Director, Drug Substance and Early Development
4 weeks ago
Want to see how your resume matches up to this job? A free trial of our JobsAI will help With over 2,000 biopharma executives loving it, we think you will too Try it now — JobsAI. Role Summary Director, Drug Substance and Early Development overseeing early development activities for the clinical-stage biologics pipeline, including monoclonal antibodies and fusion proteins. Responsible for advancing drug substance development strategy, formulation, cell line development, bioreactor scale-up and tech transfer to ensure robust, scalable, and compliant processes for clinical and future manufacturing. Remote work option available for US-based candidates. Responsibilities Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing. Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners. Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance. Drive formulation development strategies for early-phase programs, ensuring compatibility with downstream processing and stability requirements. Collaborate cross-functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams. Serve as a technical SME during tech transfer to CDMOs and during regulatory interactions. Author and review CMC sections of regulatory filings (IND/IMPD/BLA). Evaluate and implement new technologies to enhance upstream development capabilities. Qualifications PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or MS with 12+ years. Proven track record in upstream process development, cell line development, and bioreactor scale-up for biologics is highly preferred. Hands-on experience with monoclonal antibodies and/or Fc fusion proteins is required. Strong understanding of formulation development for early-phase biologics. Experience working with CDMOs and managing outsourced development/manufacturing activities. Familiarity with regulatory requirements for early- and late-stage biologics development. Excellent leadership, communication, and project management skills. #J-18808-Ljbffr
-
Waltham, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
-
Waltham, Massachusetts, United States Dyne Therapeutics Full time $217,280 - $266,750Company Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
-
Senior Director, Drug Substance Manufacturing
21 hours ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...
-
Associate Director, GMP Quality Assurance
1 week ago
Waltham, United States Kailera Therapeutics, Inc. Full timeAssociate Director, Gmp Quality Assurance (Drug Substance) At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to...
-
Associate Director, Drug Product
2 weeks ago
Waltham, United States Kailera Therapeutics Full timeAssociate Director, Drug ProductAt Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for...
-
Waltham, Massachusetts, United States Xilio Therapeutics Full time $163,000 - $190,000Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel,...
-
Waltham, United States GlaxoSmithKline Full timeA global biopharmaceutical company is seeking an Early Clinical Development Medical Director specializing in Oncology. You will lead clinical trials for innovative therapies in prostate cancer, collaborating closely with scientists and regulatory professionals. Ideal candidates hold a medical degree with oncology experience in clinical research. This...
-
Waltham, United States AstraZeneca Full timeThe AD Scientist isan important member of the Project Team, working under the supervision of aclinical lead/study physicianor senior clinical scientist, supporting activities related to the medical scientific aspects of the compound and its development. The accountabilities are broad; however, the core accountabilities are the medical & scientific support...
-
Waltham, MA, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - London, USA - Massachusetts - Waltham, Warsaw Posted Date: Nov 26 2025 GSK Oncology Early Clinical Development is seeking a highly skilled and motivated Early Clinical Development Medical Director- Oncology, to join our dynamic Oncology Research and Development team. In this role the...
-
Associate Director, Nonclinical Development
4 days ago
Waltham, MA, United States Ardelyx Full timeDescription Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for...
