Qc, Analytical Development (Manager – Senior Manager)

Boston, MA (Hybrid)

Position: QC, Analytical Development (Manager – Senior Manager)

Position Summary

Karuna is looking for individuals to join our CMC Analytical Development Quality Control (QC) Team to support our potential commercialization. The position is responsible for QC data review across all manufacturing phases, including release and stability testing of APIs and drug products for any Karuna global commercial programs. The position is accountable for overseeing the scientific rigor and quality of analytical work performed by our contract partners. This individual will be a member of the Karuna CMC team and report to the Executive Director, Analytical Development.

Responsibilities

• Serves as a subject matter expert on multiple projects, and authors and reviews technical reports, memos, change control documents, deviation, and investigation reports capturing development efforts, rationales, and justifications of Karuna approaches and positions.
• Maintains batch-related data and trends for specification setting purposes.
• Critically reviews contract partners' data and provides timely feedback to secure prompt resolution of technical and quality findings.
• Assists in writing and reviewing deviations and OOS investigations, including CAPAs.
• Works closely with contract partners to build relationships and obtain support and resources to complete Karuna projects.
• 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.
• Serves as a member of the CMC team, assesses capabilities and processes, and promotes best practices for continuous improvement to support the CMC team.

Required Qualifications

• Attention to detail and quality are critical to success.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Broad experience in an emerging, publicly traded company environment is a plus.
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Demonstrates advanced team facilitation skills that consistently foster effective brainstorming and decision-making.
• Uses good judgment in effecting compromise to resolve conflicts. Develops and implements department processes that directly support and significantly impact team performance.
• Provides budget input as needed for the team to make decisions.
• Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues.
• Has prior experience in managing contract manufacturing organizations and contract laboratories, including data review and oversight of product release and stability testing.
• Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
• In-depth technical understanding of all aspects of analytical testing, process controls, and characterization of APIs and pharmaceutical products. Stays current with industry trends.
• Accomplishes results through individual contributions with significant independence in their assignments and flexibility in embracing change.
• Minimally a BS degree in Chemistry (or related Science) with a minimum of 8 years (or MS with 5 years) QC experience in the pharmaceutical industry is required.
• Is detail-oriented, has excellent follow-through, and is persistent in ensuring investigations are resolved on time.

The successful candidate will also embody our values:

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

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

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.

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