Senior Manager, Quality CMC @Albert B Sabin Vaccine Institute Inc

[Hiring] Senior Manager, Quality CMC @Albert B Sabin Vaccine Institute Inc

Mar 28, 2025 - Albert B Sabin Vaccine Institute Inc is hiring a remote Senior Manager, Quality CMC. 💸 Salary: $115,000 - $145,000. 📍Location: USA.

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Role Description

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 term stability and Sabin disposition, while ensuring ongoing compliance with applicable regulatory standards.

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 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.

Qualifications

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.
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.

Requirements

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.

Benefits

Medical, Dental, Vision and Flexible Spending Accounts.
Employer paid Life and Disability insurance.
11 paid holidays with a winter break between Christmas and New Years.
Employer match on 401(k).

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📍	Be aware of the location restriction for this remote position: USA
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Senior Manager, Quality CMC @Albert B Sabin Vaccine Institute Inc

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Salary 💸 $115,000 - $145,000	Remote Location USA
Job Type full-time	Posted Mar 28, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Senior Manager, Quality CMC @Albert B Sabin Vaccine Institute Inc

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