Scientist/Sr. Scientist, Analytical Development

Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions.  We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy.  We are looking for passionate and enthusiastic individuals who share our excitement for this mission.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist/Sr. Scientist, Analytical Development located at our Brisbane office. 

The individual will provide strategic direction, tactical oversight and technical expertise for all analytical activities and will play a key role in trouble shooting and change management at external CMO/CROs.  In addition, apply a science-driven, phase-appropriate and risk-based analytical development strategy to support projects from discovery, clinical development and commercial phases of development.

Essential Duties and Responsibilities

• Responsible for analytical method development, validation and transfer for drug substances, drug products, GMP starting materials, intermediates, in-process controls to enable clinical material manufacturing, process knowledge capturing, registration batch production and stability study monitoring.
• Support GMP related activities such as release, stability testing as well issue/maintain specifications and OOT/OOS investigation.
• Manage analytical and quality control activities at CROs/CMOs to complete the release and stability testing in timely manner.
• Author, review, and/or approve SOPs, test methods, specifications, protocols, reports, OOT/OOS investigations and other controlled documents as needed.
• Author, review and/or approve analytical and QC sections of regulatory submissions.
• Coordination and management of stability programs and data.
• Oversight of all release testing of all raw materials, intermediates, APIs and DPs.
• Routinely interface with other functions, such as Contract Manufacturing, Pharmaceutical Technology, Quality Assurance, Regulatory, Clinical and Pre-clinical Sciences, Supply Chain and Project Management.
• Evaluate and implement new technologies and practices internally and through CROs/CMOs and be familiar with current industry best practices.
• Ensuring all QC procedures are in compliance with ICH, FDA and EU guidelines, GMPs and internal/CMO SOPs.
• Perform other duties as assigned.

Core Competencies

• Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
• Exercise good judgment and make decision that is appropriate for the organization
• Results-driven, take initiative and ownership to accomplish work
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
• Strive for continuous improvement and embrace innovative ideas in daily work

REQUIREMENTS (Education and Experience)

• B.S. degree in Analytical Chemistry or M.S. degree in Analytical Chemistry with extensive industry experience.
• Minimum 8+ years of relevant experience in biotech or pharmaceutical industry
• Deep knowledge of the modern practices of analytical chemistry, quality control, GMP principles, USP/EP standards, ICH guidelines, with wide-ranging experience and understanding of small molecule and/or small peptide drug development and manufacturing.
• In-depth knowledge and hands-on experience with HPLC, GC, MS, FT-IR and wet chemistry method development and testing.
• Ability to interpret and apply cGMPs, USP/EP standards, regulatory requirements, ICH guidelines and industry best practices.
• Proven experience in working with external resources (CMOs, CROs, etc.) as well as collaborating internal teams.
• A strong track record of scientific achievements including external publications and presentations.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

If you require any accommodations, please email careers@myovant.com.

Equal Employment Opportunity