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Associate Director, Bioanalytics

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Feb 25, 2024

View more

Discipline
Science/R&D, Biotechnology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

The Role

Modernas Bioanalytics group is seeking an Associate Director with strong hands-on experience in ligand-binding assays, including pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody (ADA) assessments, to quantify mRNAs, proteins, and antibodies against therapeutic proteins. The primary responsibility will be to bolster our preclinical development efforts and assist in advancing the candidates to clinic.

The selected individual will lead a small team of 3 to 4 members and will 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.

Heres What Youll Do

  • Lead the ligand-binding assay team to support non-clinical studies and act as Subject Matter Expert for Ligand Binding Assays and support method validation as required.

  • Work closely with the Head of Bioanalytics to discuss the status of the different projects and their progress.

  • Aid in the method development and qualification of new ligand binding assays to support preclinical projects across Modernas therapeutic portfolio.

  • 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.

Heres What Youll Need (Minimum Qualifications)

  • Ph.D. in Chemistry, Biochemistry, Immunology, Analytical Sciences, or a related field, with at least 7 years experience

  • Experience in the biotechnology or pharmaceutical industry.

  • A minimum of 3-5 years 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.

Heres What Youll Bring to the Table (Preferred Qualifications)

  • Minimum of 5-10 years of hands-on experience in Bioanalytical Method Development, qualification, validation, and sample analysis to support GLP/nGLP studies.

  • 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, LCMS, Flow cytometry are 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
    Discretionary year-end 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

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

#LI-JW2

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
US

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