Pinewood Healthcare is a leading developer, manufacturer and marketer of a range of generic, ethical and over-the-counter (OTC) healthcare products. The Company employs over 320 people across two sites in Tipperary and Dublin. Pinewood holds a licence from the Health Products Regulatory Authority (HPRA) to manufacture a range of pharmaceutical products including oral liquids, suspensions, creams and ointments.
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 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. Wockhardt has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).
The Technical Services Senior Formulation Scientist will have responsibility for performing and scheduling of formulation work, including laboratory scale batch manufacture, laboratory analysis, investigation reviews, supervision of batch manufacture in production, training and approval of documents. This position will require the holder to take an active and responsible role in routine GMP activities for example change control actions, CAPA actions, SOP maintenance, audits, investigations and reviews. The role holder will report to the Technical Services Manager and will provide support in achieving company goals. 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 Responsibilities (include but will not be limited to):
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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.
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Be aware of existing quality procedures.
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Comply with GLP/GMP and safety requirements at all times.
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Daily calibration of laboratory equipment and completion of associated paperwork. This includes performing the calibration, reviewing calibrations performed by other personnel and training personnel on this activity.
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Training of personnel on Formulation functions in line with relevant SOP's or training programs.
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Assist in the completion of formulation of new products to meet customer requirements.
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Product evaluation, formulation development and sample preparation. This includes scheduling the work within the formulation section and reviewing/approving work performed by other personnel.
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Maintaining samples and products development stock area.
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Internal product technical support.
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Employ skills in the design and data analyses of experimental studies.
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Perform laboratory analysis as required in the Technical Services department.
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Able to integrate experimental design expertise with technical knowledge.
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Execute experimental work to meet project goals and timelines. This includes preparation of reports or other supporting documents as required.
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Manufacture, packing and evaluation of stability samples for development pharmaceutics. This includes scheduling the work within formulation section.
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Work to tight production planning and deadlines.
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Assist compatibility studies and scale up processes.
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Oversight of relevant development pilot batch manufacture in production.
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Provide process transfer support for technical transfers.
- Take an active and responsible role in routine GMP activities for example change control actions, CAPA actions, SOP maintenance, audits, investigations and reviews.
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Work to create an excellence/SME culture within that is focused on innovation, lean and robust formulation development, as well as continuous improvement.
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Where required, represent the Technical Services team at relevant meetings.
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Any other duties as deemed appropriate and as designated by the Technical Services Manager.
Skills, Qualifications and Experience Requirements:
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BSc in Chemistry or related discipline.
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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.
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Knowledge of unit processing and scaling manufacture from pilot to commercial scale.
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Demonstrated capabilities planning, scheduling, monitoring and supporting project implementation in line with company goals and timelines.
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Demonstrated ability to be self-motivated and focus others with respect to implementing identified improvement initiatives.
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Have demonstrated effective research skills, including the critical review of the scientific literature.
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Excellent technical writing skills.
Personal Attributes:
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Outstanding organisational and time-management skills.
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Exceptional team player with the ability to leverage/collaborate effectively with internal and external stakeholders.
- Excellent written and verbal communication and interpersonal skills.
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Comfortable working in a busy, fast paced regulated manufacturing environment.
