Delphia Therapeutics
Senior Director, CMC
About Us
Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first‑in‑class targeted cancer medicines that can provide better and more durable outcomes for patients, particularly where drug resistance is observed. Partnering together in a supportive, open, and collaborative environment, we share a sense of purpose, urgency and commitment to patients to approach cancer biology through a different perspective and to establish Activation Lethality as the next wave of oncology therapeutics.
What You’ll Do
Lead Delphia’s CMC function across the portfolio including development and oversight of drug product formulation, and management of external manufacturing partners (CDMOs), regulatory compliance (GMP, INDs, etc.), and cross‑functional teams to meet project timelines.
Provide technical leadership for all CMC‑related activities, including formulation development, process optimization, analytical method development, and stability studies.
Oversee technology transfer, scale‑up, and manufacturing operations at external contract development and manufacturing organizations (CDMOs) to support drug substance, drug product, and analytical services.
Build external partnerships and extended CMC team, including consultants, CROs and CDMOs to support projects across the portfolio.
Collaborate closely with the supply chain and clinical development teams to ensure the timely and accurate delivery of clinical trial materials.
Ensure all CMC activities adhere to global regulatory standards, including FDA, EMA, and ICH guidelines, and current Good Manufacturing Practices (GMP).
Collaborate with Quality Assurance to maintain high quality standards across all operations and partners.
Bridge internal team members and external partners through strong communication and collaboration to drive projects and meet team goals.
What You’ll Bring
Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline required.
10+ years pharmaceutical or biotech industry experience in CMC, including formulation optimization and drug product development.
Experience leading a program from pre‑IND to clinical development.
Experience with working with CDMOs and teams of consultants.
Experience with IND/BLA/MAA writing and review.
Strong technical/analytical skills to identify and solve problems.
Experience with small molecule formulations is required; lipid‑based formulations experience is a strong plus.
Working knowledge of FDA/ICH/EMA guidelines and cGMPs, phase‑appropriate development strategies across IND‑NDA stages and global requirements for IND and NDA submissions (or their regional equivalents) is highly preferred.
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partners.
Strong organizational skills in order to maintain a high level of productivity and innovation.
Ability to set priorities in order to complete assignments in a timely manner and within budget.
Ability to travel nationally/internationally to CDMOs/external partners.
The anticipated salary range for candidates for this role is $235,000–$270,000 at the Senior Director level. The final salary offered will depend on several factors, including, but not limited to, relevant years of experience and educational background.
Seniority level Director
Employment type Full‑time
Job function Research and Science
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What You’ll Do
Lead Delphia’s CMC function across the portfolio including development and oversight of drug product formulation, and management of external manufacturing partners (CDMOs), regulatory compliance (GMP, INDs, etc.), and cross‑functional teams to meet project timelines.
Provide technical leadership for all CMC‑related activities, including formulation development, process optimization, analytical method development, and stability studies.
Oversee technology transfer, scale‑up, and manufacturing operations at external contract development and manufacturing organizations (CDMOs) to support drug substance, drug product, and analytical services.
Build external partnerships and extended CMC team, including consultants, CROs and CDMOs to support projects across the portfolio.
Collaborate closely with the supply chain and clinical development teams to ensure the timely and accurate delivery of clinical trial materials.
Ensure all CMC activities adhere to global regulatory standards, including FDA, EMA, and ICH guidelines, and current Good Manufacturing Practices (GMP).
Collaborate with Quality Assurance to maintain high quality standards across all operations and partners.
Bridge internal team members and external partners through strong communication and collaboration to drive projects and meet team goals.
What You’ll Bring
Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline required.
10+ years pharmaceutical or biotech industry experience in CMC, including formulation optimization and drug product development.
Experience leading a program from pre‑IND to clinical development.
Experience with working with CDMOs and teams of consultants.
Experience with IND/BLA/MAA writing and review.
Strong technical/analytical skills to identify and solve problems.
Experience with small molecule formulations is required; lipid‑based formulations experience is a strong plus.
Working knowledge of FDA/ICH/EMA guidelines and cGMPs, phase‑appropriate development strategies across IND‑NDA stages and global requirements for IND and NDA submissions (or their regional equivalents) is highly preferred.
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partners.
Strong organizational skills in order to maintain a high level of productivity and innovation.
Ability to set priorities in order to complete assignments in a timely manner and within budget.
Ability to travel nationally/internationally to CDMOs/external partners.
The anticipated salary range for candidates for this role is $235,000–$270,000 at the Senior Director level. The final salary offered will depend on several factors, including, but not limited to, relevant years of experience and educational background.
Seniority level Director
Employment type Full‑time
Job function Research and Science
#J-18808-Ljbffr