Manager, Drug Device Combination Products

Job Summary

Responsible for providing scientific expertise and technical guidance to the team in the specific technology areas for drug device combination products, and more specifically (but not exclusively) in the area of injectables, nasals, opthalmics, inhalation, topicals development,. In this role, the incumbent will be expected to develop close working relationships with the developments partners and Apotex subject matter experts.

Job Responsibilities

• Will serve as the Apotex technical subject matter expert within Global R&D team for generic projects, specifically for (but not exclusively) developing complex drug delivery devices from early phase through commercialization for combination product dosage forms such as sterile pre-filled syringes, pen devices, auto injectors, topical pumps, nasals, inhalation products, opthalmics.
• Create of Design Control deliverables to comply with medical device and combination device regulations.
• Create and / or Review Design & Development Plans, Traceability Matrices, Design/ User/ Process FMEA Risk Assessments, Design Verification and Validation Testing, and Design History Files.
• Review of User Needs, Design Inputs, Design Outputs, Design Verification, Design Validation, and Design Transfer following the principles of Design Control for each project.
• Assessment of manufacturing processes, and the development of test methods for combination products.
• Development and commercialization activity in compliance with applicable processes / procedures, standards and regulations including Design Controls, Risk Management, Human factors engineering, primarily using either a Device or cGMP stream-lined Regulatory approach.
• Manufacturing and Complaint Investigations
• Assessment of device changes during development and after commercialization
• Provide guidance to design E/L studies and evaluation of E/L data
• Represent Apotex during regulatory inspections in relation to compliance initiatives within R&D/R&D QA.
• Regular participation in all strategy and decision-making meetings for all internal and external projects.
• Demonstrates necessary interpersonal skills to effectively and efficiently work collaboratively with a broad range of colleagues, international partners and vendors.
• Participates in the technical analysis of all potential new products as part of the due diligence process.
• Provides effective leadership and management of technical project-related issues.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education :
  • Minimum Bachelors degree (BSc) with at least 10 years experience in an R&D environment, preferably in a pharmaceutical development environment. Masters degree or PhD  in Pharmacy, Pharmaceutical Technology, science or engineering, and at least 2 years experience in a senior or supervisory role will be preferred.
• Knowledge, Skills and Abilities
  • Excellent working and theoretical knowledge device engineering and design controls, regulatory compliance requirements including but not limited to US FDA - CFR 21 820, ASTM, ISO.Knowledge and experience in pharmaceutical processes and equipment
  • Ability to communicate complex technical and regulatory information concisely with external service providers in a professional manner
  • Possesses exceptional organizational, interpersonal/team and report writing skills.
  • Demonstrated proficiency in written and verbal English communication.
  • Capable of multitasking in a fast-paced, rapidly changing work environment with minimal direct supervision.
  • Knowledge of GMP, GLP, Safety, FDA,TPD and EU guidelines
  • Develops solutions and implements action plans for identified issues to mitigate risks, informing and escalating as required
• Experience
  • At least 10 years experience in an R&D environment, preferably in a pharmaceutical development environment.
  • Candidates with at least 2 years experience in a senior or supervisory role will be preferred.