Keysource Pharmaceuticals Jobs in Usa

Company Overview:

Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.

Overview:

We’re hiring an Associate Process Control / Automation Engineer to join a pharmaceutical manufacturing team. This full-time role is ideal for early-career engineers with 2+ years of experience in process automation, hands-on DeltaV Batch DCS work, and exposure to regulated manufacturing environments.

Key Responsibilities:

• Act as automation engineer for assigned unit operations, including DeltaV Batch DCS configuration and control module development
• Translate process engineering narratives into functional requirements and control logic
• Develop graphics in reference with process P&IDs and maintain communication with other process cell owners for alignment
• Interface with customer Process Engineering team and outsourced vendors
• Establish requirements for configuration, testing, and release in alignment with project schedule
• Review and provide oversight of vendor-provided software development
• Support Computer System Validation (CSV) documentation for assigned process cells
• Execute software application testing, including FAT/SAT activities

Qualifications:

• Bachelor’s degree in Chemical, Electrical, or Controls Engineering
• 2+ years of hands-on experience in process automation or process control in pharmaceutical or regulated manufacturing
• Experience with DeltaV Batch DCS required; familiarity with other DCS/PLC platforms (Honeywell, Rockwell PlantPAx) is a plus
• Knowledge of ISA-88 batch standards, GMP, and CSV principles
• Strong collaboration, communication, and documentation skills

About Our Culture:

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Learn more about us:

Visit our website at to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences

Our client – a global and growing BioPharma CDMO company needs an Engineering Line Lead with Pharmaceutical Industry experienceat their expanding plant in WA state, Excellent total comp. up to $180K+ with excellent Benefits + Relocation Bonus. Client will sponsor for H1B Visa transfer.

Job Posting # 2705R

Job Title: Engineering Team Lead Overnight Travel: 10%

Location: Spokane, WA

Relocation: YES – Theclient offers a lumpsum bonus for relo assistance.

Compensation:Salary range $120K - $165K+ Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will have 3 people reporting under this person and handle all technical aspects for this new line 3 (note 1 + 2 below)

This role will report to the Engineering Manager.

Note 1: The company recently completed installation of their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are expanding again with a 4th line at this growing plant site.

Note 2: The primary focus will be the technical and project engineering aspects of a complete filling line.

Note 3: Client willsupport transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Summary:

The Engineering Line Lead position provides leadership, manufacturing support and coordination of the engineering department for the CMO line specific projects.

This position ensures that contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company management initiatives, compliance guidelines, the project management system, and the capital budget schedule.

It is the responsibility of this position to ensure line specific compliance of the CMO equipment and team with state, local, and federal regulations.

This position ensures operations and projects are carried out under adherence to GEPs and cGMPs.

Job Functions and applications in cGMP settings.

1. Provide technical oversight and leadership to the engineering team roles responsible for their area of responsibility within the CMO Business Unit.
2. Drive technical improvements and internal/external responses to equipment and facility observations.
3. Management of the assigned capital project schedules and budgets.
4. Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
5. Coordinate and supervise engineering resources to ensure adequate and appropriate staffing for current and upcoming projects.
6. Ensure designated area, equipment and engineering infrastructures are compliant to local, state, federal, and international regulatory agencies.
7. Execute high level projects from conception, consistent with upper management objectives for business growth.
8. Manage and execute facility and equipment updates to meet company growth and economic objectives.
9. Support client audits and technical visits.
10. Effectively communicate project status, constraints and current or potential issues to upper management.

Candidate Must Have:

• Bachelors of Science in Engineering or related technical degree.
• 5+ years of Engineering Experience
• 3+ years of Engineering experience in the BioPharma industry
• 2+ years of Project Engineering/Management experience
• Some Leadership, Supervisory experience over Jr. Engineers, Technicians.
• Facility or Manufacturing Engineering Experience
• MS Office suite (Word, PowerPoint, Excel) experience

Candidate Nice to Have:

• BS in Mechanical, Chemical, Electrical, Manufacturing engineering
• Advanced degree or PE or PMP certification
• Experience with PM Software – MS Project, Design software - AutoCAD & ERP – SAP
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Interfacing with OEM equipment vendors, Construction/consulting partners

Keywords: Projects, Plant Project, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Supervisor, Lead

Job Description: Compounding Pharmacist

Location: Houston, TX

Experience Level: 0–3 years

Employment Type: Full-time

About Us

We are a relatively new pharmaceutical startup based in Houston, Texas, focused on delivering high-quality compounded medications and personalized patient care. As a growing company, we offer exciting career development and advancement opportunities for driven professionals who want to make a meaningful impact from the ground up.

