Associate Director - Senior Director, Pharmaceutical Development

Apertor Pharmaceuticals, Inc., based in Alameda, CA, is creating novel molecular glues for therapeutic applications in oncology. Apertor’s compounds, called Interceptors, are heterobifunctional (HBF) therapeutics targeting disease-causing protein complexes.

Role:

We are seeking a skilled Associate Director, Director or Sr. Director of Pharmaceutical Development to manage pharmaceutical development across our heterobifunctional drug development programs. Reporting to the CEO, you will implement and oversee CMC development and manufacturing activities. You will also manage a network of consultants and Contract Development and Manufacturing Organization (CDMOs) partners to enable our efforts to develop heterobifunctional therapeutics.

We strongly encourage you to apply, even if you feel you don’t meet every qualification listed. Many strong candidates may not meet every single requirement. We urge you not to rule yourself out and to apply if you're interested in this opportunity.

Responsibilities:

• Lead pharmaceutical development, including dosage form selection, formulation development, process optimization, and scale-up activities, ensuring robust, cost-effective, and scalable manufacturing processes to support GMP drug product development. Direct CMC and cross functional project teams to ensure on-time supply of drug to support non-GLP toxicology studies, IND-enabling activities, and clinical trials.
• Design and execute CMC strategies, including defining control strategies and specifications for raw materials, drug substance, and drug product, to meet project development targets, ensure timely delivery of high-quality products, and facilitate regulatory approvals.
• Write and review CMC sections of regulatory documents and submissions and the supporting technical documents and remain current on Health Authority guidance and expectations.

Preferred Education and Experience:

• A BS, MS, or PhD degree in pharmaceutics, pharmaceutical sciences, chemical, or a related field along with a minimum of 10+ years of relevant industry experience with demonstrated increasing responsibilities within pharmaceutical development.
  
• Demonstrated ability to deliver CMC activities ranging from non-GLP and IND-enabling material supplies, through GMP clinical trial supplies.
• Expertise in small molecule formulation development, including delivery, scale-up and manufacturing, and phase appropriate control strategy and specification development.
• Knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations.
• Proven ability to manage and collaborate with external partners, including consultants and CDMOs.
• Demonstrated strong organizational and problem-solving abilities.
• Able to travel domestically and internationally as needed, up to 20% of the time