Director of GMP Process Development

2 weeks ago

New York, New York, United States nyscf Full time
Job Title: Director of GMP Process Development

We are seeking a highly skilled and experienced Director of GMP Process Development to join our team at the New York Stem Cell Foundation (NYSCF). As a key member of our organization, you will play a critical role in the development of cGMP processes and assays for autologous and allogeneic INDUCED PLURIPOTENT STEM CELL (IPSC) BASED cell therapies.

Responsibilities:
  • Manage a team to develop procedures and methods related to the production of live cells at both bench and manufacturing scales.
  • Develop novel cell culture, reprogramming, and next generation differentiation steps to increase yield and process robustness.
  • Identify and implement necessary changes to process and reagents for GMP compliance.
  • Execute technology transfer projects, resolve processing issues, and conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials.
  • Identify assays for product characterization in collaboration with existing lab personnel, including: identity, purity, potency, and mechanism of action.
  • Lead effort in FMEA and DOE to develop experimental plan for identification of Critical Process Parameters, ranges and criteria for iPSC and differentiated cell therapy products.
  • Create CMC Master File/IMPD submissions, prepare process descriptions, and draft information for batch records.
  • Provide technical and on-the-floor support to assist in the troubleshooting of clinical drug substance manufacturing.
  • Support the GMP manufacturing process.
  • Create and maintain accurate and complete development records and protocols.
  • Communicate in written and oral form with a multidisciplinary team including: Investigators, Scientific Staff, Quality Assurance, Manufacturing, Operations, R&D, etc.
Requirements:
  • PhD in Biology/Biochemistry or other relevant field with a minimum of 5 years of experience in a development laboratory in the field of cell therapy or involving cell culture.
  • At least 3 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
  • Experience with Design of Experiment (DOE) and JMP/SPSS or other relevant statistical software.
  • Experience in transferring a development process into GMP manufacturing, developing a tech transfer package, acting as subject matter expert for tech transfer.
  • Knowledge of FDA and EU cGMP regulations and requirements as they relate to process and assay development.
  • Experience in developing assays for transfer into a GMP testing lab.
  • Understanding of cell culture processes, such as: scale up factors from bench to clinical/commercial, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes, harvest and clarification processes.
  • Excellent written, verbal, and interpersonal communication skills.
  • Demonstrated ability to work independently.
  • Able to analyze and interpret data.
  • Be a self-starter with the ability to take on several projects at one time.
  • Excellent critical thinking, organizational, and analytical skills.
  • Highly motivated, with the ability to work independently and as a leader of a team of either direct reports or matrix-project based reports.
  • Adaptability to work in a fast-paced and changing environment.

NYSCF is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

  • Senior Director, Process Development Lead

    3 days ago

    New York, New York, United States Fraser Dove International Full time

    Senior Director, Process Development OpportunityFraser Dove International is partnering with a leading biopharmaceutical company to find a seasoned leader to oversee the Process Development function. As Senior Director, Process Development, you will be responsible for managing key client account programs, maintaining strong business relationships, and...

  • Senior Director, Process Development Lead

    2 weeks ago

    New York, New York, United States Fraser Dove International Full time

    Senior Director, Process Development OpportunityFraser Dove International is partnering with a leading biopharmaceutical company to find a seasoned leader to oversee the Process Development function.This is a key role that offers substantial growth opportunities within a forward-thinking organization.Key Responsibilities:Manage key client account programs...

  • Senior Director, Process Development Lead

    1 week ago

    New York, New York, United States Fraser Dove International Full time

    Senior Director, Process Development OpportunityFraser Dove International is partnering with a leading biopharmaceutical company to find a seasoned leader to oversee the Process Development function.This is a key role that offers substantial growth opportunities within a forward-thinking organization.Key Responsibilities:Manage key client account programs...

  • Senior Director, Process Development Lead

    2 days ago

    New York, New York, United States Fraser Dove International Full time

    Senior Director, Process Development OpportunityFraser Dove International is partnering with a leading biopharmaceutical company to find a seasoned leader to oversee the Process Development function.This is a key role that offers substantial growth opportunities within a forward-thinking organization.Key Responsibilities:Manage client account programs and...

