Senior/Scientist, Process Development (Downstream)

Q32 BIO is advancing novel therapeutics to treat serious autoimmune and inflammatory disorders. We aim to deliver life-changing treatments for patients with a variety of diseases for whom no adequate treatment options exist.

Our dynamic, industry-experienced team is growing. The CMC team is seeking a highly motivated, independent Process Development Scientist or Senior Scientist with expertise in purification and supply chain who desires to be part of an energetic, fast-paced and collaborative team. The immediate focus is to continue to drive our two programs: moving one lead drug candidate through enhanced process development towards later-stage manufacturing, including building out of supply chain capabilities, and moving another lead drug candidate through cell line development, bulk drug substance manufacturing, drug product fill/finish and IND filing.

The successful candidate will work closely with the Senior Director of CMC to implement our downstream process development and external manufacturing strategy through various stages of development. The Process Development Scientist will collaborate with external manufacturing partners in the technical and operational support of clinical production of bulk drug substance, drug product, and clinical trial material at CDMOs. In particular, he/she will interface with tech transfer teams regarding new product introduction, process change management, and qualification and/or validation activities. The Process Development Scientist will ensure the execution and timely release of clinical trial material and facilitate an environment of continuous improvement and operational excellence with our external manufacturing partners. Expertise in supply chain management of clinical trial material would be preferred. This role may support the research group to help improve process development and manufacturing understanding within Q32 as we further develop our pipeline.

RESPONSIBILITIES:

• Implement process development and external manufacturing strategy through various stages of development
• Coordinate purification process development of antibody-based drug candidates
• Oversee outsourced bulk drug substance CMC functions including cell culture, scale-up manufacturing, protein purification, analytical assay development, and release and stability testing
• Oversee outsourced drug product CMC functions including process development, analytical development and qualification, formulation, and supply chain management
• Assist in preparation of CMC regulatory documents
• Review and execute CMC project plans and timelines to ensure key goals are achieved
• Assist due diligence efforts, audits and site visits
• Serve as person-in-plant (PIP) and represent Q32 for outsourced bulk drug substance and drug product manufacturing campaigns
• Interface with external quality and regulatory consultants and support Q32's rigorous quality and regulatory systems and standards
• Design and execute lean internal experiments to quickly drive downstream process knowledge
• Effectively tech transfer process information to CDMOs and proactively manage vendor relationships
• Prevent and resolve operational issues e.g. deviations, corrective and preventive actions, production delays etc.;
• Effectively work within cross-functional teams to achieve corporate and program goals
• Lead the generation of SOPs, protocols, and reports for process development and manufacturing activities
• Understand and efficiently communicate project status and risks, present data and strategy
• Identify and promote opportunities to further streamline process development and manufacturing activities across relevant interfaces
• Assist in the incorporation of knowledge of current regulations, guidance and competitive environment into company culture

REQUIREMENTS/QUALIFICATIONS:

• BS/MS/PhD in chemical/biological engineering or similar field
• 5+ years relevant industry experience
• Understanding of quality assurance and quality control cGMP production requirements
• Experience transitioning preclinical research programs into IND enabling studies and clinical development
• Ability to support optimization of manufacturing processes and oversee manufacturing campaigns to generate materials enabling GLP toxicology studies and clinical trials
• Experience developing purification processes and managing supply chain of clinical trial material
• Ability to work in interdisciplinary teams
• Experience in project and budget execution
• Experience in a cross-functional, fast-paced environment
• Understanding of regulatory requirements related to pharmaceutical development, manufacturing and specifications
• Ability to travel up to 20% of time

DAY TO DAY:

• Weekly meetings with CDMO vendors, data review with CDMO vendors, batch record review with CDMO vendors (20-25%)
• Small-scale experiments to support CDMO vendors or move-along later phase development (20-25%)
• CMC administration duties - shipping, paperwork routing, Q32 reports, filing (15-20%)
• Authoring and/or reviewing stability materials, technical development reports, regulatory filing documents (20-25%)
• Person-In-Plant responsibilities, audit responsibilities (as needed)