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Associate Director / Director | Quality Assurance

Employer
Scilex Holding Company
Location
Palo Alto, CA
Start date
Feb 3, 2024

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Discipline
Quality, Quality Assurance, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Target Salary Range: $160,000 - $225,000 

The pay range for this position is expected to be between $160,000 - $225,000/annually; however, the base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills and experience.  The total compensation package for this position also includes medical benefits, 401(k) eligibility, vacation, sick time, and parental leave.  Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.   

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other payment or compensation program) at any time, including reasons related to individual performance, Company or individual department/team performance, and market factors.    

Scilex Holding Company’s pay range data is provided in accordance with local state pay transparency regulations.  Scilex Holding Company may post different minimum wage ranges for permanent residency petitions pursuant to US Department of Labor requirements.     

Scilex Holding Company is committed to equal employment opportunities, and a workplace that embraces diversity and inclusion for qualified individuals of all backgrounds.

About Scilex

SCILEX HOLDING COMPANY (Nasdaq: SCLX, “Scilex”), is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain.  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 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. ZTlido® possesses novel delivery and adhesion technology designed to address many of the limitations of current prescription lidocaine patches by providing significantly improved adhesion and continuous pain relief throughout the 12-hour administration period.  Click here for ZTLido’s Important Safety Information and US Prescribing Information. 

We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute treatment of migraine, with or without aura, in adults. We launched ELYXYBTM in the U.S. in April 2023 and are planning to commercialize GLOPERBA in 2024. 

Our three product candidates are (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM”), a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica and has received Fast Track Status from the FDA. Currently there is no FDA approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a Phase 2, next-generation, triple-strength formulation of ZTlido, for the treatment of low back pain (“LBP”) and has received Fast Track Status from the FDA; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.  If these product candidates are approved by the FDA, we believe each of them could become the treatment option for their respective indications in the United States. 

SCILEX is committed to harnessing the power of revolutionary delivery technologies designed to safely and effectively provide therapies to those who need them the most. Scilex Pharmaceuticals and Semnur Pharmaceuticals are wholly-owned subsidiaries of Scilex Holding Company.

If you’re a high-energy, compassionate, and collaborative individual with a strong desire to make a difference in patient’s lives, we encourage you to consider joining the Scilex Holding team! 

Role and Responsibilities:

  • Develop, implement, and maintain GMP quality management systems, policies, and SOP.
  • Ensure 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.
  • Provide Quality Assurance oversight of Contract Manufacturing Organization or Contract Manufacturing Development Organizations
  • (CDMOs or CMOs), Contract Laboratories, 3rd Party Logistics (3PL) providers/distributors/shippers and other vendors used for commercial or clinical product manufacturing or testing.
  • Support PAI and GMP inspections at CMO and/or CDMO.
  • Conduct drafting/review/approval of MBRs and EBRs, PVP, AVP, CPV and perform final product release/disposition, COA.
  • Oversee investigation and resolution of product complaints with external party. Ensure commercial or investigational product complaints are investigated to ensure compliance.
  • Manage supply chain, logistics and return product disposition/destruction with 3PL.
  • Perform quality assurance review and approval of investigation, deviations, OOSs/OOTs, Change Controls, CAPAs and
  • any other related quality records.
  • Draft/review/approve SOP and policies related to CMC.
  • Review and approve, audit agenda/reports,  product specifications, test methods, qualification/validation protocols and
  • Reports, stability protocols/reports.
  • Identify compliance risks, perform risk management, and implement risk mitigation, as applicable.
  • Monitor, track, and trend stability data and GMP quality systems and establish metrics.
  • Perform GMP audit activities for DS and DP, including conducting vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out audits.
  • Establish and maintains the internal and external audit program including vendor qualification and routine or for cause audits and inspection readiness at CDMO/CMO, 3PL, and Vendors.
  • Experience working with CDMO/CMOs, vendors, and 3PL-supply chain/distribution of clinical products is a plus.
  • Experience in Device Quality System, Design, Manufacturing and Testing, 21 CFR Part 820, DHF, DHR, DMR, and overall Device Regulations, CDRH and 510 k or PMA approvals are a plus.
  • Extensive knowledge of CMC/Module 3, Quality Management Systems, 21-CFR-Part 11, Part 210, Part 211, GMP regulations, ICH   Guidelines, FDA Regulations and Guidance are required.
  • Maintain systems and procedures required for FDA Field Alert Reporting and Recalls.
  • Create product quality documentation system by writing and updating quality assurance procedures.
  • Manage GMP training and provide quality training as appropriate Perform other duties as required.

