Technology Transfer Specialist

Description:

The Technology Transfer Specialist (TTS) is a key contributor in the successful transfer of process and product knowledge from lab scale to commercial scale plant production. The TTS will possess a detailed knowledge of the chemistry involved and existing process equipment to develop and achieve the best process fit for every new product introduction. The TTS is a key communication link between the key stakeholders of a Technology Transfer project (R&D, TS, Operations and Engineering). The TTS will work closely with the Engineering and Technology Transfer teams to identify new equipment that is required as part of the Technology transfer project. The TTS will also work closely with R&D and synthetic chemist to identify key quality and safety parameters and ensure the process equipment is capable of achieving these parameters on scale up. . Strong attention to detail and the ability to track multiple projects simultaneously are necessary. The successful candidate will take an active role in improving performance and efficiency to ensure good quality in manufacturing.

Key Responsibilities

Works independently or as part of a team with minimal supervision, to complete job related tasks and projects in a safe, compliant and efficient manner.
Provide hands-on support in process development/scale-up of new chemical entities in both lab and plant.
Design and conduct experiments to investigate the impact of reaction conditions on scale-up processes.
Assist in coordinating technology transfer of manufacturing processes between sites.
Identify solutions, including process analytical technologies which lead to robust process control.
Prepare technical reports that support scale-up activities and process improvements.
Review manufacturing batch records and protocols and participates in the training of operators and technicians in new processes and operations.
Applies scientific and engineering principles for research programs involving product development, processing, manufacturing technology, and quality control.
Maintains constant communication with cross functional groups to assist projects from concept through commercialization.
Responsible for documentation to ensure the consistent manufacture of new products; including batch records, production instructions and validation.
Maintains accurate records of all development projects.
Troubleshoots problems with manufacturing processes and optimizes development processes.
Experience with or ability to master the use of modern research tools such as Optimax EasyMax, and in-situ process monitoring.
Evaluates equipment and processes to ensure compliance with safety and environmental regulations.
Lead risk assessment and FMEA type studies to anticipate and prevent difficulties that may occur on scale up of processes e.g mass transfer, mixing and heat transfer issue etc.
Develop and improve cleaning procedures for product contact plant equipment used in commercial processes.
Develop (with Analytical chemist and Synthetic chemist) appropriate cleaning limits to verify product contact equipment is clean i.e. product residues are below specified limit post cleaning procedure.
Management of on-site contractors, and ensures compliance with site procedures. Issues and oversees appropriate work permits and controls are in place.
Ensure all waste is disposed of in accordance with licencing requirements, including proper segregation and storage of waste.
Advocate of highest safety and quality compliance on site, proactively identifies and resolves any such issues. Participates in site safety initiatives and planning.
Ensures work and ancillary areas, plant and equipment etc. are clean and maintained to the highest standards at all times.
Fully engages in programmes such as Continuous Improvement, Total Productive and Maintenance (TPM), 5S, Lean, Six Sigma, Total Quality, Self-directed Teams etc.
Attend and complete all training and development as requested and ensure training compliance at all times.
Lead and or participate in process, quality and safety, inspections, audits, deviation investigations, HAZOP’s, change management, root cause analysis and development of solutions.
Provides On-Call support and attends site Call-Outs, outside of normal working hours.
Any other duties or responsibilities relevant to the role of Technical Transfer Specialist.

Education, Knowledge & Experience

Bachelor’s Degree in Chemistry or Chemical engineering or a related field with 5+ years of experience, preferably with a Master’s degree.
Chemical or Pharmaceutical experience is preferrable technical knowledge of production processes and operations.
A combination of technical service, product/process development, processing laboratory techniques and regulatory requirements in chemical, pharmaceutical or related industries.
New Product/Process Introduction (NPI) experience is essential.
Project management experience is essential, PMP certified preferably.
Ability to read piping & Instrumentation Diagrams (P&ID’s) would be preferable.
Experience with DOE in support of scale-up of development processes at manufacturing sites preferred.
Solid analytical skills using tools such as statistics, downtime tracking, mechanical history, project planning, etc. when identifying opportunity areas.
Process safety knowledge and experience including ATEX regulations (EX/IS systems), HAZOP’s and Risk Assessments.
High level computer proficient for example, MS Word, Excel, PowerPoint, Project, LIMS etc.
Experience in operational excellence, continuous improvement, lean, six-sigma certified, project management, change management would be an advantage.
Must hold a full driving licence.

Skills & Behaviours

Adheres to all site and corporate procedures.
Excellent level of attendance and punctuality is required.
Good work ethic and ability to meet assigned tasks, responsibilities, objectives and timelines.
Excellent organisation and time management; is organised and can prioritise business demands.
Maintains good working relationships with all colleagues, and treats colleagues with dignity and respect.
Communication: excellent listening, written, verbal, presentation and interpersonal skills (ability to communicate effectively at all levels).
Attention to detail and high level of reporting accuracy with respect to all aspects of the role.
Proactive, self-starter, positive attitude, flexible and open to change, willingness to learn and take on additional responsibilities.
Methodical and structured approach to decision making.
Exercises discretion and confidentiality at all times, in relation to all Company matters.
Excellent project management, problem solving, creative thinking and analytical skills.
Supports and engages in change initiatives and continuous improvement programs.
Advocates and supports compliance and safety culture on the site.