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Position Summary:

Senior Director leads the Chemical Development organization at ACADIA. 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 ACADIA’s growing portfolio of drug candidates, and will provide technical oversight, expertise and guidance of externalized drug substance development related activities.

The scope of the role encompasses a wide breadth of life-cycle, ranging from early stage development, late stage development, process validation, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role will be critical in ensuring we optimize development, reduced risk profiles and ultimately accelerate the development cycle of assets.

Primary Responsibilities:

  • Provides strong scientific leadership to the overall chemical development team to ensure that the development plan provides for rapid and innovative process development and scale-up of drug substance incorporating quality, safety, compliance, cost effectiveness, sustainability and reliability to meet development and commercial requirements
  • Oversee contract development organizations to lead the development and optimization of drug substance processes to support the program from pre-clinical phase through marketing approval
  • Formulate drug substance development strategy to ensure product quality, facilitate regulatory approvals globally and achieve operational flexibility of supply chain
  • Facilitate technology transfer, chemical outsourcing, external manufacturing to deliver a robust supply chain for all drug substances
  • Foster an inclusive workplace, creating staff development opportunities, encouraging innovation, advocating a quality culture, maintaining safety and achieving high performance
  • Engage in all facets of development from small scale synthesis to the development of the commercial synthetic route
  • Develop and implement strategic and operational plans to deliver drug substance for multiple development projects to challenging timelines
  • Initiates, evaluates and validates new drug substance CSPs to support commercialization scale-up
  • Establishes and maintains good working relationships with contract service providers
  • Negotiate and manage contracts and agreements
  • Works with CSPs to diagnose and correct process issues
  • Works with Quality Group to determine the impact of process deviations and works towards resolutions
  • Develops timelines, goals, and deliverables for drug substances and related manufacturing processes
  • Optimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs
  • Ensure supply of drug substance is consistent with development plans by coordinating drug substance production in multiple CSP sites, managing contracts and invoices
  • Ensures CSPs remain current and compliant with all cGMP related requirements, guidelines and procedures
  • Tracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings
  • Initiates and coordinates the preparation of CMC documentation
  • Collaborates with Regulatory Affairs and other groups to support product filings
  • Assists in contract site preparation activities for pre-approval inspections
  • Supports interdisciplinary working teams with recommendations, advice and action plans for drug substance-related issues
  • Evaluates new process technology ensuring freedom to operate and expanding the IP for the company
  • Provide onsite process coverage during process validation or as needed to resolve process issues
  • Communicates drug substance related issues and information to committees, teams and interested groups within the company
  • Supervise, train and mentor personnel
  • Supports corporate development activities, serving as drug substance/chemistry expert, as part of cross-functional diligence teams to assess external assets/opportunities

Education/Experience/Skills:

Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline. A minimum of 15 years progressively responsible experience in API development in the pharmaceutical/biotechnology industry with a minimum of 10 years in a leadership role. An equivalent combination of relevant education and applicable job experience may be considered.

Must possess:

  • 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
  • Well versed in FDA and ICH guidelines relating to registration, quality and compliance concerning small molecule drug substance
  • Contemporary awareness of scientific developments and opportunities in chemistry/chemical engineering
  • Is a highly credible technical functional expert with a strong understanding of organic synthetic chemistry concepts. Cross-functional understanding related to API development from pre-IND through NDA
  • Chemistry Manufacturing Controls (CMC) expertise required to prepare documents for regulatory filing
  • Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs
  • Excellent organizational and leadership skills; excellent communication, interpersonal and presentation skills
  • Exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
  • Strong business acumen including business contracting expertise
  • Skilled at negotiating with business partners/management and influencing senior level leaders regarding matters of significance to the organization
  • Demonstrated 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

Scope:

Establishes strategic plans for designated function(s) and participate with senior management to align objectives across the organization.  Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.  Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long-term success of the company.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Domestic and Overseas Travel is required.

 

 

ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

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