, design history files (DHF), investigations of deviations, temperature excursions, out of specifications (OOS) during manufacturing and testing, product complaints, supply chain, standard operating procedures (SOP) of CMC Quality Assurance, regulatory submissions and support during pre-approval inspections (PAI) and GMP inspections at Contract Manufacturing Organization or Contract Manufacturing Development Organizations (CMOs or CDMOs). The ideal consultant candidate will be a Manager, Senior Manager or Associate Director, GMP Quality Assurance level from a prior Pharmaceutical or Biotech company with a 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 Manufacturing or late stage Clinical Manufacturing either in-house/1st party and/or at a CMO or CDMO/3rd party. Role and Responsibilities: Support, follow and maintain GMP quality assurance, quality management systems and policies, and SOP. Contribute to Quality Compliance of manufactured drug substance, raw materials and drug product, labeling, package inserts, and packaging of commercial products and clinical products, and commercial product distribution and clinical trial material distributions, 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, design verification, risk management, design history files 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 product 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 program including vendor qualification 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 10 to 15 + years of CMC/GMP Quality Assurance (GMP QA) related prior experience in commercial injectable product manufacturing, combination injectable product manufacturing or clinical injectable product manufacturing at a Pharmaceutical or Biotechnology Company. Prior experience in * Quality Management Systems, Quality Compliance, Quality Audits for commercial products and/or clinical pipelines is a must. * FDA pre-approval inspections and GMP inspections 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 or medical devices is a must * working with CMO, vendors, and 3PL-supply chain/distribution of late stage clinical products is a must * working with CDMO, vendors, and 3PL-supply chain/distribution of commercial products is a plus * review/authoring of CMC 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 and Iso guidance for drug substance, drug products, injectable drug products, combination products, and/or medical devices is required, as applicable.

Responsibilities

The consultant will support Chemistry, Manufacturing and Controls (CMC) related Quality Management System, Quality Assurance Compliance, Quality Audits, and oversight of external manufacturing and supply chain for clinical and commercial drug products. Key activities include supporting quality compliance and audits at contract manufacturing organizations and authoring/reviewing/approving various quality and manufacturing records.