Manager/Senior Manager, CMC (Drug Substance Downstream/Purification

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 Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary:

 The Senior Manager, Drug Substance CMC (Downstream/Purification) provides comprehensive technical support and expertise in Chemistry, Manufacturing, and Controls (CMC), particularly focusing on process development, characterization, manufacturing, and tech transfer of the downstream/purification portion of the Drug Substance process. The role primarily involves leadership of technical aspects of the downstream/purification process 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 and to support tech transfers to alternate manufacturers.

Responsibilities:

• Provide technical leadership of all aspects of downstream drug substance manufacturing and process development from bulk harvest to final drug substance manufacturing and process development
• Support process characterization and optimization efforts to support commercial control strategy development at partner CMOs
• Author technical reports and protocols
• Assist with the writing and reviewing documents for INDs / regulatory section submissions
• Prepare, review, or edit validation, CMC, Regulatory, and Quality documents such as risk assessments and E&L, microbial control, viral control, and process control strategy documents
• Perform statistical analysis of manufacturing process data, identification and investigation of adverse trends
• Lead technical investigation teams to identify root causes of process and analytical deviations
• Work closely with project managers at both Internal Sites and CDMOs to ensure project milestones are maintained
• Collect information and prepare documentation to support future funding efforts
• Identify program gaps and perform risk identification/mitigation and facilitate risk assessments to ensure timely execution of project deliverables
• Manage, create and review CMC and Quality Systems documentation as required
• Support tech transfers to other facilities 

•  Minimum bachelor’s degree in biochemistry, chemistry, biology, chemical engineering or related pharmaceutical science; advanced degree highly desired
• Minimum of 7+ years of direct experience with CMC aspects of biopharmaceutical manufacturing and development with significant focus on downstream unit operations including lysis, depth filtration, chromatography, ultrafiltration/diafiltration, bioburden reduction filtration and freezing
• Direct experience and training in current good manufacturing practices (cGMP)
• Working knowledge of ICH guidelines and associated regional requirements (FDA, EMEA, MHRA and similar)
• Non-conformance investigation and root cause analysis
• Corrective/preventive action implementation
• Demonstrated ability to work in a collaborative matrix team environment across multiple technical functions and geographical regions
• Ability to work independently with minimal direct oversight
• Up to 15% travel to support tech transfer and start up activities

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
• Process validation execution experience
• Experience with viral clearance studies
• Shipping validation execution experience

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 $105,000 - $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.