  • Senior Director, Process Development Lead

    3 weeks ago

    New York, New York, United States Fraser Dove International Full time

    Senior Director, Process Development OpportunityFraser Dove International is partnering with a leading biopharmaceutical company to find a seasoned leader to oversee the Process Development function.This is a key role that offers substantial growth opportunities within a forward-thinking organization.Key Responsibilities:Manage client account programs and...

  • GMP Kilo Lab Operations Manager

    2 weeks ago

    New York, New York, United States TPG Staffing, LLC Full time

    Job Title: Director/Manager of GMP Kilo Lab OperationsTPG Staffing, LLC is seeking a highly qualified candidate to serve as Director/Manager of GMP Kilo Lab Operations in our central NJ location.Job Summary:The selected individual will be responsible for overseeing our Kilo Lab and ensuring that best practices are followed in all areas of its operation and...

  • GMP Sanitization Specialist

    6 days ago

    New York, New York, United States Jones Lang LaSalle Incorporated Full time

    About JLLJones Lang LaSalle Incorporated is a leading global provider of real estate and investment management services. We take pride in our commitment to excellence and our dedication to helping our clients achieve their business ambitions.Job SummaryWe are seeking a highly skilled and detail-oriented GMP Sanitization Specialist to join our team. As a key...

  • GMP Custodial Associate

    4 weeks ago

    New York, New York, United States Jones Lang LaSalle SAS Full time

    About Jones Lang LaSalle (JLL)Jones Lang LaSalle is a premier professional services and investment management firm with a focus on real estate. Operating in over 80 countries, our dedicated workforce of more than 91,000 professionals assists real estate owners, occupiers, and investors in achieving their business goals. As a global Fortune 500 entity, we...

  • Development Director

    1 week ago

    New York, New York, United States Gilbane Development Full time

    Development Director - AcquisitionsGilbane Development Company is seeking a seasoned Development Director to join our Purpose Built Student Housing Acquisitions team. As a key member of our team, you will play a pivotal role in shaping our value-add/opportunistic investment platform under the Student Housing Division.ResponsibilitiesLead the sourcing,...

  • Scientific Research Director

    3 weeks ago

    New York, New York, United States Memorial Sloan Kettering Cancer Center Full time

    Job Title: Scientific Research DirectorWe are seeking a highly skilled and experienced Scientific Research Director to lead our RNA Therapeutics Laboratory at Memorial Sloan Kettering Cancer Center.Job Summary:The successful candidate will oversee the creation of an independent mRNA vaccine pipeline, encompassing vaccine platform optimization and GMP...

  • Senior Development Director

    1 week ago

    New York, New York, United States Gilbane Development Full time

    Job Title: Senior Development Director - AcquisitionsGilbane Development Company is seeking a highly skilled Senior Development Director - Acquisitions to join our Affordable & Mixed-Income development team.Job Summary:The Senior Development Director - Acquisitions will play a pivotal role in shaping the company's value-add/opportunistic investment platform...

  • Development Director

    3 weeks ago

    New York, New York, United States Gilbane Development Full time

    About the RoleGilbane Development Company is seeking a seasoned professional to join our Purpose Built Student Housing Acquisitions team as a Development Director. This key position will play a pivotal role in shaping the company's value-add/opportunistic investment platform under the Student Housing Division.Key ResponsibilitiesLead the sourcing,...

  • Scientific Research Director

    1 day ago

    New York, New York, United States Memorial Sloan Kettering Cancer Center Full time

    Job Title: Scientific Research Lead, Head-RNA Therapeutics LabMemorial Sloan Kettering Cancer Center (MSK) is seeking an accomplished, motivated, and innovative individual to head its RNA Therapeutics Laboratory. The Head of the RNA Therapeutics Laboratory will lead a laboratory team envisioned as the nexus for R&D activities in the newly established Center...

  • Director of Process Optimization

    1 week ago

    New York, New York, United States Metropolitan Transportation Authority Full time

    Job Title: Director of Process OptimizationThe Metropolitan Transportation Authority is seeking a highly skilled Director of Process Optimization to join our team. As a key member of our organization, you will be responsible for assessing and optimizing our business processes to ensure they are efficient, effective, and aligned with our strategic goals.Key...

  • Director of Process Excellence

    2 weeks ago

    New York, New York, United States MTA, Inc. