Careers

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Title: Senior Clinical Scientist – Full Time
Location: Inovio Pharmaceuticals, Inc.
Pennsylvania Office - 1787 Sentry Parkway Blue Bell, PA USA 19422

Qualifications & Requirements:
• Required education: Bachelor/Masters degree
• Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred.
• Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
• At least 7 years of clinical research experience. Regulatory affairs experience a plus.
• Thorough knowledge of all applicable regulations, including FDA, ICH and ISO guidelines. Medical device experience a plus.

Responsibilities:
To be responsible for overall clinical study conduct to fully ensure patient safety, verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Duties may include oversight of clinical trial operations as performed by a CRO or other external consultants.

Develops and manages clinical protocols and amendments, informed consent forms, training material, case report forms, diary cards, clinical study reports and other clinical documents, and contributes to the development of investigator's brochures. Ensures compliance with regulatory guidelines in the development of documentation.

Oversees study conduct and communicates study-related information to investigators and study staff. Oversees and tracks recruitment and retention of study subjects.

Manages study timelines. Reports on study progress and provides options for handling problems that develop. Provides progress updates and summaries to management. Develop tools and processes that increase efficiencies of the project.

Prepares regulatory documents for FDA and other regulatory submissions. Supports management with implementation of departmental strategies and policies.

Travel: Up to 20%, primarily domestic

Submit cv and salary requirements to: careers@inovio.com

Title: Assistant Clinical Scientist – Full Time
Location: Pennsylvania Office
1787 Sentry Parkway Blue Bell, PA USA 19422 

Qualifications & Requirements:
• Required education: Bachelor/Masters degree
• Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred.
• Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
• Years of experience required: 0-3 years of monitoring and/or 0-3 years of clinical trial management experience.
• Working knowledge of FDA regulations/guidelines, ICH guidelines, and GCPs • Demonstrates an understanding of trial and protocol objectives
• Demonstrates the ability to acquire a working knowledge of applicable medical indications

Responsibilities:
To assist in clinical site management including monitoring to fully ensure patient safety, verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs. Duties may include oversight of clinical trial operations as performed by a CRO or other external consultants. Helps to ensure that the quality of work and data are suitable to support Investigational New Drug applications (INDs).

• Assist in conducting all applicable site visits including: Pre-Study, Initiation, Interim, and Close-out.
• Support project initiation and project implementation.
• Assists with writing and development of informed consents, protocols, and amendments.
• Assists with planning and tracking of projects.
• Reviews and tracks regulatory documents at study start-up and during the trial Assists with review and design of Case Report Forms.
• Completes routine site follow-up reports and appropriate confirmation and follow-up letters.
• Assists with contract development, tracking, and negotiation for sites.

Travel: Up to 20%, primarily domestic

Submit cv and salary requirements to: careers@inovio.com

Title: Principal Electrical Engineer – Full Time
Location: San Diego Office
11494 Sorrento Valley Road, San Diego, CA, USA 92121

Qualifications & Requirements:
• Required education: Bachelor/Masters degree
• Minimum 15 years experience in electrical engineering
• Experience with all phases of developing embedded hardware systems in medical device instruments.
• Proficient with software life cycle and IEC62304.
• Determine and specify proper device labeling per world-wide requirements.
• Program Management with a Stage Gate Process.
• Experience with major applicable standards and regulations for design control, safety: FDA, ISO, CE, UL, IEC
• Evaluation and preparation of Intellectual Property.
• Skilled with analog and digital circuits, IC and PCB design and analysis experience.
• Failure analysis, bench top testing, evaluation and debugging of circuits.
• Experience managing contract manufacturers and software development.
• Experience with developing products from concept through validation and manufacturing.
• Generation of product development documentation: plans, specifications, procedures (test, manufacturing and QC), reports, design reviews and validation.
• Familiarity with Change Control, MRB, CAR, Complaints and Investigations.
• Design of PC based test and production stations.
• Familiarity with CAD design tools, e.g. Altium.
• Touch screen GUI interfaces.
• Servo motor control and feedback.
• Wave form and signal generation.
• Excellent teamwork, written and verbal communication skills required.
• Proficient with standard Microsoft Office tools: Word, Excel and PowerPoint.

