Overview:
Summary of job description:
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.
Responsibilities:
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 organization (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.
Other responsibilities:
* Supervise the work of Assay Development Scientists or Technicians
* 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.
Qualifications:
Educational requirements:
Education will be appropriate to specific job requirements. The following educational requirements are a minimum:
* 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
Experience and skill requirements:
Training and experience will be appropriate to specific job requirements. The following categories will be assessed in each case:
* 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
Location:
* This position is based in our Milton Park location and typically has a 5-day on-site expectation.
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