Process Development, Drug Product, CMC (Principal Scientist-Senior Manager)
Company: Karuna Therapeutics, Inc.
Posted on: June 13, 2021
Position: Process Development, Drug Product, CMC (Principal
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.
- 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
- 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
- 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
- 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
- Collaborate with QA functions and associated functions to
ensure implementation of highest possible quality standards
throughout manufacturing and process development impacting drug
- Support with timely presentations and updates as necessary to
- 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
- Other duties as needed.
- 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
- 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
- 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
- Teamwork: We can only win by working together toward our common
- 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
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