Beam Therapeutics
Senior Director, Quality Control
Beam Therapeutics, Cambridge, Massachusetts, us, 02140
Company Overview
Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable 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.
Position Overview:
The Sr. Director of Quality Control, Massachusetts will be responsible for the quality control organization at Beam’s Massachusetts facility. The position will be responsible for the QC technical support teams including all aspects of the method lifecycle, stability programs, and overall program control strategy. Depending on the candidate the position will may also provide oversight of QC internal testing group. The position will take a key role in developing and execution of the long-term quality control testing and quality control support strategy for early phase programs. The position will report into Beam’s VP of Global Quality Control.
Responsibilities:
Provide overall CMC Quality Control leadership across multiple programs and cross-functional forums.
Develops and executes QC strategies for method qualification, transfer, and validation in partnership with Analytical Development and other key roles (ex. Product Quality Leads).
Provide strategic direction to the Cambridge based Quality Control team(s) performing internal QC testing.
Provide strategic direction to the Quality Control Technical Support team accountable for program support and method lifecycle management and stability.
Interact with Beam’s suppliers (ex. CMOs/CTLs) in a QC leadership capacity, as well as Beam’s internal manufacturing site in RTP, NC.
Develops overall monitoring and measures for method/testing aspects: in-process, release, stability testing, OOT/OOS results.
Coordinates with Quality Assurance to ensure contract laboratory service providers are suitably qualified to conduct the services contracted to them.
Coordinates with Quality Assurance to ensure Quality Agreements are complete, approved and updated at appropriate intervals.
Responsible for ensuring cGMP principles are implemented and adhered to within internal and supporting external laboratories.
Ensures quality control systems and equipment are compliant to all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated.
Tracks and trends cGMP data including the evaluation and approval of data received from external contract laboratories. Compiles and reports data with appropriate interpretations for applicable management reviews, Annual Product Reviews, and all other required assessments.
Ensures continuous improvement across the Quality Control Group.
Qualifications:
BS or Advanced degree in a scientific discipline.
15+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
Strong preference for direct experience with cell and/or gene therapy programs.
Experience in leading teams associated with elements of Quality and Quality Control as part of overall background is preferred.
Experience supporting all phases of a program’s lifecycle (pre-IND through commercial lifecycle management).
10+ years of Quality management experience.
Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
Experience interacting with regulatory health authorities at pre- and post-approval inspection.
Solid knowledge of global regulations and standards.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Excellent team building, leadership and management skills.
Excellent listening, communication and interpersonal skills fostering team spirit.
Consistent delivery of high-quality work at all times.
Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.
Location Requirement:
This is a hybrid role however; this role requires that the candidate(s)
live within a reasonable commuting distance to be on site in our Cambridge location several times per week.
#J-18808-Ljbffr
Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable 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.
Position Overview:
The Sr. Director of Quality Control, Massachusetts will be responsible for the quality control organization at Beam’s Massachusetts facility. The position will be responsible for the QC technical support teams including all aspects of the method lifecycle, stability programs, and overall program control strategy. Depending on the candidate the position will may also provide oversight of QC internal testing group. The position will take a key role in developing and execution of the long-term quality control testing and quality control support strategy for early phase programs. The position will report into Beam’s VP of Global Quality Control.
Responsibilities:
Provide overall CMC Quality Control leadership across multiple programs and cross-functional forums.
Develops and executes QC strategies for method qualification, transfer, and validation in partnership with Analytical Development and other key roles (ex. Product Quality Leads).
Provide strategic direction to the Cambridge based Quality Control team(s) performing internal QC testing.
Provide strategic direction to the Quality Control Technical Support team accountable for program support and method lifecycle management and stability.
Interact with Beam’s suppliers (ex. CMOs/CTLs) in a QC leadership capacity, as well as Beam’s internal manufacturing site in RTP, NC.
Develops overall monitoring and measures for method/testing aspects: in-process, release, stability testing, OOT/OOS results.
Coordinates with Quality Assurance to ensure contract laboratory service providers are suitably qualified to conduct the services contracted to them.
Coordinates with Quality Assurance to ensure Quality Agreements are complete, approved and updated at appropriate intervals.
Responsible for ensuring cGMP principles are implemented and adhered to within internal and supporting external laboratories.
Ensures quality control systems and equipment are compliant to all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated.
Tracks and trends cGMP data including the evaluation and approval of data received from external contract laboratories. Compiles and reports data with appropriate interpretations for applicable management reviews, Annual Product Reviews, and all other required assessments.
Ensures continuous improvement across the Quality Control Group.
Qualifications:
BS or Advanced degree in a scientific discipline.
15+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
Strong preference for direct experience with cell and/or gene therapy programs.
Experience in leading teams associated with elements of Quality and Quality Control as part of overall background is preferred.
Experience supporting all phases of a program’s lifecycle (pre-IND through commercial lifecycle management).
10+ years of Quality management experience.
Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
Experience interacting with regulatory health authorities at pre- and post-approval inspection.
Solid knowledge of global regulations and standards.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Excellent team building, leadership and management skills.
Excellent listening, communication and interpersonal skills fostering team spirit.
Consistent delivery of high-quality work at all times.
Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.
Location Requirement:
This is a hybrid role however; this role requires that the candidate(s)
live within a reasonable commuting distance to be on site in our Cambridge location several times per week.
#J-18808-Ljbffr