Your Opportunity:
Walden Biosciences’ mission is to transform the treatment of kidney disease by reversing its progression and enabling and inspiring patients to resume their normal lives. Our focus is on developing first-in-class, highly targeted therapies for individuals living with kidney disease. As a member of the Walden Team, you will have an opportunity to help us bring this mission to life.
Reporting to the Chief Scientific Officer, the Head of CMC, will lead, define, implement, and manage the CMC strategy for the company, including overseeing and managing relationships and deliverables from CDMOs for protein, as well as small molecule-based product formats. The successful candidate will demonstrate a depth of experience and leadership in CMC. We are seeking a highly collaborative individual with the ability to manage and oversee technology transfer, process development, supply chain (both non-GMP and GMP) supporting clinical through commercial, and distribution of material as required. This role will prepare documents for Regulatory approval and collaborate with clinical operations team to ascertain demand and supply schedules and manage supply to pharmacies for clinical trials. This includes Drug Substance, Drug Product, Storage, packaging/labeling, and distribution. This position is located in Cambridge, MA.
Responsibilities:
Define the CMC regulatory strategy for all portfolio programs, assuring IND/NDA approaches, anticipating, and managing issues, identifying regulatory success criteria, and implementing risk mitigation measures
Lead all CMC activities including the identification, management, and delivery of all CMC regulatory milestones, including global investigational drug filings, registrational filings, response to health authority questions, and Regulatory Agency meetings
As Regulatory CMC Product Lead you will provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the company’s portfolio of products, including different formats
Lead CMC related interactions with the health authorities including managing preparation of briefing documents
Keep abreast of global CMC regulatory requirements and keep the company informed of changes and consequences
Serve as primary regulatory contact and provide direction to CROs and contract vendors as needed
Develop and manage sourcing strategy and the evaluation and selection of vendors including for fill/finish/packaging operations
Support transition to commercial operations with drug product qualification runs, shipping validation and so forth
Partner with Global Supply Chain to support commercial supply chain while minimizing risk and optimizing cycle times and investment in inventory
Interact with Process, Analytical and Formulation development functions for the determination of DP release specification
Qualifications:
Bachelor’s degree (BA/BS) in a scientific discipline recommended and advanced degree preferred with a minimum of 10+ years’ experience in drug development/regulatory affairs
Strong technical understanding of CMC activities for biologics and antibodies, including upstream and downstream process development, formulation, and manufacturing, as well as direct experience with filing multiple INDs
Previous experience building a CMC function from the ground up preferred
Extensive knowledge of all technical aspects of IND-enabling CMC activities
Strong familiarity with current CMC regulatory guidelines in the US, with strong preference for familiarity with regulatory guidelines in a variety of settings and territories.
Experience with CMO selection, initialization and oversight of activities required
Proven ability to manage and direct multiple projects/teams simultaneously with excellent team working abilities and adjust to changing priorities
Chemistry, Manufacturing, and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions
Detailed knowledge of complex worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development
Proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy
Proven track record of successfully influencing and negotiating issues at a senior level within your organization and with regulatory agencies in a variety of settings
Proven track record of managing and directing multiple projects/teams simultaneously with excellent team working abilities and adjust to changing priorities
Highly motivated with experience of direct line management and proven ability to manage and direct multiple projects/matrix teams
Strong verbal and written communication skills with good attention to detail
Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives
Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects
Experience of recent regulatory submissions for different types of products and routes of administration
Experience of being involved in/leading business critical initiatives within and external to the organization
Experience with both US FDA and EMA is required. Global experience is preferred
Prior BLA and NDA experience is preferred
Experience with the regulation of biologics is essential; experience with other drug formats is preferred
Demonstrated ability to independently review CMC related documents and reports
Proven experience in critically reviewing detailed CMC-related scientific information and providing assessment of technical arguments and conclusions based on the data
About Walden Biosciences:
Walden Biosciences is a private, venture-backed biopharmaceutical company focused on developing breakthrough medicines to reverse the progression of both rare and common forms of kidney disease. Founded by world-renowned renal experts, the Company is applying a novel, multi-disciplinary approach that directly targets the kidneys to prevent damage and restore kidney function. Walden has active programs that address two novel targets for therapeutic intervention: soluble urokinase plasminogen activating receptor (suPAR) and dynamin. Targeting both suPAR and dynamin may be beneficial across numerous types of renal disease. Walden was launched in late 2020 with a $51 million Series A round of financing led by Arch Venture Partners with participation from other leading venture capital firms. For more information, please visit www.waldenbiosciences.com.