Manager/Associate Director, Pharmaceutical Development

Nanocan Therapeutics Corporation is an early-stage biotechnology company developing novel drug-delivery nanotechnology for more precise and targeted treatment of cancer and respiratory diseases. More precise local treatment can unlock local immune-driven potential and significantly reduce the risk of side effects. Through our partnerships with leading academic research institutions, we are rapidly developing new shorter and efficient combination therapies to help improve the lives of patients and improve global access to care. Please visit www.nanocan.life for more information.

Job Description:

Nanocan is seeking a Manager/Associate Director for Pharmaceutical Development. The candidate will support formulation development work while working closely with Contract and Development Manufacturing Organizations (CDMOs). The candidate will be responsible for drug product development and the GMP manufacture of therapeutic candidates from preclinical development through clinical development, and must be skilled in areas such as CMC documentation, product development, and analytical method development. Additionally, the candidate will be responsible for identifying, contracting and managing external vendors, as well as providing oversight of the outsourced activities while operating in the virtual environment.

Primary Responsibilities:

• Design and develop formulations and manufacturing processes to support clinical trials.
• Plan project-related scientific and technical activities, e.g. interpret results, evaluate data, formulate relevant and scientifically based conclusions, write and present technical reports.
• Prepare pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring, review and approval of requisite sections of the IND or other filings.
• Ensure appropriate technical, scale-up, and production strategies and timelines are in place to meet the clinical supply, and ensures technology transfer, validation and regulatory outcomes are met.
• Manage external vendors, such as Contract Research Organizations (CROs), CDMOs and Contract Manufacturing organizations (CMOs) throughout product development life cycle.
• Adhere to cGMP work practices and work closely with the Company’s Quality organization to ensure strict compliance with applicable GXP procedures and compliance requirements.
• Manage product and raw material specifications and product shelf-life/stability protocols.
• Author and review formulation development reports and drug product sections for IND filings.

Education/Experience/Skills:

Bachelor’s degree in Pharmaceutical Sciences or a related field. MS or Ph.D. highly preferred. Equivalent combination of relevant education and applicable job experience may be considered.

A minimum of 3 years progressively responsible experience in pharmaceutical development with a focus on dosage forms development. Demonstrated ability to write technical and or scientific documents. Demonstrated success in the field of formulations with exposure to combination products, modified release and injectable dosage forms is preferred.

Must Possess:

• Comprehensive understanding of the dosage formulation development process.
• Comprehensive understanding of the dosage form manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs and past experience in development of IND.
• Skilled at managing CROs and CMOs. 
• Drug-Device Combination Product Experience
• Ability to inspire and energize others through expert technical knowledge, personal leadership, influence, and thorough planning and drive for timely and appropriate results.
• Flexibility to travel.
• Broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies.
• Must have outstanding communication and collaboration skills within cross-functional team and external organizations.

Application Instructions:

To apply, please email your resume and cover letter to jwalker@nanocan.life.

Nanocan is an equal opportunity employer. Nanocan will not discriminate, or tolerate discrimination, on the basis of race, creed, sex, color, national origin/ancestry, gender, age, religion, genetic information, physical or mental disability, pregnancy, marital status, military or veteran status, sexual orientation, expression or identity, political activity, criminal accusation, domestic violence victim status, use of a service animal, use of tobacco products, citizenship status, or any other characteristic protected by federal, state, or local law. Nanocan’s policy and practice are to recruit, hire, assign, advance, compensate, develop, train, and retain applicants and/or employees solely on the basis of qualifications and contributions to our business, and all employment decisions will be administered in a nondiscriminatory manner.