Director/Senior Director, Analytical Development

Orna Therapeutics • Watertown, MA

95d • $186,760 - $291,305

About The Position

We’re looking for an exceptional Director/Senior Director (commensurate with experience), Analytical Development to join our Process Development and Analytical Sciences (PDAS) team to lead analytical method development activities for Orna’s oRNA-based lipid nanoparticle therapeutics from research to clinic. The ideal candidate will have analytical development expertise with biologic, mRNA/oRNA and/or gene therapy and provide leadership in developing strong analytical portfolio for Orna pipeline candidates. The incumbent will work closely with R&D, Process development, Manufacturing and Quality control to develop novel release and characterization methods. This role will manage the transfer of methods to contract labs or contract manufacturing organizations for GMP testing of drug substance, drug product and novel lipids. They will author relevant CMC sections and supporting documents for regulatory filings. The role will also manage all aspects of internal analytical lab to ensure reliable analytical testing is performed, including the management of methods, SOPs, protocols and method development reports. We are looking for enthusiastic, detail-oriented, highly motivated talent with a passion for bringing novel medicines to patients and who are comfortable working in a fast-paced scientific team.

Requirements

• Strong oral and written communication capabilities; demonstrate excellent collaboration & interpersonal skills; and be adept at problem solving in a fast-paced environment
• Be familiar and close enough to details of the science, programs, and day-to-day activities to be able to anticipate any potential program risks and issues
• Strong leadership skills, including demonstrated ability to work with a cross-functional team, and to influence at all levels of an organization
• Develop effective and efficient working relationships with both internal and external partners -available to travel if/when needed
• Strong analytical and problem-solving skills are necessary along with great attention to detail
• Excellent oral and written communication skills, including presentation to effectively communicate key updates/challenges to the program team
• Detail oriented, self-motivated, and excited to take on new challenges
• PhD in Analytical Chemistry, Biochemistry, Biology, or related field with 10+years of industry experience or MS with 15+ years of industry experience
• Prior experience with mRNA/oRNA and/or liposome/LNP formulation related analytical testing is required
• Good understanding of analytical method transfers and regulatory requirements for RNA-LNP modalities
• In-depth understanding of various analytical techniques including UPLC/HPLC, LC-MS, DLS, Sequencing, ELISA, qPCR, Western blot, SDS PAGE, particle size and compendial test methods is required
• Adept in development, qualification, validation, and transfer of analytical methods in a GMP environment to support process development, product characterization, clinical material release, stability studies, and other pharmaceutical development and analytical studies
• Ability to lead a team of Scientists to develop comprehensive analytical understanding of oRNA pipeline products in pre-clinical and clinical development
• Working knowledge of cGMP regulations, global guidance documents for testing of DS, DS and novel excipients, preparation of analytical technical documents and regulatory filings
• Experience in developing release testing, characterization testing, product and process impurities characterization and specification development
• Experience leading complex, multi-disciplinary projects and teams during biotech drug development

Responsibilities

• Lead, manage and develop the analytical development team
• Responsible for the development of analytical methods that robustly test and characterize our oRNA-based lipid nanoparticle platform products, management of testing multiple programs
• Build and develop analytical understanding to support robust clinical supply of our platform products
• Design, execute and document analytical method development in support of process development, product release, stability and product characterization of oRNA-LNP platform products. Work cross-functionally to develop phase-appropriate specifications for DS, DP and novel lipids
• Maintain awareness of current industry trends and practices for design, development and optimization of analytical methodologies for testing and characterization of oRNA DS, DP, novel excipients
• Establish and manage appropriate laboratory controls for sample management, data integrity, reagents, and equipment
• Draft, review and approve method development and qualification reports
• Work with internal and external laboratories to assure robust method development, transfer, and execution in GMP and GLP settings
• Author, review and approve – IND/IMPD sections; participate in scientific advice preparations and meetings
• Lead and develop Analytical Development team members and advocate for the group through participation in internal and external forums and continuously improve the team’s performance
• Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture

Benefits

• This position will be eligible for an annual target bonus percentage and equity based on job level, generous time off policies, and a comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees