Director, Product Champion (CMC-Team Lead)

Reports to: Senior Director, CMC

Location: Remote Work, US only

Position Summary: 

 The Director, Product Champion (CMC-Team Lead) leads the orderly progression of Sabin’s vaccine products from the clinical stage through process validation activities (PPQ) and ultimately commercial lifecycle management by interacting with the external manufacturing and development partners, internal Sabin technical and projects teams and external funders.

The role primarily involves matrix team leadership and integration of all CMC activities in conjunction with outside test labs and CDMO partners while ensuring compliance with regulatory standards and meeting objectives and requirements for internal and external funders and stakeholders. Additionally, responsibilities include supporting furthering cAd3-Marburg Vaccine and cAd3-Sudan development and commercialization activities, including compiling documentation needed for future funding initiatives. 

Responsibilities:

• Provide cross-functional matrix team leadership and end-to-end integration of CMC efforts for late-stage vaccine candidates.
• Provide project and portfolio leadership supporting IND-enabling early and late-stage biotech development CMC activities.
• 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.
• Coordinate efforts and facilitate communication to ensure alignment between Sabin and external partners.
• Actively communicate, manage, and mitigate risks to stakeholders.
• Overall accountability for successful Module 3 IND, BLA/MAA and associated regulatory submissions, including leadership of 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.
• Provide written and verbal updates and presentations to internal and external stakeholders.

• 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 12 years of direct experience with CMC product and process development
• Direct experience with CMC 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, and have a proven track record of working cross-functionally, across a wide variety of technical, business, and operational areas.
• 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
• Ability to work independently with minimal direct oversight
• Experience with validation and commercialization of late stage (Phase 3) biopharmaceutical products, including BLA/MAA authoring and defense
• Position may require up to 15% travel (USA and international)

Preferences:

• Experience with matrix team leadership
• Knowledge of adenoviral vector manufacturing, development, characterization and validation
• Strong statistical background

Other:

• Must demonstrate interest in furthering Sabin’s mission
• 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 starting annual salary for this position ranges from $165,000 - $195,000. The exact compensation may vary based on skills, experience, training, certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs. 

Sabin offers a competitive benefits package that includes Medical, Dental, Vision and Flexible Spending Accounts. Employer paid, Life and Disability insurance along with 11 paid holidays with a winter break between Christmas and New Years. Employer match on 401(k).

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.