What are the responsibilities and job description for the Biologics CMC Lead position at Rhapsogen, Inc.?
Company Description:
Rhapsogen, Inc. is a biotechnology company based in Cambridge, MA, with a focus on developing precision biologics for IgG-mediated autoimmune diseases. Founded in 2025 by industry-leading scientists Professors Jeff Ravetch and Eric Sundberg, and backed by Catalio Capital Management, the company pioneers innovative solutions to address autoimmune conditions. Its best-in-class enzymatic approach selectively eliminates IgG Fc effector functions while retaining protective humoral immunity. With its unique, non-immunosuppressive mechanism, Rhapsogen’s groundbreaking therapies have the potential to transform the treatment landscape for IgG-driven autoimmune disorders. The company is also advancing early development programs targeting pathogenic autoantibodies.
Position Summary:
This role is accountable for developing the vision, strategy and implementation of drug substance and drug product CMC strategies for The Company’s portfolio programs and oversees matrix leaders who govern the success of technical development as a whole and work across the Company to define phase appropriate integrated control strategies. The role also oversees analytical and product technical development for process analytics, product testing, and investigations from method development to enabling assay validation.
This role collaborates with external partners and stakeholders across the entire organization to advance the Company’s product portfolio.
Responsibilities:
- Accountable for the execution of our overall CMC strategy for drug substance and drug product to advance the Company’s program goals, following the Company’s mission and in alignment with relevant GxP principles
- Manage our CMC activities at our CDMO partners to execute phase-appropriate technical development (process, analytical, MSAT, raw material qualification, etc.), and tech transfer.
- Provide guidance during authoring, approval, or review of study documents, batch records, protocols, and analyses as required in collaboration with Quality and Manufacturing teams to deliver clinical and commercial products
- Develop policies for risk mitigation across the CMC portfolio, and champion technical strategies or source novel technologies to meet CMC objectives
- Manage alliances at corporate, governance, or sub team levels, as needed
- Oversee and/or contribute to the development and review of regulatory submissions, as needed
- Oversee development of CMC playbook, and other policy documents
- Enable development and implementation of integrated analytical control strategies for drug substances and drug products
- Provide technical oversight for product or analytical investigations, as needed
- Oversee and/or contribute to the development and/or review of regulatory submissions, as required
- Mentor and facilitate individual development of team members.
Qualifications:
- Comprehensive knowledge of product development technologies, process development and validation strategy, analytical development, and validation strategy
- Demonstrated success in leading matrixed CMC teams
- Demonstrated experience and ability to successfully execute leadership responsibilities in a fast-paced environment, collaborating across the corporation and external partners are needed
- Demonstrated agility and leadership enabling phase appropriate drug development programs
- Demonstrated willingness and ability to develop and drive strategies and rolling up their sleeve to implement and operationalize strategies
- Strong experience with development and lifecycle management of investigational new product applications (IND)is required
- Demonstrated ability to develop strategy, perform long-term planning, team building, budgeting, and operational excellence
- Excellent verbal and written communication skills
- Excellent organizational skills and attention to detail
Education and Experience:
- Ph.D level in the life sciences with 10 years (director-level) of pharmaceutical or biotechnology industry experience
- Bachelor’s or Masters degree in Life Sciences or related field with 15 years (director-level) of pharmaceutical or biotechnology industry experience
- Experience in a CMC leadership role and/or leading a high-performing team in the DS/DP field. Minimum 5 years’ experience interacting and managing CDMO collaborations