Scientist I Formulation
Charles River Laboratories
Shrewsbury, MA 01545
Date Acquired : 5/8/2019 12:03:18 AM
Date Updated : 6/16/2019 10:55:24 PM
Scientist I Formulation
Req ID #: 44194
Shrewsbury, MA, US, 01545
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, well help you build a career that you can feel passionate about.
We are seeking an experiencedScientist I, Formulation Developmentfor ourBiologics grouplocated inShrewsbury, MA.
In this position, the Scientist I will be responsible for assisting in the development of project strategies, and the independent execution of pre-formulation and formulation development (liquid/ lyophilized) tasks for different biomolecules including peptides, therapeutic proteins, monoclonal antibodies (mAb), vaccines and oligonucleotides; work performed under the supervision of senior formulations staff.
Other responsibilities include providing scientific support in identifying novel formulations, and delivery technologies that can advance the current standard of care and lead larger programs which may include multiple projects. Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Hands on experience in liquid and lyophilized bioformulation development, formulation optimization and robustness studies. Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/ trainer. With the aid/supervision of senior staff, generate protocols for different stability study types, including development stability studies, IND-enabling stability studies, long-term stability studies, etc. Execute statistical data analysis for prediction of drug substance retest date and drug product shelf-life. Assist senior staff in the interaction with clients in support of formulation needs. Generate pre-formulation and formulation technical reports, as well as technology transfer reports. Participate in formulation process transfer to Sponsors manufacturing and other CMOs in support of fill-finish of drug product. Remain current with the scientific knowledge and practices in the development and formulation of biological products. Incorporate new technologies into the formulation practices within the Company.
The following are minimum requirements related to the Scientist I Formulation Development position.
+ Bachelors degree (B.A. /B.S.) or equivalent in Biochemistry or related scientific discipline. M.S. or Ph.D. preferred.
+ At least two (2) years of relevant experience within a contract research, academic or pharmaceutical industry, including experience in Pharmaceutics Sciences or related field and industry experience in biologic formulation development.
+ An equivalent combination of education and experience with contract research or the pharmaceutical industry may be accepted as a satisfactory substitute for the specific education and experience listed above.
+ Versatile in common biochemical and biophysical characterization techniques for biologics and must have a thorough understanding of the degradation pathways for protein therapeutics in liquid and lyophilized formulations. Must have experience and knowledge in common analytical and formulation practices and procedures including design-of-experiments (DOE), HPLC/UPLC, MS, CE, DSC, MFI, CD, FT-IR and light scattering methods. Solid knowledge of regulatory agencies like FDA and ICH guidelines associated with drug product development, along with drug substance and drug product stability assessment is necessary. Some familiarity in container/closure systems is required. Positive engaging personality, excellent technical leadership, communication (verbal and written) and collaborative skills to work in multidisciplinary teams.
+ Regularly observes, inspects and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors
+ While performing the duties of this job the employee is regularly required to wear personal protective equipment (safety glasses or goggles, face shield, gloves, respirator et al.), work near toxic or caustic chemicals, and work with biohazards.
+ Occasional travel required.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
At Charles River, we are passionate about our role in improving the quality of peoples lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet