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Sr. Scientist/Principal Scientist/Associate Director Chemistry Manufacturing and Control (CMC)

Employer
Scripps Research.
Location
La Jolla, California
Salary
Commensurate with experience.
Closing date
Sep 24, 2021

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ABOUT US 
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)

 

RESPONSIBILITIES AND DUTIES:

  • Work closely with Calibr’s scientists on development of lab-scale upstream, downstream, analytical and formulation projects.
  • Manage CMOs in upstream, downstream, formulation and fill/finish development and manufacturing
  • Document writing, data interpretation, presentation, statistical analysis and trending; authoring and review of regulatory submissions such as IND
  • Implement knowledge/expertise within a lab group/project team to successfully execute major parts of a project.  This should involve a complement of technical and logistical/strategic activities.  Examples may include:
    • Process development and production of protein-based therapeutics and intermediate products, such as plasmids, viral vectors or synthetic molecules
    • Primary recovery of the cell paste, inclusion bodies and specific proteins
    • Interacting with appropriate internal and external upstream, analytical and downstream functional areas to determine appropriate configuration of process development outputs
    • Participation in decision-making processes within the project team by actively engaging in scientific and technical discussions.
    • Responsibility to address the regulatory filings questions
    • Serving as a development team leader
    • Chairing a specific meeting with CMOs
  • Activities are to be carried out efficiently in a scientifically rigorous manner.
  • Addresses problems of increasing complexity relative to those faced by lower levels.
  • Assumes a role of Project Leader for a new product.
  • May direct appropriate use of FTE and budgetary resources to support project and corporate goals
  • Able to think in terms of global long-term project goals as well as day-to-day lab goals/activities.
  • 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.
  • 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.
  • Details of established essential functions for this position will be addressed/discussed during the interview process.

 

REQUIREMENTS:

  • MS or PhD in biology, chemical biology, biochemistry or related area with 5-15+ years’ experience in biopharmaceutical industry
  • Impeccable attention to detail, and excellent ability to perform hands on experiments, research, design, and organize project designs and maintain detailed documentation.
  • Highly motivated, creative, and devoted to project goals.
  • Able to collaborate proficiently and communicate effectively with colleagues, management teams and CMOs.
  • Has considerable breadth of knowledge/expertise relevant to development of bio/pharmaceuticals (recombinant proteins, mAbs, VLPs, viral vectors, cell therapy).
  • Knowledge/expertise in Mammalian and Bacterial Upstream Process Development support, including hands on experience with fermenters and bioreactors of different scale
  • Basic cell culture handling, protein expression and purification methods
  • Experience or understanding of cellular therapies is desirable
  • Good hands on experience with chromatography-based processing methods and filtration techniques
  • Experience with GE Healthcare’s AKTA line of chromatography systems is desired.
  • Technology transfer of upstream and downstream processes to cGMP CMOs. Prior “man in plant” experience.
  • Experience in analytical development and qualification for protein therapeutics in support of IND-enabling studies for Phase I clinical trials is desirable.
  • Hands on wet-lab experience including but not limited to: SE HPLC, RP-HPLC, AEX, UV-Vis; experience with HR-MS, LCMS-QTOF, and flow cytometry is desirable.
  • Protein biochemistry (protein folding, protein degradation, aggregation, etc)
  • Able to contribute in a meaningful way to scientific discourse.
  • Has attained credibility within lab group by performing high quality work.

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. 

 

EEO Statement:
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.

 

COVID-19 update: 

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. 

 

 

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