The company is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. The unique SIMPLE Antibody platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
We are seeking an experienced Senior Scientist with at least 5 years of experience in biologics manufacturing and process validation. The role involves managing large-scale processes, engaging in key collaborations, and supporting critical projects with a focus on biologics. This is a highly challenging and rewarding opportunity to contribute to the next phase of large-scale biologics manufacturing.
THE POSITION
* Lead and manage large-scale manufacturing processes, with a focus on process validation and characterization;
* Solid experience in Drug Substance development;
* Apply in-depth knowledge of biologics to contribute immediately to ongoing projects;
* Excellent attention to detail with strong organizational skills for autonomous planning;
* Ensure adherence to Good Manufacturing Practice (GMP) standards throughout process validation and manufacturing activities;
* Validate protocols, gather inputs from key stakeholders, and provide critical insights to streamline validation processes;
* While experience in technology transfer is a plus, it is not mandatory. The role involves some exposure to tech transfer activities up to 2,000L;
* Act as a key contact point, partnering closely with Contract Manufacturing Organizations to drive project success;
* Engage in both upstream and downstream processes, gaining a comprehensive understanding of the entire biologics production cycle;
* Collaborate in a multi-functional project team, maintaining close communication and support with stakeholders.
REQUIREMENTS
* Advanced degree in Biotechnology, Biochemical Engineering, or a related field;
* A minimum of 5 years in large-scale biologics manufacturing, with hands-on experience in process characterization, validation, and GMP labs;
* Proven ability to work independently and take initiative in a fast-paced environment;
* Ability to handle both disposables and stainless steel in large scales (up to 6,000L);
* Demonstrate a proactive, problem-solving mentality and a willingness to go the extra mile to address challenges;
* This role requires experience only in biologics; experience in small molecules is not needed.
THE OPPORTUNITY
* Work with a team of talented professionals from diverse nationalities and backgrounds;
* Be part of a supportive team that thrives on mutual support and helping each other through stressful situations;
* Gain exposure to cutting-edge projects and the opportunity to work with industry-leading partners;
* Take on the key challenge of driving process characterization and validation efforts for high-impact biologics projects.
Please submit your CV through the form below and we will contact you shortly.
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