ABOUT US

Target Salary Range ($140,000-$180,000)

SCILEX Pharmaceutical Inc. responsibly develops and brings branded products to market using technologies to maximize quality of life. We are uncompromising in our focus to become the global pharmaceutical leader committed to social, environmental, economic, and ethical responsibility. Dedicated to using our internal partnerships, we deliver the next generation of products that are responsible by design. 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.

SCILEX Pharmaceutical Inc.. is a federal government contractor and, in compliance with its obligations under current federal regulations, SCILEX Pharmaceutical requires all employees, including newly hired employees, to present proof of vaccination against COVID-19, unless the employee is legally entitled to an accommodation. For further information, please refer to the Safer Federal Workforce Task Force’s September 24, 2021 Guidance for Federal Contractors and Subcontractors, available at: https://www.saferfederalworkforce.gov/contractors/.

WHAT WE ARE LOOKING FOR:

Scilex is dedicated to the development and commercialization of non-opioid pain management products. We are looking for enthusiastic and talented individuals who thrive on challenge and change, who can roll up their sleeves, put on multiple hats and have a can-do attitude without a lot of oversight or instruction.

We are seeking an Associate Director/Senior Manager of Supply Chain who is experienced, highly energetic, and committed to support supply chain management and logistics across all commercial and clinical products and project management requirements. The candidate reports to the Chief Technical Officer and is accountable for supporting/managing supply chain and logistics of commercial and clinical drug products and project management for Manufacturing, Testing and Quality Assurance aspects.

The individual will be responsible for inventory management and inventory tracking, supply planning, vendor management, logistics and cross-functional communication across Scilex’s commercial and clinical supply chain network and project management for Chemistry, Manufacturing and Control, and Quality Assurance Department. A strong knowledge of cGMP, supply chain and logistics/third party logistics/3PL and experience in working with contract manufacturing organizations (CMO), supply chain, shipments and distribution operations for commercial products as well as knowledge of cGMP and FDA, EMA, PMDA, HC guidelines as required. The ideal candidate will have a seasoned pharmaceutical or biotechnology company experience and a strong record of accomplishments in Commercial Supply Chain and Logistics using 3PL for global shipment and distribution.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage inventory and inventory management system like ERP or equivalent
• Track inventories and shipments of commercial and clinical products at 3PL
• Support commercial manufacturing shipment and inventory
• Support clinical labeling and packaging sites, as needed, and ensure clinical drug inventory is maintained in accordance with study plans
• Contribute to developing manufacturing plan across all CMOs and communication of forecasts to manufacturing partners
• May perform/contribute to Distribution Requirements Planning (DRP) to support both internal and external requirements for supply chain and distribution
• Lead efforts to define and update parameters needed for capacity planning
• Conduct project management for commercial and clinical manufacturing and quality assurance
• Support logistics operations of import/export of GMP and non-GMP materials including packaging.
• Help develop and participate in S&OP Process
• Work with the Quality team to establish temperature monitoring policy at the shipping conditions established for all GMP materials
• Create/contribute to policies and procedures to support commercial and clinical supply chain and logistics and scalable commercialization efforts
• Source and help with selection of new clinical and future commercial third-party logistics (3PL) vendors
• Reviews, and/or implements changes to controlled documents as needed. May author sections of regulatory documents
• Demonstrate an in-depth understanding of the financial aspects of Supply Chain
• May execute supplier agreements in conjunction with Manufacturing, Finance, Legal and other internal clients to ensure contracts, terms and conditions are in compliance with corporate and purchasing guidelines
• Identify and assist to resolve any risks to commercial and clinical supply chain
• Develop appropriate supply risk mitigation strategy via inventory planning.
• Apply for purchase orders for commercial and clinical product manufacturing and supply chain
• Contribute to Budgets and Finance and Costs of commercial and clinical manufacturing and supply chain and logistics and 3PL
• Oversee commercial and clinical product returns for supply chain
• Review Manufacturing Documents and Pharmacy Manuals
• Ensure adherence to applicable regulations including FDA, EMA, PMDA, HC, ANVISA, ICH, GMP, GCP and Scilex policies and procedures
• Establish excellent working relationships with contact manufacturing and service providers and internal teams within Scilex

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.
• Preferred Skills
• Minimum Master or bachelor’s degree in chemistry, biology, pharmaceutical sciences, pharmacy, engineering, or related field required.
• Minimum of 8 to 10 years of pharmaceutical or biotechnology industry experience in commercial supply chain and logistics for global distribution is a must
• Manage/contribute to outsourced distribution and shipping activities for commercial products with 3PLs, CMOs, and other external suppliers and contract manufacturing and service providers
• Experience in Commercial Supply required is a must, along with strong understanding of cGMP and cGCP regulations.
• Experience working with manufacturing cGMP
• Current or prior experience with ERP systems or equivalent for supply chain, inventory management and tracking is a must. Experience with MS Project and Excel is a plus.
• Experience in both domestic and international transportation and logistics highly desirable.
• Knowledge of import/export regulations, including shipment clearance, pro-forma invoice generation and global trade compliance.
• Knowledge of cGMP, ICH, FDA, EMA, PMDA, HC guidelines regarding temperature controlled shipping requirements including room temperature or cold chain shipment.
• Establish history of effective collaboration with external logistics providers.
• Excellent communication and interpersonal skills and expeditious problem resolution
• 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%, 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 meeting you.

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

Scilex Pharmaceuticals Inc. is an Equal Opportunity Employer

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)