Analytical Development Leader (Sr. Director Level)

We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.

• Bill and Melinda Gates

The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biotech dedicated to accelerating the product development timeline for diseases that disproportionately affect the world’s poorest populations, including malaria, tuberculosis, and diarrheal diseases—diseases that combined cause five deaths every minute- and a range of challenges in maternal and newborn health. Headquartered in Cambridge, MA and led by CEO Emilio Emini, Ph.D. our focus is on advancing novel drug and vaccine candidates against the aforementioned diseases from the laboratory into human studies and beyond. At the Gates MRI, we work across multiple interventions and disease areas to increase the identification, selection, and optimization of novel drug and vaccine candidates, with the intention to develop viable candidates through late-stage development and registration both in house and with partners across the global health ecosystem. We will seek to publish our learnings, so that they will be available to all research and development communities through our commitment to open access.

The Five Core Mantras That Permeate Across The Organization And Drive Progress At Every Level Are

To enable a fast-to-decision mindset, the institute operates using small teams and a flat structure with the understanding that it is essential to break out of silos and embrace unconventional approaches across modalities.

• Urgency : Execute with excellence to maximize impact.
• Collaboration : Establish empowered teams to drive our bottom line: lives saved.
• Innovation : Build on the known, uncover the new, achieve the unprecedented.
• Rigor: Drive the science, focus on the details, and execute with the highest quality.
• Courage : Dare to confront the world’s most significant global health challenges.

Though the Institute is a diverse group of passionate change-makers, creative fixers and relentless advocates, these five core values will be universally adopted by all who join it and strive to improve the health and wellness of the world’s most vulnerable populations.

The Gates MRI offers flexible work arrangements for local candidates (50% on site) and a competitive relocation package for those looking to move to the Cambridge, MA area for this on-site role.

THE POSITION

Reporting to the Head of CMC, the Analytical Development Leader will be responsible for leading all analytical development activities across the Gates MRI portfolio of vaccine, drug and monoclonal antibodies product candidates at all stages of development from pre-clinical through Phase 3 and licensure. Working closely with our process/bioprocess development, clinical, quality and regulatory teams, s/he will develop/verify analytical control strategies (ACSs) for the Intermediates, Drug Substances and Drug Product for each product candidate. As all of the Gates MRI development work is conducted through contract organizations, the Analytical Development Leader will work with our external partners to ensure the identification, development, qualification and validation of robust analytical methods for characterization and release to support progression of our clinical programs and to enable late stage and commercial manufacturing by future partners. Responsibilities include analytical method development and qualification/validation, analytical support of process development, formulation and drug product development, reference standard selection and qualification, critical reagent sourcing and evaluation, product and impurities characterization, analytical testing review, OOS/OOT/deviation investigations, and stability studies. The Analytical Development Leader will engage with a diverse set of partners both internally and externally to meet program goals and to support the mission of the Gates MRI.

• Works with external partners on the development, qualification and validation of release, characterization and stability methods including biophysical, cell-based and in vivo assays
• Oversees release testing, characterization testing, stability and comparability studies using appropriate statistical tools for the analysis of analytical data
• Provides analytical support of process development, formulation and drug product development, including product and impurities characterization,
• Ensures reference standard selection and qualification, critical reagent sourcing and evaluation
• Leads analytical testing review and guides OOS/OOT/lab deviation investigations
• Contributes to enhanced process understanding and identification of key sources of variability and root causes of product and process failures
• Oversees development of/reviews technical documents such as product specifications, qualification and test protocols, assay transfer protocols, assay qualification and validation protocols and reports, technical reports, sampling plans, risk assessments, and/or relevant sections for regulatory submission files.
• Own and maintain the knowledge and history of method development and qualification throughout the method and product lifecycle
• Support change review and implementation, quality investigations, CAPAs in cross-functional teams
• Maintain proficiency in the latest analytical technologies as well as emerging analytical development strategies
• Builds network of analytical experts that can be accessed as needed to tackle challenges across the full Gates MRI portfolio.

Qualifications

• PhD degree in a relevant scientific discipline
• 10+ years of experience in the biotech or pharmaceutical industry with an emphasis on protein-based therapeutics/vaccines.
• Expertise in analytical method development, technology transfer, and validation
• Demonstrated knowledge of phase appropriate pharmaceutical analytical development (spanning R&D process, regulatory support, etc.)
• Experience in the establishment of GMP product specifications
• Experience in the design and management of IND-enabling stability
• Previous authorship of CMC sections of regulatory filings
• Strong understanding of cGMP, FDA and EMA guidance, ICH guidelines
• Experience building capability, both internally within own organization and externally with a range of partners
• Strong organizational skills
• Demonstrated excellence in scientific writing and date analysis, written and oral communication skills, and experience advocating and communicating with a broad and diverse audience.
• Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission.

The Gates MRI requires all employees based in the United States to provide proof of full vaccination against COVID-19, subject to applicable laws

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Hiring Requirements

As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

Depending upon your work location, we may require proof of full vaccination against COVID-19 and any recommended booster doses. All employees based in the United States are to provide proof of full vaccination upon hire and any recommended boosters, subject to applicable laws.

Accommodations

If you require assistance due to a disability in the application or recruitment process, please submit a request to [email protected] .

Inclusion Statement

We are dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.

All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.