Senior Manager, CMC Technical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the seamless transition of Sabin vaccine products from the clinical phase through validation, marketing authorization, and commercial lifecycle management.

• Aid the CMC Product Champion in coordinating efforts across CMC functions as well as with external manufacturing and development partners.

• Act as a member of a cross-functional matrix team, integrating CMC initiatives for vaccine candidates.

• Partner with both internal and external CMC functional areas to ensure project execution and timely results within budget constraints.

• Support the management of development and manufacturing alliances along with product development and manufacturing strategies.

• Offer technical expertise across CMC components from banking through drug product, including testing and release processes.

• Enhance communication and alignment between Sabin and external collaborators.

• Recognize program risks, communicate them effectively, and collaborate with teams on mitigation strategies.

• Facilitate stakeholder communication and ensure alignment.

• Draft, review, and validate data for Module 3 IND, BLA/MAA, and related regulatory submissions, including responses to information requests.

• Gather information and prepare documentation for future funding initiatives.

• Oversee, create, and evaluate CMC and Quality Systems documentation.

• Support Sabin's governance and management systems, encompassing resourcing and financial planning/analysis.

• Provide written and verbal updates, as well as presentations, to both internal and external stakeholders.

• Advance development and commercialization efforts for Sabin’s cAd3-Marburg and cAd3-Sudan vaccines.

⛳️ Requirements

• A minimum of a bachelor’s degree in biochemical engineering, analytical chemistry, pharmaceutical sciences, biochemistry, or a related engineering or pharmaceutical science discipline.

• An advanced degree is highly preferred.

• At least 10+ years of direct experience in CMC product and process development.

• Hands-on experience with CMC biotechnology product and process development.

• Proficient knowledge in cell line development and characterization, drug substance, drug product, formulation development, packaging and labeling, analytics, stability programs, and specification setting and justification.

• Familiarity with current regulations and industry trends pertaining to vaccine/biotechnology product development, manufacturing, and testing.

• Exceptional project management, problem-solving, and interpersonal skills.

• Strong writing and presentation abilities.

• Direct experience and training in current good manufacturing practices (cGMP).

• Knowledge of ICH guidelines and regional requirements, including those from FDA, EMEA, and MHRA.

• Capability to work collaboratively across multiple technical functions and geographical regions while leading in a matrix environment.

• Ability to work independently with minimal oversight.

• The role may necessitate up to 15% travel within the USA and internationally.

• Must exhibit a commitment to advancing Sabin’s mission.

• Subject to a criminal background check.

• Three professional references are required.

• Education and degree verification is mandatory.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Flexible spending accounts.

• Flexible vacation leave.

• Sick leave.

• Options for short-term disability.

• Options for long-term disability.

• 10 federal holidays.

• A winter break at the end of the year.

• Employer-matching 401(k) plan.