Regulatory/Quality Co-Op
Beam Therapeutics
Company Overview:
Beam Therapeutics is developing precision genetic medicines through the use of base editing. Beam’s proprietary base editors create precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This enables a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
The Beam Team Is:
- A community of fearless innovators
- Rigorous and honest in our research
- Listening with open minds
- Committed to each other
Position Overview:
Beam is seeking a highly energetic, talented and motivated Regulatory/Quality Co-op to join our growing Regulatory and Quality teams. This candidate rotates between Regulatory, Quality Assurance and Quality Control in three separate segments to provide the individual exposure to all three departments.
Product Quality Assurance/Quality Systems
As part of PQA, the candidate will assist in batch reviews and associated Quality Processes (e.g., deviations, change control, protocols, etc.). The candidate will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations.
As part of the Quality Systems team, the candidate will provide routine support for procedural documents, our Quality Management system and training documentation.
The candidate will gain experience navigating real world projects related to product compliance and oversight.
Quality Control
As part of the Quality Control team, the candidate will provide testing and data trending support for GMP products (e.g., . cell banks, plasmids, gRNA, mRNA, lipids, cell therapies and lipid nano particles). The candidate will also work with many different types of methods for example bioburden, Solo VPE, HPLC, cell based, ELISA, and sequencing.
The candidate in Quality Control will gain experience navigating real world projects related to product testing and stability.
Responsibilities:
Product Quality Assurance/Quality Systems
- Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.
- Review deviations, change controls and Corrective and Preventive Actions (CAPAs) for appropriateness, completeness.
- Support the draft and review of Standard Operating Procedures (SOPs) and related GMP documents.
- Provide Quality Assurance (QA) support to contract manufacturing operations (attend meetings, person in plant review and approval of Contract Manufacturing Organization (CMO) documentation.)
- Monitors and trends batch record errors, provides management with quality indicator data, and collaborates with stakeholders to reduce sources of error.
- Participates in system improvement initiatives to optimize the business processes and practices within Veeva.
- Participates in projects to support Supplier Management and Quality Systems department holistically.
- Assess document metadata within Veeva for missing data and facilitate and department clean-up.
- Assist in organization of the Document Archival Room and enter paper archives into a database for tracking.
- Assist in logbook cleanup around site.
- Remove all learner roles and manager associations for inactive/ineligible users in Veeva.
Quality Control
- The Quality Control Co-op will have responsibility for projects associated with the stability of a product.
- Under the guidance of their mentor, will be accountable for initiating a stability data trending sheet, compiling all the stability data into our document system, recording all the data in the trending sheet, performing trend analysis on the data, and documenting the extension of shelf-life of the product base on the data.
- Perform tasks in the Quality Control laboratory consisting of sample log in, reagent management, buffer preparation and sample testing.
Qualifications:
- Pursuing a Bachelor's degree in Biotechnology, Bioengineering, Biochemistry, or related field.
- Prior industry internship or academic lab-based research experience is preferred.
- The candidate should have a solid academic foundation in science and laboratory coursework (examples: biology/chemistry/biochemistry, biochemical/bioengineering, microbiology, tissue culture, molecular biology, etc.)
- A team player who is curious, motivated to learn, organized, and has good communication skills
- Note, this role will function within a hybrid (partially remote, partially onsite) working environment, and requires a self-motivated individual.