Senior CMC Scientist

Job Posting Organization:
The organization is the largest nonprofit dedicated to fighting poverty, disease, and inequity globally. Founded on the principle that all individuals should have the opportunity to lead healthy and productive lives, the organization emphasizes diversity among its employees to reflect the populations it serves. It offers a comprehensive benefits package, including medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, retirement contributions, and opportunities for employee engagement. The organization is committed to fostering a supportive work environment that promotes both personal and professional growth.

Job Overview:
The position of Senior CMC Scientist involves developing and implementing Chemistry, Manufacturing & Controls (CMC) solutions to support product development, particularly in the context of vaccines. The role requires collaboration with various teams, including program strategy teams, grantees, and partners, to provide strategic and technical guidance on CMC issues. The focus is on products related to polio and other vaccines, ensuring safe and effective delivery options to support polio eradication efforts. The Senior CMC Scientist will contribute to the implementation and impact measurement of Bioprocess Research & Development and CMC solutions, assisting in the management of high-impact product development grants and identifying innovative technologies and partners. This role is crucial in integrating product development plans across teams and translating new knowledge into effective interventions.

Duties and Responsibilities:
The Senior CMC Scientist will be responsible for a wide range of duties, including:

• Contributing to the implementation, delivery, and impact measurement of Bioprocess Research & Development and CMC solutions aligned with strategic objectives.
• Managing a portfolio of product development grants to meet targets for cost, quality, safety, and therapeutic effectiveness.
• Identifying innovative technologies and partners, developing strategic objectives, and guiding project plans and timelines.
• Enabling integration of product development plans across teams and translating knowledge into interventions.
• Collaborating with product development partners to incorporate critical technical activities for program progression.
• Building a network of subject matter experts in CMC product development.
• Communicating CMC strategies to internal and external partners.
• Playing a strategic role in regulatory interactions and submissions.
• Partnering with the director" style="border-bottom: 1px dotted #007bff !important;">Deputy Director and other team members to implement technical solutions for vaccine candidates. 1
• Synthesizing commercial and technical information to inform strategic decisions. 1
• Managing grant proposals and providing analyses and recommendations for funding. 1
• Consulting with grantees to achieve desired impacts and conducting site visits as necessary. 1
• Managing internal processes and ensuring documentation and reporting are accurate. 1
• Preparing briefs and synthesizing literature for foundation management. 1
• Ensuring collaboration with stakeholders and timely communication of progress.

Required Qualifications:
Candidates must possess a Ph.D. degree or equivalent experience in biochemical engineering, biology, biochemistry, or a related field, with at least ten years of relevant experience. They should have experience in implementing CMC solutions for biologics, particularly vaccines, and a comprehensive understanding of all phases of vaccine product development, including late-stage experience. Familiarity with technology transfer, good manufacturing practices, and quality systems is essential, along with experience in product development for emerging markets. Candidates should also have a working knowledge of critical CMC activities and regulatory requirements for drug development.

Educational Background:
A Ph.D. degree in a relevant field such as biochemical engineering, biology, or biochemistry is required. Equivalent demonstrated experience may also be considered.

Experience:
The position requires at least ten years of experience in the relevant fields, with a strong emphasis on late-stage vaccine product development and CMC solutions. Candidates should have a proven track record in managing complex projects and collaborating with diverse teams.

Languages:
While specific language requirements are not mentioned, proficiency in English is mandatory due to the nature of the role and the need for effective communication with internal and external partners.

Additional Notes:
The salary range for this role is between $186,400 to $288,800 USD, with higher ranges for positions based in Seattle and Washington D.C. The organization recognizes market differences and aims to balance competitive pay with its mission. New hires typically fall within the range minimum and midpoint, depending on their skills and experience. Employment is contingent upon successful completion of a background check, and the organization is committed to diversity and inclusion in its hiring practices.