Director Chemical Development
Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.
The Director in the Chemical Development organization at Acadia takes charge of 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.
- Provides strong scientific support to the overall chemical development team to ensure that the development plan provides for rapid and innovative process development and scale-up of drug substances incorporating quality, safety, compliance, cost-effectiveness, sustainability, and reliability to meet development and commercial requirements
- Lead contract development organizations to lead the development and optimization of drug substance processes to support the program from the pre-clinical phase through marketing approval
- Performs risk assessments of manufacturing process scale-up and use Quality by Design (QbD) principles to define the design space and develop an overall control strategy.
- 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 dedication
- 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 (Contract Service Providers) 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 the supply of drug substances is consistent with development plans by coordinating drug substance production in multiple CSP sites, managing contracts, and invoices
- Ensures CSPs remain current and aligned with all cGMP-related requirements, guidelines, and procedures
- Supervises deviations and processes changes for the different suppliers and collaborates with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings
- Initiates and coordinates the preparation of CMC documentation
- Works in tandem 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 as opportunities arise
- Supports corporate development activities, serving as drug substance/chemistry expert, as part of cross-functional diligence teams to assess external assets/opportunities
- PhD in synthetic organic chemistry with a minimum of 10 years of dynamic experience in pharmaceutical research, development, and manufacturing in the biotechnology or pharmaceutical industry, with at least 5 years of demonstrated ability in a leadership role in the areas of process development, process characterization, process validation and product life cycle management or BS/MS with equivalent experience is required.
- 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. Fluent in drug substance manufacturing control strategies
- Well versed in FDA and ICH guidelines relating to registration, quality and compliance concerning small molecule drug substance
- Awareness of modern 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 (e.g. IND to NDA)
- 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 leadership skills to collaborate with and advise the work of others on assigned projects (including both internal teams and external collaborators)
- Strong business sense 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
- Must reside in the United States
- Employee must be fully vaccinated against Covid-19 in accordance with our policy
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. Employee must be fully vaccinated against Covid-19 in accordance with our policy and in order to meet any independent vaccination requirements that our clients and client facilities may have.
What we offer you:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.