Co-Development Tech & CMC Scientific Leader (Injectable Product Development)

Job Summary

A member of a joint co-development team working with third party partners for the development and launch of generic products. Responsible for providing scientific expertise and technical guidance to the team in the specific technology areas for co-development pipeline projects, and more specifically (but not exclusively) in the area of complex sterile products such as protein and peptide development and production, peptide drug product development, sustained release formulations (small molecules and peptides), microsphere and polymer release formulations and process development of injectables and other dosage forms. In this role, the incumbent will be expected to develop close working relationships with the Co-development partner and Apotex subject matter experts.

Job Responsibilities

• Will serve as the Apotex technical point of contact within the co-development team for generic projects, specifically for (but not exclusively) protein/peptide or small molecule sustained release parenteral product development, related process and method evaluation, development and validation, related container closure studies and related bioequivalence studies.
• Will review and provide oversight from Apotex for the development, qualification and validation of all related in-process, DS release and DP release testing methods required for the development of the regulatory dossier and for ongoing commercial quality monitoring.
• Will participate in development and launch activities for codevelopment projects.
• Communicates development issues and works to resolve them in a timely manner.
• Tracks and reports development progress, providing input for development scope. Routine review and editing of all internally directed analytical methods development programs with external vendors.
• Regular participation in all strategy and decision-making meetings for all external CRO collaborations and projects.
• Participates in the writing and review of all Quality and CMC sections relating to product development, process development and analytical methods development, qualification, validation and comparability studies for all co-development 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 Apotex Co-Development due diligence process.
• Provides effective leadership and management of technical project-related issues.
• Provides expert advice in troubleshooting of all aspects of manufacturing and analysis. Identifies and resolves analytical method development or other analytical problems as required.
• Monitors process, progress and results of assigned responsibilities; prepares monthly reports.
• Participation in other technical assignments and internal projects as needed.
• 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) and preferably Masters degree or PhD in Pharmacy,  Biochemistry/Analytical Chemistry, Pharmaceutical Technology, science or engineering.
• Knowledge, Skills and Abilities
  • Excellent working and theoretical knowledge of sterile product development/manufacturing, protein/peptide development, complex injectable formulations and other pharmaceutical dosage forms.
  • Provide chemistry knowledge to support product formulation and process development activities.
  • Extensive knowledge and experience in pharmaceutical processes and equipment.
  • Demonstration, through work experience, of a broad understanding of analytical methods and the technical capabilities and practical limitations of state-of-the-art analytical instrumentation.
  • Ability to communicate complex technical and regulatory information concisely with external service providers in a professional manner
  • Computer literate with advanced knowledge of computerized chromatographic instrumentation and data systems.
  • 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
  • Minimum 5 years and preferably > 7 years experience in an R&D environment, preferably in a pharmaceutical development environment.