Position Overview:

Beam is seeking a highly energetic, talented and motivated Regulatory/Quality Co-op to join our growing Regulatory and Quality teams from January through June 2024. This candidate rotates between Regulatory, Quality Assurance and Quality Control in three separate segments to provide the individual exposure to all three departments.

Quality Assurance

As part of the Quality Assurance GMP Operations team, the candidate will support current good manufacturing practices (cGMP) activities in all of our contract development manufacturing organizations/external partners. The position will assist in ensuring batch reviews and associated Quality Processes (e.g., deviations, change control, protocols, etc.) are progressed in a compliant and timely manner and ensure cGMP compliance is maintained. The candidate will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations. The candidate in Quality Assurance 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. The Quality Control team tests a variety of products including cell banks, plasmids, gRNA, mRNA, lipids, cell therapies and LNPs (lipid nano particles). Quality Control also works with many different types of methods for example bioburden, Solo VPE, HPLC, cell based, ELISA, and sequencing. The Quality Control team is responsible for determining the stability and shelf-life of products. The candidate in Quality Control will gain experience navigating real world projects related to product testing and stability.

Regulatory Affairs

The candidate will support the Regulatory Affairs team by performing research for regulatory intelligence, summarizing guidances as well as support data verification and data entry into program spreadsheets. The candidate will gain experience in navigating real world projects related to health authority interactions and submission processes for investigational products.

Responsibilities:

Quality Assurance

• Quality Assurance Co-op for external collaborations will help provide quality system expertise and help identify solutions and ensure compliance to GMP.
• 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 and approve deviations, change controls and Corrective and Preventive Actions (CAPAs) for appropriateness, completeness and to meet internal procedures and regulatory expectations.
• Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
• 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.
• Supports analytical method qualification, method transfer, and lab investigations as necessary.
• Applies learned technical knowledge of QA/QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems.

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.

Regulatory Affairs

• Summarize and index relevant guidance.
• Create, design, and general upkeep of Regulatory SharePoint Site.
• Create chronology logs for active programs.
• Research for to build the regulatory intelligence platform.
• Perform research to Create data verification/Quality Control process.
• Perform data verification.
• Investigate possibility of Drug Master File for guide RNA.

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.