Responsibilities

• Prepare customized medications in accordance with prescriptions and compounding standards
• Ensure accuracy and compliance with all regulatory guidelines and safety protocols
• Communicate effectively with patients, healthcare providers, and team members
• Maintain meticulous records of formulations, ingredients, and inventory
• Collaborate with pharmacy technicians and support staff to ensure timely service
• Stay current with pharmaceutical trends and compounding techniques

Requirements

• Doctor of Pharmacy (PharmD) degree from an accredited institution
• Active pharmacist license in the state of Texas (or eligibility to obtain)
• 0–3 years of professional pharmacy experience
• Strong attention to detail and organizational skills
• Excellent verbal and written communication abilities
• Demonstrated responsibility, focus, and a hardworking attitude
• Compounding experience is a plus, but not mandatory

What We Offer

• Supportive team environment with mentorship opportunities
• Hands-on training in compounding practices
• Competitive salary and benefits package
• Career growth potential in a fast-growing startup pharmacy

JOB DESCRIPTION

Insight Global is seeking a highly skilled Rebate and Returns Analyst to assist commercial rebates, administrative fees, billbacks and other after sales expenses; ensure prompt payment to Wholesalers, Retailers, Distributors and Group Purchasing Organizations for one of our pharmaceutical organizations in the Elmwood Park, NJ area. This candidate will be preparing executive summary level reporting to the customer, field force and Contracts and Pricing management. This role requires close interaction with Credit and Collections, handling payment reconciliations as well as variance analysis against customer claims. Backfilling contract management as needed and working closely with A/R, A/P and GTN Team. Building and maintaining all customer incentive programs in revenue management system.

***Pharmaceutical experience is NOT required.

REQUIRED SKILLS AND EXPERIENCE

•Strong experience with Excel

•Comfortable going onsite 3 times per week in office in Elmwood Park, NJ

Head of Analytical Development

Location: On-site near Union City, CA

Industry: Biopharmaceuticals / Biologics

A pioneering biopharmaceutical innovator in the Bay Area is expanding its R&D leadership and seeking a Head of Analytical Development. This role is vital to advancing the company’s innovative therapies pipeline, particularly within biologics, through scientific excellence, method innovation, and regulatory strategy. The company is preparing for pivotal product milestones and regulatory interactions, offering a high-impact role for a scientific leader ready to shape analytical development strategy and lead a cross-functional team.

Key Responsibilities:

• Provide strategic, scientific, and operational leadership across the analytical development function supporting biologics programs from early phase through commercialization.
• Lead development, optimization, validation, and transfer of analytical methods for drug substances, drug products, and non-compendial raw materials.
• Design and direct complex extended characterization studies to support regulatory filings and technical documentation.
• Collaborate cross-functionally with internal teams (Process Development, MSAT, Quality, Regulatory) and external partners (CROs, CDMOs, CTLs) to ensure analytical alignment across development stages.
• Guide laboratory operations and provide scientific mentorship to a team of scientists and technical leaders.
• Oversee stability studies of critical reagents and engineering/non-GMP batches to support formulation and manufacturing decisions.
• Act as the analytical SME in cross-functional teams and represent analytical function in CMC development and regulatory discussions.

Required Background:

• B.S. in biological sciences or related discipline with 8+ years (or M.S. with 6+ years) of progressive analytical development experience in the biotech or pharmaceutical industry.
• Proven experience leading scientific teams and mentoring scientists in an analytical development setting.
• Expertise in a broad range of analytical techniques such as SDS-PAGE, chromatography (HPLC/UPLC), CE-SDS, icIEF, ELISA, western blotting, and cell-based potency assays.
• Hands-on experience with advanced characterization techniques such as AUC, LC/MS, DLS, NMR, and circular dichroism.
• Demonstrated success in method development, validation, tech transfer, and authoring CMC documentation for regulatory submissions.
• Familiarity with DoE approaches and statistical tools like JMP, R, or Python.
• GxP experience and strong understanding of quality and regulatory standards.

Preferred Qualifications:

• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, or related discipline.
• Experience in extended characterization (e.g., SEC-MALS, peptide mapping, disulfide mapping, PTM analysis).
• Background in neurotoxin or biologics development is a strong plus.
• Experience overseeing CRO/CDMO relationships and managing analytical-related quality documentation such as deviations, change controls, and investigations.

Why Join Us:

• Be at the forefront of biologic drug development in a high-growth company committed to improving patient outcomes.
• Influence CMC strategy and product development in a collaborative, science-first environment.
• Join a mission-driven culture that values innovation, scientific rigor, and operational excellence.
• Competitive compensation, bonus eligibility, comprehensive healthcare, flexible PTO, and professional development support.

