Boston, MA, Carmel, Indiana, United States, Remote

Position: Analytical Development (Senior Manager – Associate Director)

Position Summary

Karuna is looking for individuals to join our CMC team to help lead analytical development in support of small molecule drug development from Phase 1 to commercialization. The position is responsible for managing contract partners in analytical method development, method validation, release testing, and stability testing of APIs and drug products for all Karuna global development programs, from phase 1 to commercial registration. The position is accountable for overseeing contract partners' scientific rigor and quality of analytical work. This individual will be a member of the Karuna CMC teams and report to the Executive Director, Analytical Development.

Responsibilities

• Leads science-driven, phase-appropriate, and risk-based analytical development and specification setting to support clinical programs from phase 1 to commercial registration.
• Drives method development, release testing, stability studies, and method validations to enable clinical advancement at contract sites.
• Collaborates with Karuna formulation development and discovery partners.
• Critically reviews contract partners' data and provides timely feedback to secure prompt resolution of technical and quality findings.
• Works collaboratively with cross-functional partners to proactively communicate analytical outcomes that may impact other areas and solicit input to drive analytical activities to timely and quality finish in support of overall project timelines.
• Work closely with contract partners to build relationships and obtain the necessary support and resources to complete Karuna projects.
• Authors and reviews relevant sections of CMC documentation in support of INDs, IMPDs, NDA submissions and amendments, and information package in support of meetings with regulatory authorities.
• As a subject matter expert on multiple projects, author and review technical reports, memos, change control documents, and deviation and investigation reports to capture development efforts, rationales, and justifications of Karuna approaches and positions.
• Follows Karuna process to drive change control, perform impact assessment and lead material review board technical discussions.
• Serves as a CMC team member, assesses capabilities and processes, and promotes best practices for continuous improvement for the CMC team.

Required Qualifications

• Master’s degree in analytical chemistry with a minimum of 10 years of method development (or a Ph.D. with 7 years experience) experience in the pharmaceutical industry is required.
• In-depth technical understanding of all aspects of small molecule analytical testing, process controls, and characterization of APIs and pharmaceutical products. Stays current with industry trends.
• Direct experience in CMC analytical and regulatory requirements, including developing product specifications and extended analytical characterization to support late-stage product development and global commercial registration submissions.
• Mass spectrometry background to include method development and validation and structure elucidation.
• Prior experience managing contract manufacturing organizations and contract laboratories, including data review and oversight of product release and stability testing.
• Is detail-oriented has excellent follow-through, and is persistent in ensuring investigations are resolved promptly.
• Accomplishes results through individual contributions with significant independence in their assignments and flexibility in embracing changes.
• Demonstrates advanced team facilitation skills that consistently foster effective brainstorming and decision-making.
• Provides budget input as needed for the team to make decisions.
• Uses good judgment in effecting compromise to resolve conflicts. Develops and implements department processes that directly support and may significantly impact team performance.

• Excellent written and oral communication skills, with the ability to communicate complex information allowing for an open and effective dialogue throughout the company.
• Strong organizational skills with the ability to effectively multi-task and prioritize.
• Ability to flexibly adapt to changing business needs and meet timelines.
• Strong attention to detail and quality is critical to success.
• Resourceful, self-starter, and team player with a strong results orientation
• Able to command respect from peers and capable of highly independent work and being a team player and role model.
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
• A proven ability to manage multiple projects and identify and resolve issues.
• Broad experience in an emerging, publicly-traded company environment is a plus.

The successful candidate will also embody our values:

Our purpose is to create value for those we have the privilege to serve:

• We take pride in our work
• We keep our promises and deliver
• We are driven to meaningfully innovate
• We succeed through inclusion and teamwork

Karuna Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Karuna Therapeutics requires all employees to be fully vaccinated by an approved vaccine against COVID-19, including a booster dose if it has been more than eight months since the employee's original vaccination, unless you need an exemption due to disability, pregnancy or conditions related to pregnancy or religion or unless otherwise provided by law; in the case of exemption, weekly testing will be required.