Analytical Development Bioassay Supervisor

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Analytical Development Bioassay Supervisor

DEMO Pharmaceuticals

Athens, Greece

Description

Demo leads the way in the Greek pharmaceutical market with major investments in Biotechnology

We are building a prototype unit for the development of monoclonal antibodies
We are creating a contemporary Research and Development Center for biotechnology
We are starting research for three finished pharmaceutical products with monoclonal antibodies
We are establishing a Biotechnology Academy to train young scientists. Biotechnology is becoming part of our lives.

As a result, we are currently looking for a high caliber Analytical Development Bioassay Supervisor.

Main duties and responsibilities:

Lead and manage a team of scientists and technicians to conduct bioassay, ELISA and SPR experiments in support of biosimilar development programs.
Develop and qualify methods for the characterization and quantification of biosimilar products, including potency, cell-based assays, DNA content, ELISA and SPR.
Design experimental protocols and workflows to address specific analytical challenges related to biosimilar development, such as comparability studies, forced degradation studies, and stability testing.
Analyze data, interpret results, and provide scientific insights to guide decision-making in collaboration with cross-functional teams.
Maintain and troubleshoot for technique like potency, cell-based assays, DNA content , ensuring optimal performance and adherence to regulatory requirements.
Stay current with developments in advance technology and industry best practices, incorporating new methodologies and techniques as appropriate.
Contribute to regulatory submissions by preparing technical documents, assay validation reports, and other supporting documentation in compliance with regulatory guidelines.
Perform method qualification, optimization, and troubleshooting to ensure robustness, accuracy, and precision of analytical assays.
Interpret data and collaborate with mass spectrometry and biophysical scientists to elucidate structural and functional attributes of biosimilar molecules.
Contribute to regulatory submissions by providing analytical data, reports, and documentation in compliance with applicable guidelines and regulations (e.g., FDA, EMA).
Stay current with advancements in technology and methodologies, and actively participate in scientific conferences and publications.

Requirements

Experience, skills and qualifications required:

Ph.D. or M.S. in Analytical Chemistry, Biochemistry, or related field with
8+ years of industry experience in mass spectrometry, preferably in a biopharmaceutical or biosimilar development setting
Strong expertise in analytical techniques for protein analysis regarding their biological properties e.g. ELISA, Molecular biogy techniques, cell based assays, SPR, Q-PCR etc with a focus on protein characterization and analysis.
Proven leadership and project management skills, with experience supervising and mentoring scientific staff.
Proven track record of applying biophysical techniques to the analysis of protein therapeutics or biologics, preferably in a biotechnology industry setting.
Demonstrated ability to design and execute complex experiments, analyze data, and communicate results effectively to diverse stakeholders.
Familiarity with regulatory requirements for biopharmaceutical characterization, including ICH guidelines, FDA/EMA regulations, and industry standards.
Excellent written and verbal communication skills, with the ability to collaborate effectively in a cross-functional team environment.
Strong problem-solving abilities and attention to detail, with a commitment to delivering high-quality results on time and within budget.
Strong understanding of protein chemistry, biophysical characterization techniques, and regulatory requirements for biosimilar development.
Excellent problem-solving skills, attention to detail, and ability to work effectively in a fast-paced, collaborative environment.
Excellent communication skills and ability to present complex scientific concepts to diverse audiences.
Software knowledge like: excel, Data visualisation and statistics like: Graph Pad Prism, JASP, JMP or similar.
Operating sophisticated analytical equipment like: Spectrophotometer,DSC,DLS,SPR, FTI and CD.
Experience in quality system – GMP, GLP or Good Development Practices will be advantage.
Critical thinking & problem solving
Resilience and ability to work independently,
Good communication and team player,
Fast learner.