About Blue Signal:

Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at /46Gs4yS

Visual Inspection Associate

Duration: 6 month contract, potential for extension or conversion

Location: Pleasant Prairie, WI

Shift: 3rd shift 10PM-630AM

Position Overview:

The Operator – Visual Inspection will work at our client's Manufacturing site in Kenosha County WI, where parenteral products for domestic and international markets are manufactured and packaged. The primary purpose of this role is to safely inspect high-quality pharmaceutical products in accordance with site standards and current Good Manufacturing Practices (cGMP) within controlled facilities.

This position requires operation of various automated and semi-automated manufacturing equipment, as well as performance of manual inspections. The operator is responsible for ensuring product quality while demonstrating a strong commitment to safety, compliance, and operational excellence.

Responsibilities:

• Adhere to Parenteral Manufacturing safety policies and procedures and contribute to a safe work environment.

• Set up and operate non-aseptic manufacturing processes, including automated and semi-automated inspection equipment in controlled facilities.

• Follow standard operating procedures (SOPs), cGMP requirements, and safety policies and procedures.

• Accurately document process steps using appropriate batch documentation systems (paper and electronic).

• Participate in department meetings, team-building activities, and training programs.

• Provide input into department SOPs and training materials as needed.

• Maintain accountability for working safely and supporting all site and corporate health and safety goals.

Basic Requirements:

• Minimum education: High School Diploma or GED

• Must pass a post-offer physical examination

• Must pass an eye exam and not be color blind

• Ability to wear required safety equipment (safety glasses, safety shoes, protective gloves, etc.)

• Ability to work within a shift-based schedule

• Willingness to work overtime, weekends, and off-shifts as required

Additional Skills / Preferences:

• Experience working in a GMP-regulated environment

• Ability to troubleshoot basic production issues and effectively use tools

• Experience with PMX, MasterControl, Flow-stream, or other electronic batch documentation systems

• Previous pharmaceutical manufacturing experience

• Experience with manual, automated, and semi-automated inspection processes

• Strong attention to detail when performing manufacturing tasks and documenting production activities on paper and computer-based systems

• Basic math skills, including evaluation and interpretation of production data

• Basic computer skills, including use of HMIs and other computer terminals to monitor equipment status and document production activities

• Excellent documentation skills

• Proven teamwork skills and ability to work closely with operations teams during line setup, operation, and changeovers

Additional Information:

• Ability to work overtime as required

• Ability to wear required safety equipment (glasses, shoes, gloves, etc.)

• Primary work location: Kenosha County, Wisconsin

• Ability to travel up to approximately 10%

This job description is intended to provide a general overview of the job requirements at the time it was prepared. Job responsibilities may change over time and may include additional duties not specifically described. For GMP purposes, the job description should be updated for significant changes. Employees should consult their supervisor regarding actual job responsibilities and related duties.

About the Company

Job Title: IT Infrastructure Support Specialist – IT Services (Pharmaceutical Manufacturing) Location: Lebanon, Indiana, US ---(Onsite)

Required Experience & Qualifications:

• Solid understanding of enterprise networking concepts including LAN/WAN, TCP/IP, VLANs, routing protocols (BGP, OSPF), network security principles, and SD-WAN technologies
• Deep understanding of enterprise-grade network equipment and how they are deployed and supported, including Cisco/Juniper routers, switches, firewalls, and wireless infrastructure
• Strong Network monitoring and troubleshooting experience using tools such as SolarWinds, PRTG, or Wireshark
• Proficiency in deploying and troubleshooting Windows OS (Windows 10/11, Server 2019/2022), end-user devices, and enterprise imaging tools such as SCCM or Intune
• Experience automating repetitive processes using tools or scripting (PowerShell, batch script, python, etc)
• Experience installing and supporting networked printers, scanners, MFDs, and manufacturing floor devices such as barcode scanners and label printers
• Familiarity with Active Directory, Group Policy, virtualization platforms (VMware/Hyper-V), and ITIL-based ticketing systems such as ServiceNow
• Experience providing technical support in a GxP or FDA-regulated pharmaceutical manufacturing environment
• Working knowledge of computer system validation (CSV), change control processes, and GxP documentation requirements
• Ability to work independently while leveraging existing processes and developing new ones to support a site start-up environment
• Strong interpersonal and communication skills with the ability to build effective relationships with cross-functional business partners
• Bachelor's Degree in Computer Science, Information Technology, or a related technical field; certifications such as CCNA, CompTIA Network+, or CompTIA A+ preferred

