Formulation Research, CMC (Scientist - Senior Scientist)
33 Arch St, Boston, MA 02109 Boston, MA 02109 US
Location: Boston, MA - REMOTE EST
Karuna is seeking an experienced and highly motivated formulation scientist with expertise in developing advanced drug delivery systems of small molecule drugs to join the CMC group to work on exciting molecules targeting CNS afflictions. Reporting to the Director, Formulation Research, this position will play a critical role in supporting drug product development from the preclinical phase to Phase II clinical trials.
- Leads early-stage formulation development for current and future drug products.
- Assesses product developability of New Chemical Entity and proposes formulation strategy in support of preclinical and clinical development.
- Develops new formulations to improve drug absorption and pharmacokinetics for life cycle extension.
- Collaborates with preclinical team for in vivo PK evaluation of formulations.
- Works closely with Chemical, Analytical, Drug Product, Regulatory, and QA groups internally to develop high quality formulations meeting regulatory requirements.
- Designs studies; instructs and monitors development activities at CROs.
- Keeps abreast of novel drug delivery systems and technologies.
- Drives technical transfer and tracks the execution of cGMP manufacturing. Ensures adequate documentation of drug product development and manufacture for production, testing, and release (SOPs / Protocols review /approval).
- Drafts formulation development reports, and relevant IND and NDA CMC sections.
- Provides presentations and updates as necessary to management.
- Preferably a Ph.D. in Pharmaceutics, Chemical or Biochemical Engineering with 7-10 years of pharmaceutical industry experience, or a minimum of 14+ years relevant work experience with a MSc degree.
- Broad scientific knowledge in pre-formulation, biopharmaceutics (in-silico, in-vitro and in-vivo), pharmacokinetics, drug delivery, and associated technologies.
- Proven success in developing and manufacturing both oral and non-oral drug products to support different stages of clinical development.
- Experience in developing advanced drug delivery systems for targeting delivery or enhancing drug permeability or solubility is preferred.
- Working knowledge of analytical methodology and chemistry required for drug product development.
- Minimum of 3 years of experience in drafting formulation development reports, pharmacy manuals as well as drug product sections of INDs, IMPDs, and NDAs.
- Proven track record in CRO and CDMO management.
- 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.
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