Assistant Manager developing solid oral dosage forms to support Apotex's product pipeline. Leading research and development activities while ensuring compliance with industry regulations.
Responsibilities
Responsible for developing solid oral dosage forms for assigned projects or product categories by leading development activities to support the company product pipeline.
Develop experimental approaches and will be responsible for analyzing scientific results from experiments.
Generating accurate, reliable data by following established procedures and practices to support product development.
Responsible for formula optimization experiments and process optimization trials by employing the concept of Quality by Design (QbD).
Create the design space, Identification of Quality Target Product Profile (QTPP), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs) and its effect on drug product Critical Quality Attributes (CQAs).
Collaborate & participate meetings with multidisciplinary teams to resolve complex product development issues.
Ensure compliance with current Good Manufacturing Practices (cGMP), Apotex policies and Quality Systems, and all applicable regulatory agencies.
Requirements
Master’s degree or Ph.D. in Pharmaceutics or Pharmaceutical Technology or related science.
Excellent working and theoretical knowledge of different pharmaceutical solid oral dosage forms such as immediate release, controlled release & delayed release dosage forms
Detailed understanding of the theoretical principles for major manufacturing processes and equipment.
Excellent knowledge of excipient properties and their use in formulation development.
Strong verbal and written English communication skills.
Excellent organization and report writing skills.
Experience using computers, preferable in MS Office (Word, Excel, PowerPoint, Outlook).
Well-developed interpersonal and team skills.
Ability to work independently and make responsible and accountable decisions.
Knowledge of GMP, GLP, GDP, Safety, FDA and TPD guidelines.
Multi-tasking and project management skills.
10-15 years of working experience in a pharmaceutical development environment with related experience in formulation development of solid oral dosage forms for regulated market, scale up and/or technology transfer.
Benefits
Accommodation for applicants with disabilities as part of its recruitment process
Yield & Monetization Manager optimizing pricing and inventory for Retail Media at Valiuz. Focused on maximizing revenue and ensuring business model coherence across business units.
Manage APHSA’s grant portfolio and initiatives focused on SNAP. Lead cross - functional collaboration and ensure compliance with grant objectives while supporting members' needs.
Stoffstrommanager responsible for developing optimal waste utilization pathways in Germany. Focused on contract finalization and continuous market observation for secondary raw materials.
Country Manager leading the local branch of a global energy distribution company in Peru. Main responsibility is to establish and grow the local market from scratch.
Country Manager leading Smart Energy & Utilities operations in Chile, focusing on market expansion and business development. Responsible for overall commercial cycle and international coordination.
Equipment Execution Manager managing the lifecycle of operational assets at Signature Aviation. Optimizing performance and ensuring compliance and training in a high - performance environment.
IT Senior Manager leading end - to - end migration of SAP systems to S/4HANA at Carmeuse. This pivotal role involves ensuring integration, business continuity, and value realization in enterprise systems.
Resource Manager optimizing human resources and processes at BearingPoint Netherlands. Collaborating on workforce planning and recruitment strategies in a dynamic consultancy environment.
EUC Manager at DP World Oceania shaping secure, modern, and resilient digital workplaces. Leading EUC strategy while ensuring compliance with global cybersecurity standards.
Engagement Manager building and maintaining strategic relationships with insurance clients. Driving top - of - funnel engagement and identifying new opportunities within insurance organisations.