Position Summary

The Vice President (VP) of Sales and Marketing is a strategic executive leadership role reporting directly to the CEO and serving on the Executive Leadership Team. This position leads and aligns MedPharm’s Business Development, Project Management, and Marketing functions with the shared goal of accelerating sustainable revenue growth. The VP of Sales and Marketing is responsible for setting and executing the company’s commercial strategy, cultivating client relationships, driving top-line performance, and leading a high-performing cross-functional team that represents MedPharm in the market. This leader will ensure consistent delivery of integrated solutions across all stages of the client lifecycle—from lead identification to contract signing and program execution—within the context of MedPharm’s CDMO business focused on topical and transdermal drug development and manufacturing.

Essential Functions

Strategic Leadership & Growth

• Own and execute the commercial strategy to grow MedPharm’s development and manufacturing services globally.
• Lead the Business Development and Project Management functions to ensure alignment across pre-sales, proposal generation, contracting, and program delivery.
• Serve as a primary driver of growth strategy, pipeline development, forecasting, and sales target achievement.
• Partner with the CEO and Executive Team to provide insight and updates to the Board of Directors on growth initiatives, pipeline strength, and go-to-market performance.

Team Management & Performance

• Recruit, develop, and retain high-performing Business Development and Project Management teams.
• Coach team members to continuously improve client engagement, customer service, proposal requests, technical positioning, and deal closure capabilities.
• Establish KPIs and reporting tools to monitor team effectiveness, sales pipeline health, and client satisfaction.
• Cultivate a collaborative and accountable culture that fosters internal alignment and a unified client experience.

Commercial Execution

• Lead pricing discussions in coordination with Finance and Technical teams to ensure profitable, competitive proposals.
• Lead contracting and negotiation in collaboration with legal and operational leadership.

Market Positioning & Intelligence

• Direct marketing efforts to strengthen the MedPharm brand, elevate market visibility, and clearly communicate service differentiation.
• Analyze market trends, client feedback, and competitor activity to inform strategic planning and identify emerging opportunities.
• Contribute to cross-functional development of new service offerings and solutions based on market needs and internal capabilities.

Operational & Financial Oversight

• · Collaborate with functional peers across Technical, Manufacturing, Quality, and Finance to ensure effective internal handoffs and delivery of contracted programs.
• Develop and manage department budgets; ensure optimal allocation of resources to achieve strategic goals.
• Utilize CRM and business intelligence tools to drive data-based decision-making and process automation.

Supervisory responsibilities:

· Direct Reports: Yes

· Indirect Reports: Yes

Travel requirements:

· Yes, 50%

Education and Experience

• At least 10 years of experience in the pharmaceutical industry with at least 5 years’ experience as Business Development Director or equivalent Bachelor’s of Science Degree required, MBA preferred.
• Combined CRO and cGMP experience preferred. Demonstrated customer focus – a track record of building and maintaining positive customer relationships and key business outcomes

Required Qualifications

• Proven experience growing business through leadership of commercial functions, including Business Development, Project Management, and Marketing.
• Demonstrated success leading and developing cross-functional sales teams in pharmaceutical or life sciences sectors.
• Experience managing global client relationships across North America, Europe, and ideally Asia.
• Deep knowledge of topical and transdermal dosage forms; small molecule drug development experience preferred.
• Track record of individual sales success and effective transition into strategic sales leadership.
• Expertise in developing, scaling, and optimizing commercial business processes and tools.

Knowledge, Skills, and Abilities

• Strategic Vision: Ability to drive long-term growth strategies while managing near-term priorities.
• Team Leadership: Inspires high performance, accountability, and collaboration across functions.
• Client Focus: Builds strong partnerships through trust, value creation, and responsive service.
• Commercial Acumen: Skilled in opportunity evaluation, pricing strategy, and contract negotiation.
• Communication: Exceptional ability to articulate complex concepts across audiences and formats.
• Executional Agility: Balances big-picture thinking with hands-on engagement where needed.

