Sr. Scientist/Principal Scientist/Associate Director Chemistry Manufacturing and Control (CMC)
Calibr was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Calibr, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Scripps Research is ranked the most influential institution in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr’s drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team.
POSITION TITLE: Sr. Scientist/Principal Scientist/Associate Director Chemistry, Manufacturing and Control (CMC) Small Molecules
RESPONSIBILITIES AND DUTIES:
- Work closely with Calibr’s scientists on development of lab-scale synthetic, analytical and formulation projects.
- Develop synthetic plans and design and run experiments to test their suitability for large-scale use
- Manage CMOs in API, formulation and fill/finish development and manufacturing in cost-effective manner. Improve and troubleshoot existing processes to reduce cost and increase reliability, purity, and safety
- Use simulation or modelling software to analyze extensive data sets and determine how changes in process affect the final product
- Utilize fundamental process chemistry principles to characterize and solve manufacturing process challenges. Use a variety of analytical methods to monitor reaction processes
- Define critical quality attributes and establish robust control strategies via comprehensive process parameters assessment.
- Ensure that regulatory starting materials and API process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively overseeing process development and manufacturing campaigns.
- Review batch records, process validation plans and protocols, manufacturing campaign reports.
- Works cross-functionally to deliver regulatory documents and supporting documentation in support of Calibr’s regulatory filings.
- Prepare technical reports, patent application content, publications and oral presentations as necessary.
- Responsible for participating in the preparation of technical transfer documents for manufacture at third parties.
- May direct appropriate use of FTE and budgetary resources to support project and corporate goals
- Develops long-term plans and sets priorities within constraints of project goals/timelines. Examples include:
- Mapping out activities/timing required to develop a pre-clinical or Phase I and II process including interaction with and deliverables from other functional areas to determine appropriate material requirements, assay requirements, etc.
- Mapping out activities and timing to support development of Pre-clinical or Phase I/II processes including pre-validation support activities such as process robustness, scale-up, transfer to manufacturing suites.
- Independently designs, executes, interprets and reports results of their work. Additionally, oversees consistency and accuracy of results and documentation.
- Expected to solve the majority of problems that arise with little supervisory input.
- Has attained credibility within lab group by performing high quality work.
- Initiates and gains commitment and support for expansion of the conceptual framework or the technical capabilities of Process Development Group.
- Teaches others regarding their expertise and knowledge of the organization, mentoring and training other members of Process Development Group as appropriate.
- Effectively communicates results of own work though scientific meetings, presentations, discussions and documentation.
- Expected to review/critique/question the science within Process Development.
- MS or PhD in chemistry, Medicinal Chemistry, synthetic chemistry, bio-organic chemistry or related field with 5-15+ years’ experience in pharmaceutical industry
- Proven track record of successfully overseeing chemical process development.
- In-depth knowledge of synthetic organic chemistry, chemical process development and efficient process throughput concept. Familiarity with common industrial unit operations including crystallization (batch and continuous mode), filtration and drying
- Hands on experience including but not limited to the following analytical methods: RP-HPLC, UV-Vis; HR-MS, LCMS-QTOF, XRD and other analytical methods is required.
- Experience in analytical development and qualification for therapeutic candidates in support of IND-enabling studies for Phase I clinical trials is desirable.
- Familiarity with the use of design of experiments (DoE) and Process Analytical Technology (PAT) techniques
- Familiarity with current Good Manufacturing Practices for preparing drug substances, intermediates, and drug product
- Proven track record of successfully working with/managing CDMO’s/CMO’s.
- Experience working with analytical and formulation development, quality assurance and control teams.
- Experience with contributing to CMC sections of clinical trial and marketing applications.
- Excellent interpersonal, verbal and written communication skills.
- Comfortable in a fast-paced environment and able to adjust based upon changing priorities.
- Highly motivated, creative, and devoted to project goals.
- Good hands-on experience with crystallization, filtration and chromatography-based processing methods
- Demonstrate a strong working knowledge of current Good Manufacturing Processes (GMP). Compliance on safety and regulatory requirements is expected and documented through Calibr’s internal and external training program.
- Technology transfer of processes to cGMP CMOs. Prior “man in plant” experience is desirable.
- Able to think in terms of global long-term project goals as well as day-to-day lab goals/activities.
The above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of Scripps Research, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff.
Scripps is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
The safety and well-being of our candidates, our people and their families continues to be a top priority. Until restrictions change, interviews will be conducted virtually.