Quality Control Consultant at Scilex Holding Company

Salary Range: $150,000.00 - $225,000.00

The pay range for this position is expected to be between $150,000 - $225,000/annually. 

Job Type:  Dedicated Consultant – 40 hours per week

About Scilex

SCILEX Holding Company is dedicated to the development and commercialization of non-opioid pain management products. We are uncompromising in our focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. The Company’s lead product under development, ZTlido™ lidocaine patch 1.8%), is a branded lidocaine patch formulation for the potential treatment of relieving the pain of postherpetic neuralgia, also referred to as after-shingles pain.

The company’s lead product ZTlido^® (lidocaine topical system) 1.8%, is a marketed prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain. Click here for ZTLido’s Important Safety Information and US Prescribing Information.

Scilex’s SP-102 (10 mg dexamethasone sodium phosphate viscous gel injection) for the treatment of Lumbar Radicular Pain has completed a Phase III clinical trial and has received Fast Track Status from the FDA. The safety and efficacy of SP-102 has not been confirmed by any regulatory agency. Currently there is no FDA approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica. 

SCILEX is committed to harnessing the power of revolutionary delivery technologies designed to provide therapies safely and effectively to those who need them the most.

Scilex Pharmaceuticals and Semnur Pharmaceuticals are wholly-owned subsidiaries of Scilex Holding Company.

Summary of Quality Control Consultant Position:

The candidate reports to the Chief Technical Officer and will support analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule products and ensure commercial product manufacturing operations and clinical candidates from development to commercialization.  The successful candidate will provide technical leadership and contribute/manage quality control activities including review/approval of data tables and documentation from Contract Manufacturing Organizations/Contract Manufacturing Development Organizations (CMO/CDMO), or Raw Material and Packaging components, Manufacturers/Suppliers, quality audit reports and regulatory submission documents and review/assessment of new CMO/CDMO. The ideal consultant will be a prior employee from a pharmaceutical company or

biotechnology company with a strong record of accomplishments in analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule or biological products.

Role and Responsibilities:

• Support analytical development and quality control/analytical testing of commercial or late-stage clinical small molecule products, drug substance, raw materials, packaging components, manufacturing equipment qualifications at existing CDMO/CMO or method a new CDMO/CMO.
• Review/support CDMO/CMO manufacturing services agreements, support quality agreements, RFP from analytical testing perspectives.
• Support testing for analytical method development and method validation/MV for commercial and clinical products at CMO/CDMO.
• Support testing for FMEA, process performance qualification/PPQ, continuous process verification/CPV, equipment qualification, site registration, cleaning studies/validation, shipping studies/validation, etc. for commercial and clinical products at CMO/CDMO.
• Support testing for formulation development, process development, forced degradation, extractable and leachable studies for commercial and clinical products as required.
• Author/review/approve from analytical testing perspectives of analytical method development, method validation protocols/reports, PV/PPQ, CPV, MBRs and EBRs and final product disposition, any CMC development protocols/reports, qualification/validation protocols/reports, stability protocols/data/reports, and release/stability specifications.
• Support analytical method development, method validation and testing for drug substances present in commercial and clinical products at CMO/CDMO.
• Support testing for drug-drug interactions, combination products or human factor studies as required
• Ensure GMP compliance from analytical testing perspectives for raw materials and packaging components required for manufacturing of drug substances and commercial and clinical products.
• Provide analytical testing assessment for Contract Laboratories, 3rd Party Logistics (3PL) providers and other contracted vendors used for commercial and clinical product manufacturing at CMO/CDMO as required.
• Support logistics for commercial and clinical products as required
• Support authoring/review/approval from analytical testing perspectives PV/PPQ, CPV, MBRs and EBRs and final product disposition
• Collaborate with Quality Assurance for quality audits, investigations of OOS, deviations, change controls, CAPA, and temperature excursions as required.
• Support tracking, trending, and analyzing from analytical perspectives release and stability data, manufacturing records, batch failures, OOS/OOT, investigations, deviations, change controls, CAPA, product complaints as required.
• Support Quality Assurance for product complaints as required.
• Support Product Development, Manufacturing, Quality Assurance, Supply Chain within CMC group.
• Review/author/approve CMC related regulatory submissions, as required
• Review/approve deviations, OOSs/OOTs, Change Controls, CAPAs and any other related Quality records.
• Support authoring/review/approve SOP and policies related to CMC as required.

Qualifications and Education Requirements

• Perform other duties as required
• Support from analytical perspectives internal and external audits and regulatory pre-approval inspections (PAI) and GMP inspections as required
• Support from analytical perspectives GMP audit activities and reviewing audit reports and closing out audits as required. 
• Collaborate with Clinical Development, Medical Affairs, Sales and Marketing, Finance and Legal groups as required.
• Minimum bachelor’s degree in analytical chemistry, biochemistry, biology, chemical sciences or in a relevant scientific discipline or equivalent
• Minimum of 8 to 12 + years of analytical development and quality control for Commercial Products or Late-Stage, Phase 3 Clinical Product in Pharmaceutical or Biologic Companies.
• 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.
• Experience in Quality Control/Analytical Testing for GMP manufacturing of commercial products and/or late stage/Phase 3 clinical pipeline is a must
• Experience in analytical method development, method qualification/method validation, release and stability testing, investigations, deviations, change controls, CAPA and OOS/OOT for commercial products and clinical pipeline is a must
• Contribute to identifying compliance risks, perform risk management, and implement risk mitigation, as applicable.