Knewin
VP, Operations
Knewin, Bridgewater, Massachusetts, us, 02324
Qualifications
Bachelor's degree in science, engineering, or related field requiredA minimum of 12+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years leadership experienceSubstantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standardsDemonstrated experience in managing commercial manufacturing operationsDemonstrated startup experience or leading organizations through dramatic growthAbility to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environmentMust be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team membersHistory of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planningStrong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountabilityExcellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organizationcGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change managementExperience with Operational Excellence and/or Lean ManufacturingExcellent organizational and communication skillsSelf-motivated and passionate about advancing the field of cell therapySelf-awareness, integrity, authenticity, and a growth mindsetResponsibilities
We are seeking a highly motivated Vice President of Operations who will be responsible for the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy productsThis individual will partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirementsAs such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing, and release of product to patientsThis is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Quality, MS&T, QC, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and FinanceLead, direct, coach, and develop an effective Operations team responsible for daily clinical and commercial production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirementsProvide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely mannerIn charge of the multiple work centers within the facility to ensure high quality and compliant product supply with oversight of production metrics, including Safety, Quality, Compliance, Cost, Delivery, and PeopleOversee the hiring, development, and performance management of staff within operationsLead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical OperationsEstablish critical KPIs, monitor progress and keep critical stakeholders informed of progressLead and actively participate in all regulatory and internal audits of the facilityWork closely with other functional areas to develop and execute against the strategic plan for the manufacturing siteEstablish key stakeholder relationships with internal and external stakeholdersBenefits
$200,000 - $300,000 a year Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock optionsAll displayed pay ranges are approximate, negotiable, and location dependent
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Bachelor's degree in science, engineering, or related field requiredA minimum of 12+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years leadership experienceSubstantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standardsDemonstrated experience in managing commercial manufacturing operationsDemonstrated startup experience or leading organizations through dramatic growthAbility to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environmentMust be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team membersHistory of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planningStrong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountabilityExcellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organizationcGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change managementExperience with Operational Excellence and/or Lean ManufacturingExcellent organizational and communication skillsSelf-motivated and passionate about advancing the field of cell therapySelf-awareness, integrity, authenticity, and a growth mindsetResponsibilities
We are seeking a highly motivated Vice President of Operations who will be responsible for the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy productsThis individual will partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirementsAs such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing, and release of product to patientsThis is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Quality, MS&T, QC, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and FinanceLead, direct, coach, and develop an effective Operations team responsible for daily clinical and commercial production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirementsProvide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely mannerIn charge of the multiple work centers within the facility to ensure high quality and compliant product supply with oversight of production metrics, including Safety, Quality, Compliance, Cost, Delivery, and PeopleOversee the hiring, development, and performance management of staff within operationsLead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical OperationsEstablish critical KPIs, monitor progress and keep critical stakeholders informed of progressLead and actively participate in all regulatory and internal audits of the facilityWork closely with other functional areas to develop and execute against the strategic plan for the manufacturing siteEstablish key stakeholder relationships with internal and external stakeholdersBenefits
$200,000 - $300,000 a year Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock optionsAll displayed pay ranges are approximate, negotiable, and location dependent
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