Director, Small Molecule Chemical Development

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. 

COMPANY OVERVIEW:

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.

POSITION OVERVIEW:

As Disc Medicine evolves from a clinical stage to commercial stage organization, the Company has a new role for a Director of Small Molecule Chemical Development. The successful candidate will be instrumental in driving the company’s growth trajectory and achieving strategic objectives.

The Director of Small Molecule Chemical Development will be responsible for overseeing CDMO activities related to technology transfer, development, optimization, scale-up, development manufacture, and commercial manufacture of small molecule drug substances 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 chemical processes for small molecule drug substances in the pharmaceutical industry.

RESPONSIBILITIES:

• Oversight of 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 substance manufacturing
• As needed, providing on-site monitoring of drug substance manufacturing at contract sites, and support of deviations and investigations
• Writing and reviewing drug substance development reports based on contractor results, data and documentation
• Designing, developing, and optimizing “mutagenic impurity free” synthetic organic processes/procedures to prepare new small molecule drug substances at a CDMO
• 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, Medicinal Chemistry, Quality Assurance, Regulatory Affairs, and Project Management

 REQUIREMENTS:

• PhD in synthetic and/or mechanistic organic chemistry
• At least 10 years of experience with 7+ years in chemical process development of small molecules and in developing and optimizing chemical processes
• Able to design synthetic routes and complex procedures for defined compounds
• Analytical skills such as HPLC, GC, LC-MS, NMR, FTIR, KF, DSC
• Experienced writing reports on synthetic processes
• 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 and sources of commercial chemicals
• Experience with chemical scale-up, manufacturing batch record preparation, technology transfers, and knowledge of larger scale GMP chemical synthesis
• Hands-on experience with laboratory research and development, pilot plant scale-up and/or larger scale chemical synthesis is desirable
• Ability to manage multiple projects simultaneously and work independently under limited supervision
• Experience in IND and NDA filings is desirable
• Proficiency with word-processing, spreadsheet, chemical drawing, presentation, and statistical software (i.e. MS Word, Excel, PowerPoint, ChemDraw; experience with CASE Ultra, Derek Nexus, JMP, Design Expert, MiniTab, DynoChem, SAP, and/or MS Project is helpful.)
• 20-30% travel required

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. 

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.