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

Position: Technical Operations (Senior Manager – Associate Director)

Position Summary

Karuna Therapeutics is seeking a highly motivated professional with experience in cGMP API manufacturing to join the Technical Operations group. This position will be responsible for managing the external drug substance manufacturing activities. This will be an integral part of the company’s effort to discover and develop exciting first-in-class molecules targeting CNS afflictions, including psychosis. This is a unique opportunity to work with a well-funded and proven leadership team in a rapidly growing company.

Responsibilities

• Manage commercial manufacturing of API’s at external suppliers. Deliver APIs on time in full and in cost-effective manner.
• Review executed batch records and batch data.
• Effectively address deviations, OOS/OOT investigations, perform root cause analyses and assign appropriate CAPA’s.
• Manage process/method changes using a formal change control system.
• Develop relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.) and stay current on industry trends and practices.
• Collaborate closely with internal functional groups such as AD, QA, RA, DP, SC and QC.
• Evaluate current chemical processes for potential improvements in yield, scale and cycle time.
• Draft drug substance sections for regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers)
• Participate in the selection, evaluation and approval of new third-party contractors and suppliers for drug substance development activities (as needed).
• Identify and mitigate potential regulatory and quality risks for the drug substance manufacture and subsequent resolution of compliance and quality issues.
• Ensure adequate documentation processes and systems are available and followed for drug substance synthesis, testing and release (SOPs / Protocols review /approval).

Required Qualifications

• Must hold a minimum of 6 years relevant work experience with a PhD in organic synthesis or a minimum of 10 years relevant work experience with a Bachelors/Masters degree.
• Experience working with small molecule process development particularly in greater that 50 kg scale chemical development, tech transfer and manufacturing of registration batches.
• Process development, technology transfer, process validation and troubleshooting experience with a strong record of problem solving is preferred. Any commercial manufacturing experience will be a plus.
• Strong knowledge of applied analytical methodology relating to in-process controls, drug substance release testing and stability assessment.
• Ability to effectively organize and prioritize tasks to achieve established deadlines.
• Knowledge of cGMPs, ICH guidelines, FDA and EMA/CHMP (and other international) regulatory requirements.
• Experience working through NDA process from the CMC side a plus.
• Ability to travel, expected at 10-15%/year.

• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Attention to detail and quality are critical to success.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• 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.
• 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.
• Forward thinking mindset with the 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 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.