Idera’s CMC Technical Operations Lead is an opportunity for a dynamic, experienced, and highly collaborative individual to lead and develop CMC and related technical operations capabilities for Idera’s strategic and highly promising Ph2/3 oligonucleotide-based asset targeting PD-1 resistant melanoma and potentially other cancers. Scope of responsibilities for this critical role include drug substance manufacturing, formulation/process development, drug product manufacture, supply of clinical trial materials, and building the commercial supply chain. Ability to also manage CMC regulatory strategy development/execution and regulatory submission management for late-stage (phase 3, registration, post-approval) programs and based on U.S. and International requirements is desirable. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, collaborative entrepreneurial environment with broad responsibilities and opportunities. S/he will also embrace, espouse, and foster Idera’s core values of Caring, Courage, Excellence, Unity, and Passion.
Overall responsibility for all drug substance and drug product activities related to preclinical development activities, provision of clinical supplies for Phase 1 through Phase 3 registration studies, and commercial manufacturing of solid and injectable dosage forms.
Contract Manufacturing / Vendor Management:
· Identification, selection and oversight of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs.
· Partner with Quality Assurance to manage existing CMO partners and identify, assess and qualify new partners as needed.
· Facilitate technology transfer of new and existing API, DP and finished goods manufacturing among Idera’s CMO partners. livery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile.
· Project API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team).
· Via direct report, oversee management of supply chain and logistics in support of clinical studies.
Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
Cross-Functional Product Management:
· Manage regulatory CMC strategy and submission aspects for development programs.
· Work transparently in partnership with cross-functional product team to establish/communicate goals, timelines, and issues. Leverage cross-functional team in issue resolution as appropriate.
· Lead/participate in meetings with internal stakeholders and external business partners or teams for clinical development programs or collaborations to communicate regulatory CMC guidance and strategies.
· Provide critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications.
· Develop and implement strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs.
· Collaborate with Quality Assurance to manage programs and partners ensuring regulatory compliance during product development, validation, and commercialization.
· When required, review or author and approve deviation and investigation reports, change controls, and corrective/preventative actions (CAPA).
· Ensure that all CMO partners are using systems and processes in compliance with Idera specifications and relevant regulatory standards
· Ensure the content of CMC regulatory submissions are of high quality, consistent, complete, and comply with current regulatory standards.
· Work with Development functional experts to provide timely responses to CMC regulatory questions from global health authorities.
· Liaise with FDA and other health authorities as needed (e.g. telephone contacts, submissions). Lead regulatory CMC-related health authority meetings for assigned projects. Prepare summaries of meetings and contacts for inclusion in the regulatory archives. elop and update function specific SOPs and Work Instructions to ensure continuity, compliance and process improvement.
· Maintain current knowledge of relevant US and international guidance and regulations that affect CMC pharmaceutical drug development.
· Build and maintain a high performing functional team, and contribute to high performing cross-functional teams, in accordance with company values. Set and manage to team member performance expectations and develop team members’ skills and capabilities.
· Establish and manage to CMC/DP-related budget.
· Provide launch planning support and commercial scale estimates for new products.
· Contribute to CMC-related due diligence activities as needed.