Senior Director Chemical Development
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The Senior Director in the Chemical Development organization at Acadia is responsible for the chemical process development, implementation, and management of robust, efficient, and safe processes for the APIs from the research stage, through clinical development and marketing approval. This person will oversee technical development, support, and innovative solutions for the production 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 mentorship of externalized drug substance development-related activities.
- Provide 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 substance incorporating quality, safety, compliance, cost-effectiveness, sustainability, and reliability to meet development and commercial requirements.
- Oversee contract development organizations driving the development and optimization of drug substance processes to support the program from the pre-clinical phase through marketing approval.
- Perform risk assessments of manufacturing process scale-up and use Quality by Design (QbD) principles to define the design space and develop overall control strategy.
- Formulate drug substance development strategy to ensure product quality, facilitate regulatory approvals and achieve operational flexibility of supply chain.
- Facilitate technology transfer, chemical outsourcing, external manufacturing to deliver a robust supply chain for all drug substances.
- Engage in all facets of development and create small-scale synthesis to the development of the commercial synthetic route.
- Develop and implement strategic and operational plans to deliver drug substances for multiple development projects with crucial timelines.
- Initiate, evaluate and validate new drug substance CSPs (Contract Service Providers) to support commercialization scale-ups.
- Negotiate and lead supplier contracts and agreements.
- Work with CSPs to diagnose and troubleshoot process issues.
- Work with Quality Group to resolve the impact of process deviations and work towards resolutions.
- Develop timelines, goals, and deliverables for drug substances and related manufacturing processes.
- Optimize the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce production costs.
- Ensure the supply of drug substance is consistent with development plans by coordinating drug substance production in multiple CSP sites, leading contracts and invoices.
- Track deviations and process changes from the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
- Coordinate the preparation of CMC documentation to support manufacturing and regulatory filings.
- Assist in contract site preparation activities for pre-approval inspections.
- Support interdisciplinary working teams with recommendations, advice and action plans for drug substance-related activities and issues.
- Evaluate 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.
- Supervise, train, and mentor personnel as opportunities become available.
- Support corporate development activities, serving as drug substance/chemistry authority, as part of cross-functional diligence teams to assess external assets or in-licensing opportunities.
- A PhD degree in synthetic organic chemistry with around demonstrated ability in pharmaceutical research, development and manufacturing in the biotechnology or pharmaceutical industry.
- BS/MS degree with equivalent experience is required and could be considered with shown experience.
- Desired 10 years’ experience in a leadership role in the areas of process development, process characterization, process validation, and product life cycle management
- Leadership experience in running 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 experience in drug substance manufacturing control strategies, FDA and ICH guidelines relating to registration, quality, and compliance concerning small molecule drug substances.
- Cross-functional understanding related to API development from pre-IND through NDA stages.
- Chemistry Manufacturing Controls (CMC) expertise to prepare technical documents for regulatory filings (e.g. IND to NDA).
- Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs.
- Excellent interpersonal and leadership skills, excellent communication, interpersonal and presentation skills.
- Strong discernment including business contracting expertise.
- Skills at negotiating with business partners/management and influencing senior-level leaders regarding matters of significance to the organization.
- Proficiency at creating and delivering a clear vision among team members optimally aligning resources and activities to achieve functional area and/or company goals.
This position establishes strategic plans for designated function(s) and participates 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 the functional area and related interpersonal objectives. Erroneous decisions will have a serious impact on the overall success of the organization and the company.
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
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.