Job Type

Full-time

Description

Reports to: Senior Director, CMC Product Champion

Location: Remote Work, US only

Position Summary:

The Senior Manager, Chemistry, Manufacturing & Controls (CMC) Technical Operations supports the orderly progression of Sabin's vaccine products from the clinical stage through validation, ultimately to marketing authorization and commercial lifecycle management. This individual will work support the CMC Product Champion and work across the CMC functions to implement vaccine development strategies and support actualization across Sabin's network of external manufacturing and development partners.

The role requires matrix team support and broad technical expertise. This individual will ensure alignment and integration of CMC deliverables with vaccine development strategies, integrated product development plans, Sabin R&D stakeholders, and external funders with support from the broader CMC team.

Primary responsibilities include furthering development and commercialization activities for Sabin's cAd3-Marburg and cAd3-Sudan Vaccines, including compiling documentation needed for future funding initiatives. In the future, the end-to-end support of additional vaccines assets may fall under this role.

Responsibilities:

• Serve as cross-functional matrix team member and support end-to-end integration of CMC efforts for vaccine candidates
• Collaborate with internal and external CMC functional areas to ensure successful execution of assigned CMC projects, and delivery of results on time and within budget
• Assist with development and manufacturing alliance management, product development and manufacturing strategy
• Provide expert technical guidance across all CMC elements (banking through drug product, including testing and release), both internally and externally, to ensure appropriate product and process development
• Facilitate communication to ensure alignment between Sabin and external partners
• Proactively identify and communicate programs risks and work with teams to mitigate as required. Support stakeholder communication and alignment
• Support authoring, review and data verification of Module 3 IND, BLA/MAA and associated regulatory submissions, including Information Request responses
• Collect information and prepare documentation as assigned to support future funding efforts
• Manage, create and review CMC and Quality Systems documentation as required
• Support the implementation and administration of Sabin governance and management systems (including resourcing, financial planning/analysis, and similar)
• Provide written and verbal updates and presentations to internal and external stakeholders

Requirements

• Minimum bachelor's degree in biochemical engineering, analytical chemistry, pharmaceutical sciences, biochemistry, or a related engineering or pharmaceutical science field. Advanced degree highly desired
• Minimum of 10+ years of direct experience with CMC product and process development
• Direct experience with CMC biotechnology product and process development
• Working knowledge of all CMC areas including cell line development and characterization, drug substance, drug product, formulation development, packaging and labeling, and analytics, including stability programs and specification setting and justification
• Working knowledge and understanding of current regulations and industry trends for vaccine/biotechnology product development, manufacture, and testing
• Strong and effective project management, problem solving and interpersonal skills
• Strong writing and presentation skills
• Direct experience and training in current good manufacturing practices (cGMP)
• Working knowledge of ICH guidelines and associated regional requirements (FDA, EMEA, MHRA and similar)
• Demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions and lead in a matrix environment
• Ability to work independently with minimal direct oversight
• Position may require up to 15% travel (USA and international) with notice
• Must demonstrate interest in furthering Sabin's mission

Preferences:

• Experience with matrix team leadership
• Experience with validation and commercialization of late stage (Phase 3) biopharmaceutical products, including BLA/MAA authoring and defense
• Knowledge of adenoviral vector manufacturing, development, characterization and validation

Other:

• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees

Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $135,000 - $165,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

Salary Description

135,000 - 165,000