Sr. Scientist Analytical Development
is responsible for developing, optimizing, qualifying, and validating analytical methods based on new and existing methodologies to qualitatively and quantitatively evaluate both drug substance and drug product, from preclinical through late phase clinical development. Analytical development supports drug substance/drug product release, process development, and characterization and/or stability testing of Replimune's clinical material. In addition, coordination of analytical development and analysis work at CMOs/CROs will be a significant portion of the duties of the Sr. Scientist Analytical Development. This position is based in our Milton Park location and typically has a 5-day on-site expectation. Key Responsibilities:
Manage the development, qualification and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances. Support release and stability testing performed in-house and at contract research organizations (CRO), and directing good manufacturing practices (GMP) investigations including deviation root cause analyses, corrective action preventative action (CAPA), and out of specification (OOS). Develop strategies for evaluating and implementing new technologies within Analytical Development. Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses. Involved in daily workings of the group and actively participate in method troubleshooting and data analysis. Supervise the work of Assay Development Scientists or Technicians. Act as Analytical Development (AD) representative for cross-function meetings/projects with manufacturing, Quality Assurance (QA), Regulatory Affairs, and external partners. Provide AD review and approval of SOPs, risk assessments, protocols, and reports. Provide regular updates of AD group activities to the Chief Operating Officer and other Replimune senior management. Minimum Qualifications:
A or B.S. degree in a relevant biological science. M.S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred. 5-10 years industry experience, preferably in a cGMP Quality environment. Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development. Thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations. Ability to interface effectively with management and other groups or project teams. Computer processing literacy and experience in statistical analysis. Excellent verbal and written communication skills. Good organizational skills. Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patients' lives depend on it. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.
#J-18808-Ljbffr
is responsible for developing, optimizing, qualifying, and validating analytical methods based on new and existing methodologies to qualitatively and quantitatively evaluate both drug substance and drug product, from preclinical through late phase clinical development. Analytical development supports drug substance/drug product release, process development, and characterization and/or stability testing of Replimune's clinical material. In addition, coordination of analytical development and analysis work at CMOs/CROs will be a significant portion of the duties of the Sr. Scientist Analytical Development. This position is based in our Milton Park location and typically has a 5-day on-site expectation. Key Responsibilities:
Manage the development, qualification and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances. Support release and stability testing performed in-house and at contract research organizations (CRO), and directing good manufacturing practices (GMP) investigations including deviation root cause analyses, corrective action preventative action (CAPA), and out of specification (OOS). Develop strategies for evaluating and implementing new technologies within Analytical Development. Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses. Involved in daily workings of the group and actively participate in method troubleshooting and data analysis. Supervise the work of Assay Development Scientists or Technicians. Act as Analytical Development (AD) representative for cross-function meetings/projects with manufacturing, Quality Assurance (QA), Regulatory Affairs, and external partners. Provide AD review and approval of SOPs, risk assessments, protocols, and reports. Provide regular updates of AD group activities to the Chief Operating Officer and other Replimune senior management. Minimum Qualifications:
A or B.S. degree in a relevant biological science. M.S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred. 5-10 years industry experience, preferably in a cGMP Quality environment. Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development. Thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations. Ability to interface effectively with management and other groups or project teams. Computer processing literacy and experience in statistical analysis. Excellent verbal and written communication skills. Good organizational skills. Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patients' lives depend on it. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.
#J-18808-Ljbffr
