Biotechnology Development Specialist

Job Summary: We are seeking a highly skilled Biotechnology Development Expert to join our team. This role involves developing and implementing strategies for the creation of monoclonal antibodies, as well as conducting research and analysis to support the development of new biologics.

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• Develop and implement CMC strategies for biologics development programs">
• Conduct extensive literature research and analysis of scientific documents">
• Act as liaison with Regulatory Teams">
• Collaborate with internal and external stakeholders to ensure timely and successful execution of CMC activities">
• Manage CMC activities related to process development, manufacturing, analytical method development, and validation">
• Review and approve CMC-related documents, including protocols, reports, regulatory submissions, and manufacturing records">
• Ensure compliance with regulatory guidelines and standards, including FDA, EMA, and ICH guidelines">
• Identify and mitigate risks associated with CMC activities to ensure project timelines and deliverables are met">
• Provide technical advice and direction regarding adherence to regulatory standards for the manufacturing processes of biologics, analytical methodologies">

Requirements:

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• Master's or Ph.D. degree in Biochemistry, Biology, Biotechnology, Chemistry, or a related field">
• Minimum of 5 years of experience in development or regulatory department, with a focus on CMC">
• Understanding of biologics manufacturing processes, including cell culture, purification, and aseptic processing">
• Experience with regulatory submissions and interactions with regulatory agencies (FDA, EMA, etc.)">
• Experience with statistical analysis for scientific data">
• Excellent project management skills, with the ability to interact with cross-functional teams and manage multiple projects simultaneously">
• Strong communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders">
• Experience working in a similar role in a CMC function for Biosimilar development will be considered an asset">
• Knowledge of GMP regulations and quality systems is required">
• Excellent written and oral communication skills in English">

Benefits: Our company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging work environment.

Key Responsibilities:

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2. Developing and implementing effective CMC strategies to meet project timelines and deliverables">
3. Providing technical guidance and support to internal and external stakeholders to ensure successful execution of CMC activities">
4. Collaborating with cross-functional teams to develop and execute CMC strategies for biologics development programs">
5. Ensuring compliance with regulatory guidelines and standards, including FDA, EMA, and ICH guidelines">
6. Managing CMC activities related to process development, manufacturing, analytical method development, and validation">
7. Reviewing and approving CMC-related documents, including protocols, reports, regulatory submissions, and manufacturing records">

What We Offer: As a Biotechnology Development Expert, you will have the opportunity to work on exciting projects that involve the development and implementation of cutting-edge biotechnology solutions. You will be part of a dynamic team that values collaboration, innovation, and professional growth. If you are passionate about biotechnology and committed to excellence, we encourage you to apply for this role.

We offer a collaborative and innovative work environment that fosters creativity and professional growth. Our team is dedicated to developing and implementing cutting-edge biotechnology solutions that make a positive impact on society. Join us and be part of a dynamic team that values teamwork, innovation, and community engagement.