Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 320 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).
The Technical Services Process Development Scientist will act as a SME for the development of drug product formulations and of production processes. The role holder will report to the Technical Services Manager and will provide support in achieving company goals with a specific focus on responsibilities related to the Technical Services function of developing production processes from laboratory to commercial scale. The role holder will work closely and collaboratively with other members of the Technical Services team, as well as business development/commercial value streams to achieve goals
Key areas of responsibility (include but not limited to):
* Foster innovative thinking within the Technical Services function and to develop formulations and production processes in a timely fashion according to stakeholder expectations.
* Identifying, assessing, recommending and implementing process controls to ensure production of finished product that will meet patient needs, during initial development up and batch scale up.
* Execute and/or oversee the design and development of production processes that are built on sound scientific, regulatory, Quality by Design (QbD), process validation and product development principles.
* Assist in the improvement of existing drug product formulations and production processes within the organisation by retrospective application of sound scientific, regulatory, QbD, process validation, and product development principles.
* Champion the use of QbD and scientific thinking in developing innovative drug product formulations and production processes while maintaining a comprehensive knowledge of formulations development disciplines through research and scientific literature.
* Identifying, assessing, recommending and implementing internal and external opportunities to broaden Pinewood Healthcare's technical/scientific capability.
* Work to create an excellence/SME culture within that is focused on innovation, lean and robust formulation development, as well as continuous improvement.
* Where required, represent the Technical Services team in all relevant meetings, for example product pipeline steering committee meetings.
* Oversight of relevant development manufacture from pilot to commercial scale in production.
* Provide process transfer support for technical transfers.
* To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
* Any other duties as deemed appropriate and as designated by the Technical Services Manager.
Key Requirements:
* BSc in Science or Engineering or related discipline, post graduate qualification highly desirable.
* At least 5 years' proven experience in a process or formulation development environment which significant experience in studies that include drug and material characterisation and selection.
* SME level knowledge of QbD and pharmaceutical development processes.
* Knowledge of unit processing and scaling manufacture from pilot to commercial scale.
* Demonstrated capabilities in project management and technical leadership of complex product/process developments, at least two years is highly desirable.
* Demonstrated ability to be self-motivated and focus others with respect to implementing identified improvement initiatives.
* Have demonstrated effective research skills, including the critical review of the scientific literature.
* Excellent technical writing skills.
* Outstanding organisational and time-management skills.
* Exceptional team player with the ability to leverage/collaborate effectively with internal and external stakeholders.
* Excellent written and verbal communication and interpersonal skills.
* Comfortable working in a busy, fast paced regulated manufacturing environment.