Sr. Director, Bioanalytics

The Role

Moderna’s Bioanalytics group is seeking a Sr. Director with strong hands-on experience in Mass Spectrometry, PCR and or Ligand Binding Assays as applicable to mRNA therapeutics to support pharmacokinetics (PK), and pharmacodynamics (PD), assessments of our Therapeutic Portfolio.  The primary responsibility will be to bolster our preclinical development efforts and assist in advancing the candidates to clinic.

The selected individual will lead multiple teams comprised of professionals supporting lipid, protein and mRNA quantitation, collaborate with various departments to determine assay requirements and deadlines, ensuring the success of our projects.

The ideal candidate must excel in a dynamic, high-expectation environment. Essential qualities for success in our team include integrity, a commitment to quality, problem-solving skills, creativity, inquisitiveness, a team-oriented mindset, respect for others, an outstanding work ethic, and the ambition to set and achieve high standards.

Here’s What You’ll Do

• Lead the LCMS, PCR and Ligand Binding teams to support non-clinical studies and act as Subject Matter Expert on bioanalytical assay development/qualification/validation requirements.

• Guide the team in the method development and qualification of new ligand binding assays to support preclinical projects across Moderna’s therapeutic portfolio.

• Work with other stakeholders engaged in nonclinical development and support programs from conception to FIH and beyond

• Able to critically review and efficiently troubleshoot any assay issues.

• Manage multiple experiments, projects, and interactions simultaneously.

• Coach and mentor members of the team

• Evaluate new and upcoming technologies/ platforms to lead innovation across the Bioanalytics team.

• Collaborate with the outsourcing function to facilitate the transfer, qualification, and validation of assays to Contract Research Organization (CRO) partners, as well as assist with troubleshooting any assay-related issues with these partners.

• Interface with preclinical project teams to understand their priorities as well as aid in the interpretation of data.

• Work closely with cross-functional groups to align on projects and priorities (direct or at subteam meetings).

• Implement processes to ensure timelines are met with data and documentation quality.

• Coordinate the need of critical reagents (drug products, purified recombinant proteins etc.) either from internal sources (CMC, Protein Sciences) or external sources (CROs, Vendors).

Here’s What You’ll Need (Minimum Qualifications)

• Ph.D. in Chemistry, Biochemistry, Immunology, Analytical Sciences, or a related field, with at least 11 years of experience in the biotechnology or pharmaceutical industry.

• A minimum of 5-10 years in a leading/managing staff members in a dynamic biotech organization

• Extensive expertise in Bioanalytical method development, qualification, validation to support nonclinical programs from conception to first in human.

• Demonstrated ability to lead cross-functional teams and work collaboratively in a matrixed environment.

• Exceptional communication skills, with the ability to articulate a clear vision and ability to coach team members.

• Proven track record of scientific publications and presentations, with a reputation as a thought leader in the field

• Strong project management, organization, and attention to detail; ability to handle multiple projects in a fast-paced environment.

• Willingness to learn new concepts and challenge boundaries; adaptability to change.

• Strong interpersonal skills with an eagerness to work with and support colleagues in other departments.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Minimum of 10 years of hands-on experience in Bioanalytical Method Development, qualification, validation, and sample analysis to support GLP/nGLP studies.

• Expertise in discovery and development of therapeutics using mass spectrometry

• Strong knowledge of Bioanalytical Assay Validation regulations (FDA, EMA guidance)

• Expertise in Ligand Binding Assay Methods (ELISA, MSD, Gyrolabs, Simoa etc.)

• Experienced with critical reagent characterization and life cycle management.

• Working knowledge of skills in PCR methods, is  highly desirable.

•  desire to make an impact as part of a high-growth, transformati