Director of Technical Operations

CompanyCapstone, a fast-growing, private equity-owned pharmaceutical company; develops complex generic products, internally and for commercial partners, located in Rosemont, IL https://www.capstonedevservices.com/OverviewResponsible for supporting our commercial portfolio including supply chain and process optimization and innovation ensuring drugs are developed and manufactured on-time, within budget & scope.

Key Responsibilities· Support selection of contract manufacturing organization (CRO) with a team of Supply Chain, Quality and Regulatory personnel.· Manage contract analytical laboratory sites as required to support third party manufacturing relationships.· Guide external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to all manufacturing operations.· Work with Regulatory, QA and Senior Management to ensure that all company policies are adhered to, and all external manufacturing activities comply with relevant regulations.· Maintain knowledge of current best practices of pharmaceutical manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate.· Design and execute the development plan to support regulatory submissions.· Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required.· Provides comprehensive project analysis to senior management as required in the form of reports or presentations.· Effectively work with cross-functional team leaders to achieve company goals.· Ensure overall operational budget is within the approved budget and timeline. Qualifications· Bachelor of Science required; Master’s or PhD in a relevant discipline preferred· A minimum of 15 years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing in the biotechnology or pharmaceutical industry.· Experience in leading and direct management of research, process development, and manufacturing. Knowledge, Skills and Abilities:· Good understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas.· Knowledge of global CMC-related regulatory requirements and guidelines an advantage.· Excellent leadership, managerial and communications skills in a cross-functional environment.· Proficiency in analysis of scientific data and results with ability to review scientific. documents including reports, publications and regulatory submissions.· Prepared and managed the preparation of CMC regulatory filings.· Ideal candidates will possess demonstrated project management skills, as well as strong teamwork/interpersonal skills and a demonstrated ability to influence at many levels across many disciplines, both externally and internally. CompensationCompetitive health benefits, 401k plan, salary, annual incentive and upside equity opportunity Send resumes to: HR@capstonedevservices.com NOTE: Local candidates preferred