Insmed is seeking a talented individual to lead the Pharmaceutical Development group. The objectives of this role are to lead tech transfer activities from drug discovery to development, design and optimize formulations, make prototype dosage forms, optimize processes, select and work with CMOs, oversee scale-up activities, oversee analytical method development, write regulatory documents, and contribute to the overall pharmaceutical development activities – from pre-formulation to clinical drug product manufacturing – in multiple projects.
- Managing the technology transfer from research to development.
- Manage and oversee analytical method development in support of drug development.
- Working with manufacturing team to transfer process for GMP manufacture
- Design and develop robust, scalable formulations, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities.
- Evaluate and select contract service providers (CSPs), conduct tech transfer, plan and oversee activities, collaborate on the manufacturing and testing of drug product.
- Prepare and review formulation and product development reports.
- Support regulatory submissions by drafting and reviewing drug product sections of INDs, NDAs and IMPDs, and ensure compliance with current regulatory requirements.
- Represent the department at CMC and project meetings and work closely with cross-functional teams (Manufacturing, Quality Assurance, and Regulatory Affairs) to meet project timelines and goals.
- Manage and operate various instruments used in formulation development and analytical testing and carryout pre-formulation activities as needed for the projects.
- Keep abreast of latest developments in drug product manufacturing and testing technologies, cGMP requirements, regulatory guidance, and drug delivery approaches to drive new product development and lifecycle management.
- Demonstrated experience with development of drug-device combination products and proven working knowledge of design history files and current CFR requirements for combinations products a plus.
- Experience in robust product development and implementation of QbD principles.
- Ability to develop product development plan for use as a guidance during the development of the target product.
- MS in Chemistry or Pharmaceutical Sciences or a closely related science, paired with a minimum of seven (7) years working experience in a technical product development function is needed. Additional practical experience may compensate for a lesser scientific degree;
- Significant management experience of at least three (3) years is desirable
- Experience with the CMC development associated with combination products and drug delivery devices a plus
- Demonstrated ability to organize and lead teams
- Set priorities, establish team goals and plan activities to deliver the strategy for the defined program(s)
- Experience in selecting and managing CMOs for drug product development and testing.
- Experience in cGMP and drug product IND/NDA/IMPD regulatory filings.
- Deep experience with the CMC development and regulatory pathway
- Must have excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Ability to work independently, take initiative, lead and complete tasks to deadlines.
- Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.