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Senior Scientist- Biologics DS development
2 days ago
About the position
Key Responsibilities
• Analytical Method Development: Develop and validate analytical methods to support biologics development.
• Supervision of CDMO/CROs: Oversee analytical development and characterization activities conducted by contract development and manufacturing organizations (CDMO) or contract research organizations (CRO).
• Biologics Development and Industrialization: Assist in the development and industrialization processes for biologics.
• Process Development and Scale-Up: Participate in the development and scale-up of both upstream and downstream processes.
• Non-GMP Testing: Conduct in-house non-GMP testing as required.
• Regulatory and QA Interaction: Interface with Quality Assurance (QA) and regulatory functions to ensure compliance and facilitate product development.
• Project Management: Manage and coordinate project activities, ensuring timely and successful project delivery.
Your profile
Candidates should have substantial experience in one of the following areas: 1. Upstream Process Development and Scale-Up: Experience in developing and scaling up cell culture and fermentation processes. 2. Downstream Process Development and Scale-Up: Expertise in purifying and scaling up bioprocesses. 3. Analytical Development/Validation: Proficiency in developing, validating, and transferring analytical methods. 4. Drug Product SME (Subject Matter Expert): In-depth knowledge of drug product development, including formulation and stability. 5. CMC (Chemistry, Manufacturing, and Controls) Expertise: Strong background in CMC, Qualifications
• Advanced degree (BSc, MSc, PhD or equivalent) in Biochemistry, Biotechnology, or related field.
• Extensive experience in biologics development within the pharmaceutical industry.
• Proven track record in project management and leading cross-functional teams.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
If you are excited about this opportunity and meet the qualifications, don't hesitate to apply. We will reach out to discuss your background, ambitions, and how you could fit into the organization. Join us on this exciting journey and contribute to the development of cutting-edge biologics. Apply now and embark on a new chapter in your career
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