Process Development, Drug Product, CMC (Principal Scientist-Senior Manager)

Company: Karuna Therapeutics, Inc.
Location: Boston
Posted on: June 13, 2021

Job Description:

Position: Process Development, Drug Product, CMC (Principal Scientist-Senior Manager)

Position Summary

Karuna is seeking an experienced and highly motivated Principal Scientist-Senior Manager, Process Development, Drug Product CMC with expertise in small molecule formulation to join the CMC group and to work on exciting first-in-class molecules targeting CNS afflictions, including psychosis and pain. Reporting to the Associate Director of CMC & Preclinical Development, this position will play a critical role in supporting technology transfer, process development and associated manufacturing in the development of solid/liquid oral dosage forms for use in clinical studies and future validation of drug product manufacturing processes.

Responsibilities

• Lead and support process development & manufacturing work for current and future drug products.
• Monitor and drive the tech transfer and execution of drug product development and cGMP manufacturing plans at external partners (CDMOs) with high quality.
• Proven hands-on experience on equipment's and manufacturing processes commonly used for solid and liquid oral formulation development.
• Being detail oriented, draft, and review high quality manufacturing batch records, protocols and all associated technical documents in collaboration.
• Develop robust manufacturing process, scale up procedures for registration batches by applying QBD approaches as per FDA requirements.
• Draft formulation development reports, relevant IND and NDA CMC sections as well as annual CMC reports with respect to drug formulation and drug product production.
• Support in the selection, evaluation and approval of new third-party contractors and suppliers for drug product development activities (as needed).
• Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
• Collaborate effectively with various functions of CDMO technical operations such as technical process development and analytical to establish phase appropriate control strategy for manufacturing processes.
• Work collaboratively with quality, analytical, drug substance, regulatory, supply chain and project management teams to deliver appropriate drug products for different phases of animal and human studies.
• Collaborate with QA functions and associated functions to ensure implementation of highest possible quality standards throughout manufacturing and process development impacting drug products.
• Support with timely presentations and updates as necessary to management.
• Ensure adequate documentation processes and systems are available and followed for drug product production, testing and release (SOPs / Protocols review /approval).
• Actively communicates, collaborates with, and contributes to other functional areas to solve problems and achieve set goals in a timely manner.
• Other duties as needed.

Required Qualifications

• Ph.D. in pharmacy or pharmaceutics with 5+ years of industry experience in drug formulation or a minimum of 10 years' relevant work experience with a Master's degree.
• Proven success in managing and overseeing CDMOs.
• Experienced in late-stage program development including registration stability and process validation strategies.
• Broad scientific knowledge in pre-formulation, material science and manufacturing processes for formulations administered orally.
• Experience with multiple oral formulation approaches, delayed and sustained release formulations.
• In depth knowledge of analytical methodology required in cGMP manufacturing and release of clinical trial materials.
• Minimum of 3 years of experience in drafting formulation development reports, pharmacy manuals as well as drug product sections of INDs, IMPDs, and NDAs.
• Experience in drafting, reviewing, and approving required documentation pertaining to the development and preparation of drug products under cGMP environment.
• A proven track record of successful development of oral and non-oral dosage forms.
• Strong knowledge of cGMP and QbD approaches to drug product development.
• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
• 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 ability to manage multiple projects, identify and resolve issues.
• Broad experience in a small company environment is a plus

This position is in Boston, Massachusetts.

The successful candidate will also embody our values:

Patients First: Always do right by our patients and their families with a sense of urgency

• Quality & Results: Keep driving toward outcomes while never compromising high standards
• Innovation: Use visionary and novel methods to transform what is possible
• Teamwork: We can only win by working together toward our common goals
• Accountability: Take pride in what we create like it is your own because it is

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.

Keywords: Karuna Therapeutics, Inc., Boston , Process Development, Drug Product, CMC (Principal Scientist-Senior Manager), Other , Boston, Massachusetts