Senior Analytical Specialist (Respiratory)
Location: Pabianice
Responsibilities
- Involvement in inhalation projects, study of drug substances and dosage forms, starting from early development through to transfer to pharmaceutical production in the scope of:
- development, validation and implementation of new analytical methods, release and stability analysis in accordance with GxP standards and current regulatory requirements (EU, FDA),
- development of analytical documentation necessary to perform pilot production - Specification, Analytical Instructions and performing analyzes during this production, as well as during stability tests"
- Main responsibilities are to design, plan, perform, interpret and report results of analytical experiments for the preparation and timely delivery of inhalation drug product
- Strong knowledge of relevant GLP and GMP regulations and policies are desirable
- Experience in using a variety of instrumentation techniques e.g. DUSA, NGI and other applicable analytical instruments: PSD, UHPLC, KF Highly communication and presentation skills; evaluates data and contributes in problem solving
- Generates regulatory documents and internal documents for quality control, operations instructions and reports
Requirements
- Minimum 5 years of directly related experience as analytical senior specialist (including inhalation drug products) in pharmaceutical industry
- Good knowledge of MS Office software and knowledge of Empower software is prerequisite
- Strong knowledge of relevant GLP and GMP regulations and policies is desirable. Knowledge of registration procedure and Dossier Registration eCTD (Module 3) creation thorough knowledge of state-of-the-art analytical instrumentation/equipment for broad field of applications, mainly connected with inhalation drug product development e.g. DUSA, NGI
- Experience in the analytics of inhalation dosage forms is advantageous
- A track record in HPLC / UHPLC method development
We offer
- Full time contract of employment
- Private medical care for a co-worker and family (rehabilitation without limits, treatment option for a dental and Senior package on preferential terms)
- Relocation package
- Co-financing of Allianz group insurance, option for a spouse/partner
- Health package for 5 (cyclical flu vaccinations, cafeteria of preventive examinations, state prevention campaign, COVID tests, mental health support)
- Benefits from the Social Benefits Fund (points in the benefits cafeteria)
- jubilee awards
- Employee recommendation program (the possibility of using financial bonuses for recommending people to work)
- Company events, e.g. Festival of Values, Festival of Science
