Position Description

This position will be responsible for planning and execution of Drug Product CMC development and manufacturing, to support progression of clinical and preclinical candidates. This position will collaborate with Venatorx project team members, external consultants, and contract service providers on drug product development strategy, detailed planning, and execution.

Duties and responsibilities

Responsibilities include:

• Manage collaborations with contract service providers on development and manufacturing activities, including but not limited to preformulation, excipient selection, formulation prototyping, small scale manufacturing process development, process scale-up, and clinical manufacturing.
• Manage the procurement of raw materials and packaging components to contract service providers to support development and clinical manufacturing.
• Provide technical oversight of development activities at contract service providers. Review and interpret formulation and process development reports authored by contract service providers and ensure technical adequacy to support regulatory filings.
• Perform technical review of contract service provider pre-executed master batch records. Provide on-site coverage of technical batches and clinical batches. Participate in post-manufacturing technical activities, including batch record reviews and manufacturing investigations.
• Identify opportunities to optimize the manufacturing processes, focusing on manufacturing quality, process robustness and efficiency.
• Contribute to the authoring of CTD modules to support regulatory submissions (IND through NDA). Contribute to authoring of responses to questions from regulatory authorities.
• Contribute to the authoring of background packages to facilitate productive discussions with regulatory authorities.
• Develop and maintain a comprehensive understanding of regulatory guidance pertaining to drug product development and commercialization. 
• Collaborate with project teams to meet project objectives, budget, and timelines.

Qualifications

Candidate requirements:

• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely-related disciplines with 10 years of drug product development experience, or MS with 12 years of relevant drug product development experience or BS with 15 years of relevant drug product development experience.
• 10 years of drug product development experience in pharmaceutical/biotech industry.
• Experience successfully partnering with CDMOs on product development and clinical manufacturing.
• Experience in late phase development activities, e.g. manufacture of drug product supplies for pivotal clinical trials, registration stability studies, and process validation.
• Experience authoring New Drug Applications (NDA) and responding to CMC questions from FDA/international regulatory authorities.
• Experience in the development of products containing more than one active ingredient (i.e. fixed dose combinations).
• Knowledge of drug product CDMO landscape, ability to contribute to the identification and selection of CDMO partners.
• Experience developing parenteral formulations.
• Ability to apply sound scientific principles in the development of formulations and the processes used to produce them.
• Strong organizational and communication skills.
• Self-starter and a team player that will thrive in an entrepreneurial environment. 

This is a representative description of the job and is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.

Venatorx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law.

For more information, please check out our website: www.venatorx.com