Since its inception over a decade ago,CRISPR Therapeuticshas 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 Therapeuticshas established strategic partnerships with leading companies includingBayerand Vertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug, Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco, California, and business offices inLondon, United Kingdom.
Position Summary
The Sr. Manager, Operational Excellence is responsible for driving continuous improvement initiatives within the CRISPR Framingham manufacturing organization to enhance efficiency, quality, and cost. They will lead process improvement projects, identify opportunities for optimization, and implement best practices to streamline operations. This is an exciting and visible role for a highly qualified and motivated individual. This role will report directly to the Head of Technical Operations Program Management.
Responsibilities
Develop and implement process improvement strategies to enhance operational efficiency and effectiveness.
Lead cross functional teams, and process improvement projects, including defining project scope objectives, and timelines. Analyze current processes, identify areas of improvement, and recommend solutions to streamline workflows.
Utilize Lean 6 Sigma or other process improvement methodologies and tools to drive process excellence initiatives.
Collaborate with stakeholders at all levels of the organization to ensure alignment and buy-in for process improvement initiatives.
Monitor and track key performance indicators (KPIs) to measure the impact of process improvements and sustainable change.
Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.
Provide training and support to employees on process improvement methodology and tools.
Stay current on industry best practices and trends and process excellence to continuously improve processes.
Minimum Qualifications
Bachelor's and 10+ years of relevant experience or advanced degree 8+ years relevant experience, including 3+ years of experience leading project improvement initiatives.
Prior GMP experience required.
Expertise in process improvement methodologies such as Lean Six Sigma (e.g.,, Value Stream Mapping, Kaizen) or other continuous improvement frameworks.
Proven ability to deliver sustained operational improvements.
Excellent project management skills with the ability to lead cross functional teams and deliver results on time within budget.
Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
Strong leadership skills, including demonstrated ability to influence at all levels of an organization.
Detail-oriented with a focus on continuous improvement and driving change.
Excellent oral and written communication skills, including presentation and facilitation skills,
Preferred Qualifications
Lean 6 Sigma Certified strongly preferred.
Knowledge of biotechnology/pharmaceutical product technical transfer, manufacturing, and quality control strongly preferred.
Experience with process mapping and process optimization tools/software.
Strong problem-solving skills and a proactive approach to identifying opportunities for improvement.
Ability to work independently and as part of a team in a fast-paced environment.
Competencies
Collaborative - Openness, One Team.
Undaunted - Fearless, Can-do attitude.
Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.