Lead / Manager – Downstream Process Development (Biosimilars)

Job Description

We’re Hiring: Team Lead / Manager – Downstream Process Development (Biosimilars) We are looking for an experienced and highly motivated professional to lead our Downstream Process Development team for biosimilars. This is a senior, hands-on role for candidates with proven industry experience. Please review the requirements carefully before applying. QUALIFICATION & EXPERIENCE • M.Sc./MTech. in Life Sciences with a minimum of 10 years of experience, OR • PhD with a minimum of 5 years of experience MANDATORY REQUIREMENTS The candidate must: • Have worked in biopharmaceutical industry R&D, specifically in downstream process development of biosimilars • Have excellent knowledge of the physicochemical properties of proteins and protein chemistry • Have proven, hands-on industry experience in protein refolding from inclusion bodies • Have a strong understanding of resin chemistries for IEX, HIC, GF and RP chromatography • Have hands-on experience with ÄKTA systems and XK, HiScale and BPG columns • Be capable of independently designing scalable downstream processes for different types of protein therapeutics • Have developed or contributed to downstream processes for:   – Large molecules such as monoclonal antibodies (mAbs)   – Medium-sized molecules such as growth factors and enzymes   – Small peptide-like proteins such as insulins and GLP-1 analogues • Be familiar with in-process, drug substance (DS) and drug product (DP) testing • Be familiar with ICH guidelines • Have an excellent understanding of data recording, data storage and documentation, including preparation of SOPs, STPs, BMRs and other technical documents • Have the ability to train and lead a team towards the company’s strategic goals in biosimilar development • Have experience working with cross-functional teams, including Upstream, QC, QA and Regulatory Affairs PLEASE NOTE Theoretical knowledge of protein refolding and chromatographic principles alone will not make a candidate eligible. Real, hands-on working experience in an industry setting is essential. Applications not meeting these criteria will not be considered. HOW TO APPLY Send your CV to careers@bycusbio.com with the subject line “DSP Team Lead – [Your Name]“. In your application, please briefly mention the molecules you have worked on and your specific hands-on role in their downstream process development.