Sr. Manager, Chemical Development

Please note that this position can be based in Princeton NJ OR San Diego CA. Acadias hybrid model requires this role to work in our office an average of 3 days per week.

Position Summary:

Responsible for the chemical process development implementation and management of robust cost effective and safe processes for the manufacture of APIs from the research stage through clinical development and marketing approval. Will be responsible for the technical development support innovative solutions and commercialization of drug substances using an external network of providers. This position is integral to the advancement of ACADIAs growing portfolio of drug candidates and will provide technical oversight expertise and guidance of externalized drug substance development related activities.

Primary Responsibilities:

• Lead scientific strategy for drug substance development ensuring scalable efficient and compliant processes that meet clinical and commercial needs

• Oversee contract service providers (CSPs) to develop optimize and scale manufacturing processes from preclinical through commercialization

• Apply risk assessments and Quality by Design (QbD) principles to define design space and establish robust control strategies

• Develop end-to-end drug substance strategies supporting product quality global regulatory approvals and supply chain flexibility

• Manage technology transfer outsourcing and external manufacturing to build a reliable and scalable supply chain

• Establish evaluate and manage CSP partnerships including contract negotiation performance oversight and issue resolution
  

• Ensure cGMP compliance oversee deviations and change management and partner with Quality and Regulatory to assess impact on filings

• Lead planning and execution of timelines deliverables and CMC documentation to support regulatory submissions and inspections
  
  
• Provide cross-functional leadership and technical expertise supporting internal teams governance forums and external diligence activities

Education/Experience/Skills:

Ph.D. degree in Synthetic Organic Chemistry or other related scientific discipline. A minimum of 8 years of relevant progressive experience in API development and manufacturing in the pharmaceutical/biotechnology industry with a minimum of 5 years in a scientific role. An equivalent combination of relevant education and applicable job experience may be considered.

Requirements:

• Leadership experience in managing diverse project activities with contract CDMO facilities at different global locations

• Experience with global pharmaceutical/chemical development and manufacturing operations for development-stage small molecules including upstream/downstream process development. Well-versed in drug substance manufacturing control strategies

• Highly knowledgeable with FDA and ICH guidelines relating to registration quality and compliance with small molecule drug substance

• Awareness of scientific developments and opportunities in chemistry/chemical engineering

• Strong understanding of organic synthetic chemistry concepts and cross-functional understanding related to API development from pre-IND through NDA

• Chemistry Manufacturing Controls (CMC) expertise to prepare documents for regulatory filing (e.g. IND to NDA)

• Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs

• Excellent communication interpersonal and presentation to effectively collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)

• Skilled at negotiating with business partners/management and influencing senior level leaders regarding matters of significance to the problem-solving abilities and conflict resolution skills

• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.