Northreach

Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.. 4+ years of experience in Analytical Dev for Cell Therapy or Protein based products, industry is preferred (M.S. with significant industry experience will also be considered). Experience transferring to quality (qualification/validation) and tech transfer to commercial settings.. Strong experience managing external manufacturing operations at CMO's/CRO's/CDMO's in relation to bioassays such as ADCC, CDC, ELISA, SPR (Crucial), and Cell-based binding assays.. Extensive expertise in analytical development and troubleshooting related to biologics, with proficiency in various methodologies such as chromatography, immunoassays, residual analysis, and cell-based assays.

principal scientist

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth. Responsibilities<ul><li>Provide support for the management of outsourced analytical methods across a global network of vendors involved in the manufacturing of commercial and clinical biopharmaceutical drug substances and drug products.</li><li>Provide oversight and expertise for external manufacturing operations relating to bioassays such as ADCC, CDC, ELISA, SPR, and Cell-based binding assays.</li><li>Assist in shaping the strategy and effectively oversee the execution of assay validation, transfer, optimization, and development processes that align with the needs of commercial and clinical manufacturing.</li><li>Collaborate with colleagues in Quality and Manufacturing to facilitate the analysis of data related to various testing phases, such as lot release testing, in-process testing, stability testing, stability analysis, characterization, and assay qualification/validation.</li><li>Oversee and manage both development and Good Manufacturing Practice (GMP) analytical work conducted in external laboratories.</li><li>Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.</li><li>Coordinate efforts with compliance groups, including QC testing, QA, and regulatory teams, to ensure alignment with regulatory standards and quality assurance.</li><li>Conduct in-depth analysis and trend evaluation of testing results, presenting findings in a clear and data-driven manner, and proposing actionable solutions based on these insights.</li><li>Author and review technical reports and other documentation in a clear and concise manner, ensuring that all information is accurately conveyed.</li></ul> Qualifications<ul><li>PhD in Biology, or related area. 4+ years of experience in Analytical Dev for Cell Therapy or Protein based products, industry is preferred (M.S. with significant industry experience will also be considered)</li><li>Bench experience with Cell-based assays and assay progression.</li><li>Experience transferring to quality (qualification/validation) and tech transfer to commercial settings.</li><li>Experience in overseeing outsourced analytical tasks within the pharmaceutical development or commercial sector, encompassing method development, validation, and transfer processes.</li><li>Strong experience managing external manufacturing operations at CMO's/CRO's/CDMO's in relation to bioassays such as ADCC, CDC, ELISA, SPR (Crucial), and Cell-based binding assays.</li><li>Knowledgeable about cGMP (current Good Manufacturing Practice) requirements pertaining to the analysis of biopharmaceuticals.</li><li>Demonstrated experience in managing both development and GMP work in external analytical labs (or in house manufacturing lab in GMP environment).</li><li>Extensive expertise in analytical development and troubleshooting related to biologics, with proficiency in various methodologies such as chromatography, immunoassays, residual analysis, and cell-based assays. Adaptability to new assay modalities is essential.</li><li>Possesses a robust scientific mindset and the ability to skilfully interpret data to construct and convey insights into assay and product behaviour. This proficiency enables the formulation of data-driven proposals and recommendations.</li><li>Acquainted with statistical analysis and the principles of statistical process control.</li><li>A proactive attitude, capable of addressing challenges effectively, and a willingness to be part of a dynamic, team-oriented environment within a small but expanding biotech company, offering diverse opportunities for personal and professional development.</li></ul> Desired Experience<ul><li>Flow Cytometry</li><li>Cell Therapy</li><li>Molecular Biology/BIology</li></ul> Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.

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