About the position
Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. As Disc Medicine evolves from a clinical stage to commercial stage organization, the Company has a new role for a Director/Sr. Director of Small Molecule Product Development. The successful candidate will be instrumental in driving the company's growth trajectory and achieving strategic objectives. The Director/Sr. Director of Small Molecule Chemical Development will be responsible for working on CDMO activities related to technology transfer, development, optimization, scale-up, development manufacture, and commercial manufacture of small molecule drug products and related materials. There will be a significant contribution expected from this role to enable regulatory filings of Disc Medicine assets. This position requires a minimum of 10 years of industry experience developing drug products for small molecule drug substances in the pharmaceutical industry.
Responsibilities
- Working on CDMO activities related to technology transfer, development, optimization, scale-up, development manufacture, and commercial manufacture of small molecule drug substance and related materials
- Reviewing, verifying and approving process documentation and batch records for cGMP small molecule drug product manufacturing
- Providing on-site monitoring of drug product manufacturing at contract sites, and support of deviations and investigations as needed
- Writing drug product development reports based on contractor results, data and documentation
- Helping ensure compliance with cGMP requirements for drug product manufacturing activities
- Developing, characterizing, and troubleshooting drug product manufacturing process and unit operations
- Directing isolation and identification of impurities at a CDMO and recommending process modification to control impurity levels
- Regularly reporting work status and preparing presentations for team meetings
- Cooperatively working with CMC teams and personnel from other departments such as Analytical Development, Formulation Development, Quality Assurance, Regulatory Affairs, and Project Management
Requirements
- BS degree in pharmacy, chemical engineering, or pharmaceutics
- At least 10 years of experience in the development and manufacturing of drug products from pre-clinical through commercial
- Able to design drug product manufacturing processes
- Understanding of drug product analysis needs
- Experienced in writing reports on formulation and drug product process development
- Strong technical documentation writing skills in English
- Team player with ability to convey complex ideas with team members
- Knowledge and understanding of cGMP regulations and ICH guidance
- Knowledge and understanding of the GMP CDMO industry
- Experience with drug product manufacturing scale-up, manufacturing batch record preparation, technology transfers, and knowledge of larger scale GMP product manufacture
- Hands-on experience with laboratory research and development
- Ability to manage multiple projects simultaneously and work independently under limited supervision
- Experienced in IND and NDA filings, and drafting sections of eCTD module 3
- Experience with program management is a plus
- Proficiency with word-processing, spreadsheet, presentation, and statistical software (i.e. MS Word, Excel, PowerPoint, SAP, and Smartsheets is helpful)
Benefits
- Comprehensive benefits
- Competitive compensation packages
- Flexible work environment
