Pharmaceutical Process Development Leader

“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. 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 Gates and Melinda French-Gates

The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute.  Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration.  The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions.  The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.

The Institute is based on five core “mantras” that are embedded within the organization and its people:

• 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 are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.

As a wholly owned subsidiary and separate legal entity of the Bill & Melinda Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.

The Institute is currently composed of 160 employees and leverages dedicated vendor partnerships and consultant staff to assure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.

Though the Gates MRI offers hybrid work arrangements, a 50% mix of on-site and work-from-home, remote work is not available for this key leadership role at this time.  A competitive relocation package for those looking to move to the Cambridge, MA area is available.  

THE POSITION

              The MRI’s focus is translation from discovery through late-stage development with a special emphasis on access and affordability of solutions to the poorest and most vulnerable. Reporting to the Head of CMC, the Pharmaceutical Process Development Leader will be responsible for leading the team that develops the manufacturing processes for products in the Gates MRI’s pharmaceutical pipeline.  This role will be responsible for the creation of and oversight of the process development strategies from candidate selection to First in Human studies.

This role will serve as a member of the CMC Leadership team, working in concert with the Head of CMC to influence organizational vision while translating a portfolio of programs into an executable strategy. The ability to set strategy collaboratively, anticipate, identify and mitigate risk, and pivot effectively in support of organizational goals will be important. This role will also be responsible to propose and manage program timelines, budgets, and resources effectively across assets to ensure projects stay on track and meet milestones. ensure a robust manufacturing process that is efficient, timely, and cost effective.

This role leads an experienced team that is responsible for a range of activities including developability assessment, API and Drug Product development, formulation development, manufacturing for pre-clinical and early to late-stage clinical studies and establishing a commercially viable process and product design. In addition, the team partners with the Gates MRI Discovery team in evaluating, from a CMC perspective, new products and new technologies that might contribute to the Gates MRI portfolio. The Pharmaceutical Process Development Leader must effectively manage and mentor the team guiding and supporting them to do their best work in the service of the goals of the Gates MRI. Demonstrated strong people leadership capabilities are essential to this role, and the Pharmaceutical Development Lead will be expected to communicate effectively, manage complexity and ensure accountability of the team.

The Gates MRI works in an outsourced model, so this role will also work with an expanded network of trusted partners and will manage activities through this network.  The ability to establish effective partner networks and maintain productive relationships will be a key part of the success of this role.  In addition, this role will provide leadership within the CMC organization and will partner with colleagues across the Gates MRI, including those in CMC, Quality, Regulatory, Clinical, Non-Clinical and Program Management, among others.  The Process Development leader should demonstrate strong collaboration skills, vendor management planning and management abilities as well as the ability to collaborate with others to achieve common goals.

Finally, with the Gates MRI’s goal of providing affordable solutions, innovation in manufacturing technology is essential. The Pharmaceutical Process Development Leader will be a change leader and key driver of innovative approaches and implementation. The role calls for an individual who combines strategic direction setting with the willingness to roll up their sleeves and address the issues of the day. The ability to make timely and sound decisions, often in complex or ambiguous situations, is crucial.

The Pharmaceutical Process Development Leader role:

• Serves as CMC program leader on small molecule Product Development Teams (PDTs) and is responsible for two-way communication between the CMC program team and the PDTs
• Builds and maintains a network of trusted development and manufacturing partners
• Develops and implements solutions for accelerated small molecule candidate transitions to first in human studies.  Is responsible for effective problem-solving as well as anticipation and prevention of issues
• Provides strategic direction, tactical oversight, and technical expertise to the team of process development scientists working on small molecule drug development activities consisting of formulation development, API & Drug Product process development, scale-up, tech transfer, pre-clinical and clinical manufacturing, and commercial scale development
• Oversees small molecule formulation and process development working with CDMO’s
• Responsible for tech transfer and managing API and Drug Product manufacturing through the CDMO network
• Directs small molecule commercial process development with a focus on developing a robust tech transfer package with emphasis on access and affordability
• Champions innovation and drives implementation thereof in small molecule manufacturing for Global Health
• Supports writing of CMC sections for regulatory filings

QUALIFICATIONS

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent
• 15+ years of relevant experience in small molecule drug development covering process chemistry, drug product development, scale-up, and tech transfer
• Experience with Fit-For-Purpose/Phase-appropriate development.
• Deep understanding of small molecule drug development and CMC’s contribution to developability as a critical component of the Discovery to Development transition
• Experience in CDMO/CMO management and oversight is essential
• A thoughtful and experienced people manager, able to guide and support team members to do their best work. High emotional intelligence and strong communication skills required
• Proven track record of strong collaboration with internal and external stakeholders. Demonstrated ability to influence others to achieve common goals.
• Willingness to be both a strategic leader and a hands-on problem solver. Experience in roles requiring ability to think strategically and develop plans to achieve long-term objectives as well as demonstrated problem-solving skills.
• Aligned with the GMRI’s mission, experience with transitioning of candidate molecules from discovery to early phase development is equally important as experience in late phase to commercial transitions.
• Ability to manage complexity to effectively solve problems.
• A proven ability to achieve increased manufacturing efficiency and manufacturing cost reduction through innovation, taking new and creative solutions, and putting them into practice
• Ability to handle and manage crises effectively
• cGMP experience
• Strong analytical and organizational skills

In recognition of high-wage market differences such as the Cambridge, MA area where this position is located, the salary range for this role is $400,000-$450,000 USD.   As a mission-driven organization, we strive to balance competitive pay with our mission.  New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate’s job-related skills, experience, and expertise, as evaluated during the interview process.

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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.

Candidate Accommodations

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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.