CRISPR Therapeutics
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Manufacturing Associate, LNP
role at
CRISPR Therapeutics
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly‑owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state‑of‑the‑art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment.
Responsibilities
Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting
Transfer raw material inside cleanroom suite using sanitizing reagents or equipment
Participate in technology transfer from Process Development to the Manufacturing group
Assist in the life‑cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups
Ensure all materials and equipment are identified and available in time for manufacturing operations
Execute standard work per manufacturing schedule
Participate in Quality investigations and resolutions
Ensure cGMP compliance through consistent execution
Other duties and projects as assigned to meet departmental requirements
Minimum Qualifications
Certificate, associate’s degree or higher in biological sciences or related fields and 2‑5 years of relevant Manufacturing experience or related fields
Available to work a flexible schedule as needed
Ability to don cleanroom garments and work within a classified environment (Grade B and C)
Knowledge of GMP and industry standards
T‑Mix and TFF experience preferred
Fluency in Windows and Microsoft Office applications
Attentive to detail and accuracy
Effective communication and collaboration with internal stakeholders
Team‑orientated, results‑focused, ability to follow through to completion
Ability to lift 40 pounds
Ability to stand for 6 hours in a clean room environment
Self‑driven, independently motivated, data‑driven, excellent problem‑solving ability
Competencies
Collaborative – Openness, One Team
Undaunted – Fearless, Can‑do attitude
Results Orientation – Delivering progress toward our mission; sense of urgency in solving problems
Entrepreneurial Spirit – Proactive, ownership mindset
Salary Manufacturing Associate: Base pay range of $40.00 per hour to $44.00 per hour + bonus, equity and benefits.
Benefits Due to the nature of their work, our manufacturing and lab‑based positions are located fully on‑site.
Equal Employment Opportunity CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
Privacy Statement To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
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Manufacturing Associate, LNP
role at
CRISPR Therapeutics
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly‑owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state‑of‑the‑art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment.
Responsibilities
Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting
Transfer raw material inside cleanroom suite using sanitizing reagents or equipment
Participate in technology transfer from Process Development to the Manufacturing group
Assist in the life‑cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups
Ensure all materials and equipment are identified and available in time for manufacturing operations
Execute standard work per manufacturing schedule
Participate in Quality investigations and resolutions
Ensure cGMP compliance through consistent execution
Other duties and projects as assigned to meet departmental requirements
Minimum Qualifications
Certificate, associate’s degree or higher in biological sciences or related fields and 2‑5 years of relevant Manufacturing experience or related fields
Available to work a flexible schedule as needed
Ability to don cleanroom garments and work within a classified environment (Grade B and C)
Knowledge of GMP and industry standards
T‑Mix and TFF experience preferred
Fluency in Windows and Microsoft Office applications
Attentive to detail and accuracy
Effective communication and collaboration with internal stakeholders
Team‑orientated, results‑focused, ability to follow through to completion
Ability to lift 40 pounds
Ability to stand for 6 hours in a clean room environment
Self‑driven, independently motivated, data‑driven, excellent problem‑solving ability
Competencies
Collaborative – Openness, One Team
Undaunted – Fearless, Can‑do attitude
Results Orientation – Delivering progress toward our mission; sense of urgency in solving problems
Entrepreneurial Spirit – Proactive, ownership mindset
Salary Manufacturing Associate: Base pay range of $40.00 per hour to $44.00 per hour + bonus, equity and benefits.
Benefits Due to the nature of their work, our manufacturing and lab‑based positions are located fully on‑site.
Equal Employment Opportunity CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
Privacy Statement To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
#J-18808-Ljbffr