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Group Product Upgrade Manager

Purpose:

  • To lead and manage technical aspects relating to the technology transfer of upgraded products and new products into the manufacturing facilities of Aspen.
  • Technical management of the upgrade of Aspen’s intellectual property in order to support product compliance in local and international regulatory territories.
  • Management of the SA Ops stability program.
  • To support the Aspen Resource Project, ensuring evaluations are performed in order to facilitate raw material source changes. Collectively, to maintain Aspen’s technical IP to appropriate levels of local and / or international compliance.

Key Responsibilities:

Product Maintenance/ IP Upgrade

  • Provide technical management of the maintenance (or upgrades when required) of the Aspen PE / EL / SVP product range (300 – 400 products)
  • Ensure raw materials, products, analytical methods and specifications are upgraded in a timely manner in support of local and international regulatory submissions or product maintenance.
  • Ensure that the appropriate regulatory requirements, as provided by Aspen Regulatory Affairs, are adhered to and / or incorporated into the upgraded products.
  • Ensure that the necessary documentation is generated and logistical planning occurs with the Aspen manufacturing sites to ensure manufacture of the submission batches
  • Ensure compilation of relevant production, stability and analytical documentation for submission to Aspen Regulatory Affairs

 

Technical Transfer

  • Manage the technical aspects (test methods, specifications, stability, product testing, project management, datapack compilation) to ensure successful transfer of upgraded Aspen products and new products within and between the different Aspen manufacturing sites.
  • Ensure transfer projects and optimisation projects have agreed milestones that are reviewed regularly by a cross-functional team
  • Pro-active problem solving, effective communication and negotiation to ensure milestones are met within overall project time lines

 

New Product Development/ Redevelopment of Products/ Processes

  • Manage the scale-up process development of in-house developed products at the Aspen PE / SVP sites, and re-development of selected existing Aspen products and processes in the Group Product Upgrade department
  • Manage the technical evaluation process to determine manufacturability of these products at Aspen manufacturing sites
  • Ensure effective evaluation of manufacturing equipment, required batch sizes and technical ability to manufacture
  • Ensure successful scale-up in preparation for process validation activities
  • Ensure effective transfer of manufacturing know-how to Technical Support department
  • Ensure compilation of production, stability and analytical documentation for submission to Aspen Regulatory Affairs

 

Stability

  • Manage and take responsibility for the SA Ops Aspen Stability program (in-house and outsource stability trials)

 

Raw Material Evaluations

  • Ensure the successful management of technical raw material source change evaluations.
  • Manage scheduling of new raw material laboratory scale trial batches in the Formulation Development Laboratory
  • Ensure completion and supervision of new raw material trial batches in the Formulation Development Laboratory
  • Ensure management of analytical data processing and completion of new raw material evaluation reports
  • Provide feedback regarding laboratory-scale trial outcomes to Resource Project Team for the purpose of planning further trial batch activities at a production scale
  • Ensure management of the technical aspects of the source change scale-up trial / submission batches and ensure demonstration of product equivalence in support of a success regulatory approval.

 

Troubleshooting

  • Investigate and recommend effective solutions to issues arising during product maintenance, IP upgrade, new product development, product re-developments, and tech transfers.
  • Solving of problems through analytical processes.

 

Change Management

  • Keep up-to-date with new technology and regulatory developments
  • Advise and consult on recommended changes to production processes to optimise production performance, e.g. Oven to FBD conversion, organic to aqueous solvent coating conversions, Bear to Gral conversions
  • Ensure necessary trial batches are prepared to accommodate the recommended changes
  • Manage implementation of these changes via the regulatory process if applicable.

Project Management

  • Manage the generation of project plans with clear definition of the project brief (goals, scope and milestones)
  • Utilise resources as per strategic project plan for maximum productivity
  • Assess adherence to time frames
  • Problems are creatively resolved to maximise the implementation of the project
  • Assess variance from project plan
  • Projects are completed according to customer specification, time, quality and budget constraints
  • Liaison with external entities to identify interventions to bridge the gaps identified
  • Advise and consult on recommended changes to production processes to optimise production performance, e.g. Oven to FBD conversion, organic to aqueous solvent coating conversions, Bear to Gral conversions

Tracking and Reporting of Projects with status reports / corrective action steps when projects are running behind schedule

Job requirements: 

  • Pharm
  • Management diploma / degree would be advantageous
  • Business Management qualification
  • 10 - 15 years product development / technical transfer management experience in a pharmaceutical environment
  • 4 – 6 years Management experience
  • Experience in managing laboratory processes would be advantageous
  • Budgeting and trend analysis and report writing experience
  • Coaching, leadership and mentoring skills
  • Proven experience of strategy operationalization and implementation
  • Computer literate: MS office essential and Project management

Reference Number: 

GPUManager838

Company: 

Aspen

City: 

Port Elizabeth

Country: 

ZA

Salary: 

Market Related

Job Type: 

fulltime

Industry: 

Pharmaceutical And Medical/Healthcare