Director, Bioanalytics - Cambridge, United States - Moderna

Moderna

Verified Company

Cambridge, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

The Role

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.

Here's What You'll Do

Lead the LCMS (discovery & development) and PCR teams to support non-clinical studies and act as Subject Matter Expert for LCMS focused programs and support method validation as required.

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.

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).

Mentor/coach staff members.

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

Ph.
D.

in Chemistry, Biochemistry, Immunology, Analytical Sciences, or a related field, with at least 10 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, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community

Generous paid time off, including:

Vacation, sick time and holidays
Volunteer time to participate within your community
D iscretionary yearend shutdown
Paid sabbatical after 5 years; every 3 years thereafter

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras

About Moderna
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