Note: The job is a remote job and is open to candidates in USA. Aurinia Pharmaceuticals Inc. develops innovative treatments for patients living with serious, rare autoimmune and inflammatory diseases, including LUPKYNIS for lupus nephritis. The Senior Manager, Analytical Development will lead analytical method development, validation, transfer, and technical support for drug substances and products while collaborating with internal teams and external CDMO partners. The role also supports CMC development, regulatory filings, product characterization, impurity control strategies, and stability studies.
Responsibilities
- Lead external activities for Aurinia’s commercial portfolio currently consisting of LUPKYNIS and other analytical method development activities
- Excellent analytical method development expertise, troubleshooting and identifying root causes for problems during the development of methods
- Deep understanding of dissolution parameters for release of the actives from softgel capsules, tablets, bilayer tablets, delayed release tablets etc
- Review of technical protocols for analytical methods and approve once the method is executed completely without any issues
- Technical transfer of analytical methods from one lab to another to other CDMOs
- Keep up with literature and adopt new technologies for analysis of small molecules and large molecules
- Cross-functional engagement of outsourced vendors (i.e. CDMOs/CROs), management and interdepartmental teams to assist in analytical method qualification and validation activities
- Coordinates/collaborates within CMC and interdepartmentally with R&D, RA, QA to support analytical method development activities
- Author and review analytical and stability study sections of regulatory filing and annual product review submissions
- Lead and support various elements of late-stage CMC development activities, such as risk assessments, product characterization, impurity control strategy, and method validations
- Analyze, interpret, present and document complex technical information such as analytical development data, testing trends in batch manufacturing, in support of CMC objectives
- Work with contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work
- Be a key contributor and reviewer of IND and other global regulatory filings
- Provide scientific direction to CDMO project teams to identify and enable qualification of analytical methods based on the stage of development
- Excellent organizational skills with a proven aptitude to communicate with colleagues and external collaborators in a fast-paced environment
- Ability to travel up to 25% of time to CMO/CTL sites periodically to collaborate on projects
- Other related duties as assigned
Skills
- Minimum of 10 years' industry experience in analytical method development, method validation, quality control supporting small molecules, large molecules in a matrix environment
- BS or MS in Organic Chemistry, Analytical Chemistry or related field
- Proven sales experience within the designated region with established and active relationships across the territory
- Displays a high-level of initiative, effort and commitment to ensure the completion of assignments and projects in a timely manner
- Strong attention to detail
- Excellent communication and people skills
- Sound judgment and problem-solving skills
- Collaborative approach with team in order to drive results
- Maintain a positive working relationship with key customers and external contact
- Ability to travel up to 25% of time to CMO/CTL sites periodically to collaborate on projects
- Ph.D in Analytical Chmistry prefered
Benefits
- This role may be eligible for discretionary bonuses and other incentive programs.
- Employer sponsored insurance plans including medical, dental and vision coverage
- Generous paid time off
- Retirement plan options
- Additional wellness and professional development programs
Company Overview