Manager/Senior Manager, Drug Product CMC (Chemistry, Manufacturing and Controls)

Reports to: Senior Director, CMC

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, Drug Product CMC provides comprehensive technical support and expertise in Chemistry, Manufacturing, and Controls (CMC), particularly focusing on the tech transfer and onboarding of new drug product and associated long-term storage and labeling facilities in the United States.
 

The role primarily involves leadership of site selection, tech transfer to GMP manufacturing and overseeing various aspects of production and process development 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 Vaccine development and commercialization activities, including compiling documentation needed for future funding initiatives. 

Responsibilities:

• Support tech transfer and onboarding of new US-based Drug Product site for one or more biopharmaceutical vaccines
• Support day-to-day management and oversight of new US-based Drug Product site
• Provide technical leadership in aseptic drug product manufacturing and process development
• Review, data verification and authoring support for vaccine candidate INDs and associated regulatory submissions
• Support Drug Product process characterization activities for late-stage vaccine candidates
• Collect information and prepare documentation as assigned to support future funding efforts
• Manage, create and review CMC and Quality Systems documentation as required
• Develop compliant validation and commercialization strategies for Drug Products
• Develop and lead implementation of contingency plans to ensure robust Drug Product supply chain in the USA
• Support on-boarding and day-to-day management of new third-party storage, logistics and pack and label CDMO(s) in the USA

• Minimum bachelor’s degree in chemical or pharmaceutical engineering, chemistry, biochemistry, analytical chemistry, or a related engineering or pharmaceutical science field. Advanced degree preferred.
• Minimum of 7 years of direct experience with CMC aspects of biopharmaceutical manufacturing and development, including substantial recent experience in Drug Product manufacturing and process development
• Direct experience with CMC aspects of biopharmaceutical manufacturing and development
• Candidates may be considered with a broad range of relevant CMC experience; however, substantial recent experience in Drug Product manufacturing and process development is required.
• Direct experience and training in current good manufacturing practices (cGMP)
• Working knowledge of ICH guidelines and associated regional requirements (FDA, EMEA, MHRA and similar)
• Working knowledge of Annex 1 and similar regional requirements and guidelines for sterile products manufactured with aseptic techniques
• Non-conformance investigation and root cause analysis
• Corrective/preventive action implementation
• Demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions
• Ability to work independently with minimal direct oversight
• Position may require up to 25% travel, primarily within the USA, to support start-up, oversight and person-in-plant duties at identified CDMOs.

Preferences:

• Experience with management of CDMOs and tech transfer
• Experience with regulatory agency interactions and/or responses to information requests
• Knowledge of adenoviral vector manufacturing processes or process development
• Strong statistical background, including six sigma principles and tools, SPC, and DoE methodologies
• Knowledge of packaging and labeling technology and requirements
• Experience with process validation and shipping validation strategy development and execution
•  Experience with commercialization of late stage (Phase 3) biopharmaceutical products, including Drug Product process characterization and BLA/MAA authoring and defense

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 $95,000 - $140,000. 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.