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

• Requires frequent standing, walking, & gripping
• Requires constant sitting, seeing, & hearing
• Requires occasional carrying, lifting, pushing, & pulling under 20 LBS

Immediate need for a talented Specialist 4 - Medical Writing/Medical Writer, Medical Information, Payer and Health Systems. This is a 06 Months Contract opportunity with long-term potential and is located in Titusville, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-06073

Pay Range: $50 - $69/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Payer Scientific Content and Materials – 70%
• Supports the development and timely dissemination of tailored, evidence-based scientific materials for assigned therapeutic area products.
• Member of the multi-disciplinary team tasked with reviewing and approving of Payer regulated content prior to it being used
• Supports the development of AMCP standard and pre-approval dossiers, Medicaid formulary requests, and custom requests working collaboratively with Medical Affairs and Real-World Value & Evidence (RW V&E) therapeutic area leads.
• Engages in shaping and development of the Payer Digital Assets in collaboration with Med Info CSI/
• Digital partners.
• Works closely with RW V&E Field, Medical Affairs Therapeutic Area team(s) and Medical Information Scientific Engagement Contact Center to guide creation and delivery of responses to unsolicited Medical Information Requests from Payers and Health Systems
• Supports the development and dissemination of scientific information in support of assigned products to Clinical Decision Resource Organizations (CDRO) in partnership with Medical Information Affairs, RW V&E, SCG, Therapeutic Teams
• Support interactions with drug compendia and collaborates with AD, Med Info PHS and business partners to evaluate strategies for compendia interactions.
• Ensures optimized delivery of high-quality and efficient Payer scientific content and materials by vendors, provides real-time feedback and first line scientific review of materials as needed. Voice of Customer and Metrics – 20%
• Leverage voice of customer and other sources of customer information and identify actionable items to enhance the development of Payer and Health Systems materials.
• Projects and Research – 10%
• Participates in ad-hoc projects and activities as assigned by management.
• Conducts benchmark and research on the landscape of Payer, Healthcare Intermediaries, and health systems

Key Requirements and Technology Experience:

• Key skills: Payer Scientific Content and Materials
• Voice of Customer and Metrics
• Works closely with RW V&E Field, Medical Affairs Therapeutic Area team(s) and Medical Information Scientific Engagement Contact Center
• Excellence in leadership skills, collaboration in a matrix environment, influencing, ability to work both individually and as a team contributor
• Excellence in communication (both written and presentation), pharmaceutical industry experience
• Expertise in the healthcare industry, clinical knowledge, or practice across multiple therapeutic areas

Our client is a leading Pharmaceutical industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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Job Title: Field Reimbursement Manager (FRM) – Remote with Territory Travel

Location: Remote – depends on candidate's location

Travel: Up to 80% (4 days/week) via automobile or air

Position Overview

We are seeking a Field Reimbursement Manager (FRM) to support access and reimbursement services for a specialty pharmaceutical product. In this client-facing, remote-based role, you will work directly with physician offices and manufacturer partners to resolve reimbursement challenges and deliver critical education on payer landscapes and available support services. The FRM acts as a trusted advisor and key liaison between healthcare providers, specialty pharmacies, and internal patient support services. This is a high-visibility, fast-paced role that demands a strong understanding of medical reimbursement, Medicare and commercial payers, and buy-and-bill or specialty pharmacy distribution models.

Key Responsibilities

• Field & Virtual Education (35%) - Deliver on-site or virtual training and education to healthcare providers and staff on reimbursement processes, including lunch-and-learns and scheduled presentations. Log all activity in CRM daily.
• Benefit & Access Education (25%) - Educate providers on benefit verification, prior authorization, payer trends, and support center services. Document and report all interactions as required by the client.
• Reimbursement Support (20%) - Assist offices with claims, billing and coding, appeals, medical benefit interpretation, and co-pay or patient assistance programs. Coordinate closely with case managers for resolution.
• Territory Management (10%) - Manage a schedule of outbound calls, appointment setting, and in-office follow-ups. Collaborate with manufacturer field teams to ensure seamless communication and data sharing.
• Program Performance Monitoring (10%) - Track territory metrics in CRM, analyze trends, and contribute to quarterly reporting and customer satisfaction feedback as needed.

Qualifications:

• Bachelor’s degree or equivalent experience
• 8+ years in healthcare reimbursement (Buy & Bill, Specialty Pharmacy)
• Knowledge of Medicare & commercial insurance
• Strong communication, customer service, and organizational skills
• Proficient with PowerPoint, CRM systems, and virtual meeting tools
• Valid driver’s license; must be able to travel up to 80%

Preferred Qualifications:

• Field reimbursement or specialty pharmacy experience
• Account management or pharmaceutical industry experience

Working Conditions:

• Remote/Work-from-Home (must reside within the assigned territory)
• Travel required up to 80% (valid driver’s license and clean MVR required)

Benefit offerings available for our associates include:

• Medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan
• Flexibility to choose the type of coverage that meets individual needs
• Eligibility for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable

Equal Opportunity Employer/Veterans/Disabled

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