Associate Director Analytical Development Drug Substance
Responsible for supervising outsourced analytical development activities associated with the development, validation, and technology transfer for chemical regulatory starting materials, intermediates and active pharmaceutical ingredients. Support characterization of Regulatory Starting Material (RSM), intermediates, and drug substances. Manages multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical development results in reports and certificates of analysis.
- Develops and validates analytical methods for small molecules for raw materials, intermediates and active pharmaceutical ingredients (API):
- Direct the analytical development plans and testing requirements at CSPs
- Collaborates with testing labs to develop analytical methods
- Assess the suitability of analytical methods for the intended purpose
- Drafts and/or reviews/approves method validation protocols and reports
- Drafts and/or reviews/approves analytical methods
- Draft analytical portions of the chemistry, manufacturing, and control (CMC) sections of regulatory documentation
- Provides oversight of testing at CSPs:
- Review testing sections of process development protocols and reports
- Defines testing requirements
- Observe, as needed, testing at CSPs
- Travels to sites to assess technical abilities and for formal planning activities
- Liaises with chemistry, manufacturing, quality, and regulatory counterparts to develop plans and protocols for API development
- Conducts laboratory investigations:
- Investigate and/or review CSP out-of-specification/out-of-trend (OOS/OOT) for scientific soundness and completeness
- Assesses the performance of CSP laboratory for accuracy and technical expertise
Education and Experience
- M.S. in Chemistry or related field. Ph.D. preferred
- Targeting 8 years’ experience in progressively responsible roles, with a focus on API analytical development techniques, with 5 years in a leadership role
- Experience authoring technical reports and CMC sections for regulatory filings. Related experience should include hands-on experience in at least one of the following: analytical chemistry techniques: chromatography, thermo analysis and/or spectroscopic techniques
- Experience with oversight management of CSP analytical laboratory preferred
- Strong understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH guidances, 21 CFR Part 211, 21 CFR Part 11)
- Working knowledge of United States Pharmacopeia (USP), European Pharmacopeia (EP)
- Proven problem-solving abilities
- Strong organizational and documentation skills
- Demonstrated effective verbal and written communication skills
- Ability to manage change in a dynamic environment
- Strong understanding of analytical methods required for testing small molecules and peptides throughout their synthetic steps
- Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the department or segments of the organization
- Adept at crafting and communicating a clear vision among team members optimally aligning resources to achieve functional area goals
- Ability to travel 20% of the time, both domestically and internationally
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. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business needs.
What we offer you (US-Based Employees):
- 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
EEO Statement (US-Based Employees): 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 firstname.lastname@example.org 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.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.