Beneficial Skills:
• Programming skills: assembly, C.
• Knowledge of IC board inspection methods.

Responsibilities:
• Interact closely with Production, R&D, Legal and Marketing to support existing and new products.
• Interact with contract manufacturers, vendor consultants, sales and service organizations.
• Support product improvement/modification efforts of current medical devices based on field-experience and user-feedback.  Understanding of circuits and ability to debug circuits is critical.
• Lead instrument research, development and manufacturing efforts for next generation clinical and commercial devices.
• Design electronics for medical instruments.
• Select and work with outside development firms to meet program goals and timelines
• Verify, validate and document product designs.
• Follow processes for developing and supporting products.
• Complete other engineering duties as assigned.

Physical Requirements:
• Capable of typical office activities and lab bench top technical tasks commensurate with working with electrical/electronic circuits.

Submit cv and salary requirements to: careers@inovio.com

Title: Quality Manager, Engineering Operations – Full Time
Location: San Diego Office
11494 Sorrento Valley Road, San Diego, CA, USA 92121

Qualifications & Requirements:
• B.A. or B.S. in health sciences or other technical field, or equivalent experience.  
• Continuing professional development and course studies in Quality Assurance Systems and Regulatory Affairs applicable to medical device manufacturing.  
• 12 years of experience in quality engineering, managing quality assurance and quality control programs in a manufacturing environment, with at least 7 years in the medical device manufacturing industry.
• Thorough knowledge of applicable U.S. FDA and international quality system and product approval requirements essential.
• Technical File and CE Mark preparation and submission.
• Class II Medical Device Sterilization Method Validation and Product Packaging Qualification.
• Electronics, embedded microprocessors, software life cycle, injection molding and electronic assembly practices.
• Excellent organizational, written and oral communications skills.
• Ability to lead and perform QSR activities to support new product development and current manufacturing.
• Ability to design, document, and implement quality assurance/control procedures that meet regulatory requirements in a cost-effective, value-adding manner.
• Knowledge of QSRs, ISO 13485 and MDD requirements.
• Ability to learn, translate, and effectively communicate regulatory requirements to others.

Responsibilities:
Management Responsibilities:
• Manage Quality Assurance and Quality Control associates and functions.
• Ensure the establishment of Quality Policy, Manual and Objectives
• Prepare and hold Management Reviews
• Define, document, implement and maintain Systems for:
- Internal QSR Audit System
- Internal and External QSR Audits and Inspections

Design Control:
• Ensure that adequate Design Control Procedures are defined, documented, implemented and maintained.
• Monitor and report the effectiveness of the Corrective and Preventative Action (CAPA) Design Control System.
• Define, document and ensure compliance with and effectiveness of procedures for:
- Non-Conforming Material
- Quality Problems
- Product Complaints, Medical Device Reporting and Vigilance Reporting
• Ensure adequate failure investigation, root cause analysis and statistical methods are used in CAPA systems.
• Ensure Service, Repair and Preventive Maintenance Systems meet CAPA requirements.
• Ensure the establishment and proper implementation of adequate data collection methods.
• Report the results, trends, actions and effectiveness of CAPA Systems.

Production and Process Controls:
• Ensure that processes are adequate to produce devices that meet applicable specifications.
• Establish adequate monitoring and control of processes to ensure device compliance to specifications.
• Establish statistically valid sampling plans and test methods.

Records, Document and Change Controls:
• Establish and maintain adequate and effective Records, Document and Change Control Systems.

Facilities and Equipment:
• Ensure adequate systems to document, maintain and control facilities and equipment to meet QS requirements.

Materials Controls:
• Ensure Material Handling and Control systems and procedure are adequate to meet QSR requirements.

Other specific areas of responsibility:
• Quality System training
• Supplier Quality System
• Calibration System
• Sterilization and Clean Room Validations
• Product Complaints including:
-Overall System management
-Failure investigation
-Root Cause analysis
-Returned Product Analysis
-MDR and Vigilance Reporting
• Label Creation and Control, domestic and foreign

Physical Requirements:
• Light occasional lifting (less than 30 lbs.).  Routine office duties including computer keyboard use.  Occasional travel demands.

Submit cv and salary requirements to: careers@inovio.com