Manager/Senior Manager, CMC Analytical Sciences

Reports to: Director, CMC Analytical Sciences

Location: Remote Work

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary:

 The Manager/Senior Manager, CMC Analytical Sciences provides technical support and expertise in Chemistry, Manufacturing, and Controls (CMC) analytics and method development, particularly in the development and qualification of new methods, validation and transfer of existing methods, and stability program support. The role primarily involves supervision of CMC analytical activities in conjunction with outside test labs and contract development and manufacturing (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 Marburg Vaccine (cAd3-Marburg) and Sudan Virus Vaccine (cAd3-Sudan) development and commercialization activities, including compiling documentation needed for future funding initiatives. 

Responsibilities:

• Management and oversight of method development, qualification, verification, validation and transfer activities at outside testing labs and CDMOs providing testing services
• Technical support and troubleshooting of analytical methods
• Analytical data compilation and analysis
• Reviewing, data verification, and authoring support for analytical and stability sections of vaccine candidate regulatory submissions
• Support stability programs, including data analysis
• Management of samples and standards

• Minimum bachelor’s degree in analytical chemistry, pharmaceutical sciences, biochemistry, or a related engineering or pharmaceutical science field. Advanced degree highly desired.
• Minimum of 7 years of direct experience with CMC analytical development. Minimum of 5 years of direct experience with method validation and transfer
• Hands-on analytical method development experience
• SME-level experience in any of the following: HPLC/UHPLC, titer methods, ELISA impurity methods, cell-based methods, potency methods, infectivity methods, compendial methods, excipient quantitation, RT-PCR, laser light scattering.
• Method qualification, verification, and/or validation experience
• Method transfer experience
• Knowledge of current good manufacturing practices (cGMP)
• Experience in corrective/preventive action implementation
• Ability to troubleshoot methods remotely
• Successful experience in a collaborative team environment across multiple technical functions and geographical regions
• Strong technical communication and organizational skills
• Ability to work independently with minimal direct oversight and also collaboratively with globally distributed team members
• Ability to work remotely and travel up to 20% (USA and international) to support onsite activities at outside test labs (OTLs) and CDMOs

Preferences:

• Knowledge of adenoviral vector manufacturing and testing methods
• Experience interacting with CDMOs and OTLs
• Working knowledge of statistical approaches; use of JMP for data analysis and/or experimental design
• Cross-functional knowledge of other CMC disciplines, such as Quality Control, formulation development, sample management, stability, cell line development, cell culture, purification, process development, and/or drug substance or drug product manufacturing
• Familiarity with regulatory and compendial expectations (e.g., ICH, USP/Ph. Eur..) for analytical methods

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 $120,000 - $165,000. 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.