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Senior Director | Manufacturing

Employer
Scilex Holding Company
Location
Palo Alto, CA
Start date
Nov 3, 2023

View more

Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Target salary range: $225,000 to $300,000

About Us: 

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 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 2023. 

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop, implement, and maintain GMP manufacturing, process validation-PV/process performance qualification-PPQ , continuous process verification (CPV), equipment validation, and product development for commercial and clinical drug products at external manufacturing sites.
  • Review CDMO/CMO manufacturing services agreements, support quality agreements, RFP
  • Oversee FMEA, PV/PPQ, CPV, and GMP manufacturing for commercial and clinical drug products
  • Manage formulation development and process development for commercial and clinical drug products
  • Manage supply chain for commercial and clinical drug products
  • Support analytical method development, validation and testing for drug substances and for commercial and clinical drug products
  • Support Manufacturing related CMC Department Budget and interactions with Finance Department for Budget Reviews
  • Ensure GMP compliance of manufactured drug substance, drug product, labeling, and packaging of commercial products and clinical products and raw materials

. Support other logistics for commercial products as required. 

  • Provide manufacturing oversight of Contract Manufacturing Development Organizations (CDMOs/CMOs), Contract Laboratories, 3rd Party Logistics (3PL) providers and other contracted vendors used for commercial and clinical products
  • Support supply chain and logistics including serialization of case, carton and pallet level for commercial as required

. Support supply chain and logistics for clinical products as required.

  • Support authoring/review/approval of development protocols/reports, PV/PPQ, MBRs and EBRs and final product disposition
  • Support and collaborate with Quality Assurance for investigation and resolution of product complains with external party
  • Review commercial and investigational product complaints
  • Support and collaborate with Quality Assurance, Quality Control, Supply Chain for supply chain and logistics and return product’s disposition/destruction at a 3PL

. Support and collaborate with Clinical Development, Medical Affairs, Sales and Marketing, Finance and Legal staff members  as required.

. Support  authoring/review/approve SOP and policies related to CMC.

. Support tracking, trending, and analyzing analytical release and stability data, manufacturing, and OOS/OOT, investigations, deviations, product complaints.

  • Review/author/approve CMC reports and associated regulatory filing documents, as required
  • Review/approve deviations, OOSs/OOTs, Change Controls, CAPAs and any other related Quality records
  • Review/approve product specifications, test methods, qualification/validation protocols and reports
  • Contribute to identifying compliance risks, perform risk management, and implement risk mitigation, as applicable.
  • Monitor, track, and trend stability data and GMP quality systems and establish metrics
  • Contribute to GMP audit activities for DS and DP, including vendor qualifications, establishing audit schedule, conducting audits, reviewing an audit report, and closing out audits
  • Support internal and external audit program including vendor qualification and routine or for cause audits and inspection readiness at CDMO/CMO, 3PL, and Vendors and regulatory pre-approval inspections (PAI) and GMP inspections as required
  • Support systems and procedures required for GMP compliance and FDA 21 CFR-Part 11
  • Support product quality documentation system by writing, reviewing, approving and updating quality assurance procedures
  • 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

 

Travel up to 30 to 40%, as required

YOUR REWARD:

The chance to grow your career in a dynamic, growing, and collaborative environment. Earn a

competitive salary while allowing you to focus your attention on innovative science.

A comprehensive benefits package including full medical (HMO, PPO, HSA, and FSA options), dental,

vision, life and disability insurance, company-matching 401(k), 10 paid holidays, flexible PTO, and stock

options.

If this sounds like the right career to fit your personality and interests, we’re looking forward to it.

to meet you. Principals only. Recruiters, please don't contact this job poster.

Scilex Holding Company is an Equal Opportunity Employer

 

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
Telephone
(650) 516-4310
Location
960 San Antonio Road
Palo Alto
California
94303
US

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