Director/Senior Director, Drug Product

Director/Senior Director, Drug Product

Boston, MA (Hybrid) Full-time

About Us

Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for new disease-modifying treatments. With multiple programs with best-in-class potential on track to enter clinical development in 2026, our goal is to rapidly bring forward optimized treatments with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes.

This is a unique opportunity to join a science-driven company at a formative stage, where early clinical data will directly shape development strategy and drive long-term value. The right candidate will join a team with significant early- and late-stage development experience, with the goal of quickly moving through dose escalation/expansion into pivotal trials.

The Role

The

Director/Senior Director, Drug Product

will report to the SVP, Technical Operations and will be responsible for leading formulation and process development, technical transfer, and manufacturing of drug product (monoclonal antibodies) into vial and/or prefilled syringes (PFS). This individual will lead phase-appropriate development efforts including optimization, characterization, validation, technical transfer, and routine manufacturing of drug product processes at Contract Development Manufacturing Organizations (CDMOs). This role will be a key contributor within Technical Operations at Damora. The successful candidate will be a confident process specialist with a proven track record in managing and leading biologic (monoclonal) programs through development and in support of licensure and commercialization.

What You'll Do

• Lead the drug product development strategy and execution enabling consistent, high-yielding, high-purity, and scalable processes for vials and prefilled syringes (PFS).
• Develop robust, scalable formulations and drug product manufacturing processes to produce clinical trial material (CTM) while ensuring product quality
• Oversee technical activities at drug product CDMOs including technology transfer, CTM production, process troubleshooting, QbD and PAR studies, risk assessments, registration batch production, and process validation
• Responsible for technical leadership in technical issue resolution with CDMO partners, including formulation challenges, technical transfer, design of experiments, and interpretation of results
• Provide technical and scientific direction to CDMOs and external laboratories to ensure project deadlines and performance standards are met
• Lead the development/optimization of scalable, efficient, and cost-effective processes; lead the design of experiments incorporating Quality by Design (QbD) into the process characterization
• Lead process validation activities and strategies including establishing and evaluating process characterization plans, overseeing execution at CDMO, reviewing and approving CDMO reports
• Oversee the preparation of manufacturing batch records, technical reports, data summaries and CMC related documents required for various regulatory submissions
• Coordinate with Quality and Supply Chain teams to ensure timely manufacture and release of drug product lots by leading technical reviews of batch records, deviations, change controls, and nonconformance investigations; proactively identify and mitigate risks related to clinical supply
• Manage related SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices
• Serve as the drug product subject matter expert for program teams, due diligence activities, and CMO selection, management, and audits
• Ensure adherence to applicable regulations and guidelines, including FDA, EMA, ICH, GCP, and GMP
• Provide person-in-plant support for drug product manufacturing
• Author and review CMC sections of regulatory filings, including INDs, IMPD/IND amendments, and NDA/MAA submissions

What You'll Bring

• Masters or PhD (preferred) in engineering, chemistry, biological science, or another relevant field
• 12 years of relevant biopharmaceutical industry experience with experience in process development, technical transfer, and implementation of biologics (monoclonal antibodies preferred) for subcutaneous administration
• Expertise in process design and development approaches with a thorough understanding of regulatory requirements for both vials and syringes
• Knowledge of needle safety devices, autoinjectors, and on-body devices preferred.
• Demonstrated ability to successfully work with and influence CDMOs while maintaining a positive working relationship
• Proven leadership in developing and optimizing formulations and processes, scaling them up for implementation, and transferring them to CDMOs
• Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
• Hands-on, roll-up-your-sleeves approach with strong drive for results
• Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
• Ability to think outside of the box and challenge the status quo
• Natural entrepreneurial spirit with unrelenting dedication to delivering results
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team

Environment

• Hybrid in the Boston area
• Dynamic, interactive, fast-paced and entrepreneurial environment
• May require up to 20% travel

Compensation \& Benefits

At Damora Therapeutics, we offer competitive compensation and thoughtfully designed total rewards aligned with industry benchmarks. We believe in rewarding impact and building meaningful ownership for our team.

Agency Policy

We are building our team intentionally and do not accept unsolicited resumes from recruiting or staffing agencies. Agencies should not submit candidates unless directly engaged by Damora’s HR team and operating under a signed agreement. Any resume submitted without prior authorization and a signed agreement will be considered property of Damora Therapeutics, and no referral or placement fees will be paid.