Qualifications and Education Requirements

  • Minimum bachelor’s degree in chemical engineering, science, chemsitry or in a relevant scientific discipline or equivalent
  • Minimum of 10 to 15 + years of GMP Manufacturing Experience 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 GMP manufacturing for commercial products and/or late stage/Phase 3 clinical pipeline is a must
  • Experience in formulation development and PV/PPQ for commercial products and clinical pipeline is a must
  • Experience managing manufacturing budget is a must
  • Experience in reviewing/authoring/approving of CMC protocols/reports, pharmacy manuals, and associated regulatory filing documents is a must
  • Experience in FDA pre-approval inspections and GMP inspections is a plus
  • Experience in Department Budget Maintenance and Review is a plus
  • Experience in Aseptic Product Manufacturing, Transdermal Patch Manufacturing or Solid Dosage Product Manufacturing for commercial products or late-stage clinical products is a must
  • Experience in interacting with active pharmaceutical ingredients (API), raw materials and packaging components is a must.
  • Experience working with CDMO/CMOs, vendors, and 3PL-supply chain/distribution of commercial products is a must
  • Experience working with CDMO/CMOs, vendors, and 3PL-supply chain/distribution of clinical products is a plus
  • Experience in Device Quality System, Design, Manufacturing and Testing, 21 CFR Part 820, DHF, DHR, DMR, and overall Device Regulations, CDRH and 510 k or PMA approvals are a plus.
  • Knowledge of Quality Management Systems, 21-CFR-Part 11, Part 201, Part 2011, GMP regulations, ICH Guidelines, FDA regulations and Guidance is required
  • Proven ability to achieve results and success in a group environment and on cross-functional teams is required
  • Support and ensure Quality Compliance for Manufacturing at CDMOs/CMOs, 3PL and vendors in a virtual environment
  • Strong communication and interpersonal skills are required
  • Ability to multi-task, shift priorities, and work in a fast-paced collaborative environment
  • Detail oriented and well organized
  • Team player, professional demeanor, enthusiastic, and self-motivated

Preferred Skills 

  •  Ability to work independently and as a team member.
  •  Basic knowledge of pharmaceutical industry.
  •  Goal and results driven.
  •  Strong process facilitation, problem solving and analytical thinking abilities to make sound business decisions on a day-to-day basis.
  •  Excellent verbal, written and interpersonal communication skills.
  •  Clear, articulate and grammatically sound speech and professional manner.
  •  Strong focus on providing customers with superior support and service.
  •  Ability to learn, understand and communicate complex information.
  •  Strong rapport building skills and active listening skills.
  •  Excellent selling, closing, persuasion and presentation skills.

Company

SCILEX HOLDING COMPANY (Nasdaq: SCLX, “Scilex”), majority-owned by Sorrento, 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 ZTlido® (lidocaine topical system) 1.8%, is a branded 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.

Scilex’s SP-102 (10 mg dexamethasone sodium phosphate viscous gel injection), or SEMDEXA™, for the treatment of Lumbar Radicular Pain has completed enrollment in a Phase III clinical trial and has received Fast Track Status from the FDA. If approved by the FDA, the company expects SP-102 to be the first FDA-approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica, with the potential to replace 10 to 11 million off-label epidural steroid injections administered each year in the US.

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

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

Company info
Website
Phone
(650) 516-4310
Location
960 San Antonio Road
Palo Alto
California
94303
US

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