Director of Small Molecule Chemical Development

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.
• 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.
• Ability 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.

Company & Location

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. The Company headquarters are in Watertown, MA, and they provide a flexible work environment.