Senior Manager, Quality CMC (Chemistry, Manufacturing, and Controls)

Reports to: Director, Quality Assurance

Location: Remote Work

Position Summary:

The Senior Manager, Quality (CMC) provides comprehensive technical support and expertise in Chemistry, Manufacturing, and Controls (CMC) for the quality unit, particularly focusing on the transfer and onboarding of new aseptic finish/fill drug product sites in the United States. The role involves overseeing various aspects of production, drug substance and drug product manufacturing including oversight of CDMO quality systems, in-process and release testing, long tern stability and Sabin disposition, while ensuring ongoing compliance with applicable regulatory standards. Additionally, responsibilities include supporting the Marburg virus (MARV) and Ebola Sudan virus (SUDV) Vaccine drug development activities, outbreak response, ongoing internal quality system build out and promoting a quality culture within the organization.

Responsibilities:

• Quality lead and support for all technical transfer and onboarding of new US-based drug product Fill/Finish site(s) for drug product.
• Provide quality leadership in area(s) of expertise to potentially to include cell line development, cell culture, purification, formulation development, analytical development and characterization, drug substance manufacturing and final drug product manufacturing
• Ongoing assessment and evaluation of GXP service providers to ensure regulatory compliance. Departmental lead for monitoring testing and inspection of materials and products by contract service providers to ensure identity, strength, purity and quality is maintained
• Participate in internal and external audits/ inspections including other quality assurance assigned activities
• Assist in development and implementation of quality systems to identify, initiate and monitor corrective and preventive actions to support developmental and regulatory activities
• Manage, create and review CMC SOP’s and documentation as required
• Other duties as assigned

• Bachelor’s degree in a scientific field; master’s degree a plus
• 9+ years relevant experience, preferably in GXP quality assurance/quality control roles and with broad CMC drug substance/drug product, analytical/bioanalytical method exposure, quality system development and quality incident management
• Biologics product experience: strong knowledge of vaccine development preferred (Candidates may be considered with a broad range of Quality R&D and CMC experience to include cell line development, cell culture, purification, analytical development and characterization, formulation development, drug substance and drug product manufacturing)
• Demonstrated computerized systems competence, including experience with databases, electronic quality management systems and Microsoft Office
• Advanced problem-solving abilities and decision-making skills
• Excellent communication skills, including strong writing abilities
• Strong interpersonal skills; excellent at building productive working relationships with R&D team members and external collaborators
• Experience in project execution using virtual platforms (e.g., Zoom/MS Teams)
• Strong attention to detail, ability to manage complex tasks; highly organized, flexible, dependable and able to prioritize competing demands in order to meet deadlines
• Thrive in entrepreneurial, team-oriented work environments; experience working with cross-functional teams
• Ability to travel domestically and internationally as demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions
• Ability to work independently with minimal direct oversight

Preferences:

• Experience working in a quality role with CDMOs in the technical transfer/qualification process representing the quality team
• Exposure and experience with regulatory agency interactions and/or responses to information requests
• Knowledge of modern vaccine manufacturing processes or process development for drug substance/drug product manufacture
• Strong statistical background, including six sigma principles and tools, SPC, and DoE methodologies
• Quality oversight of process, analytical method, and shipping qualification/validation experience to ensure regulatory compliance.

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 $115,000 - $145,000. 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.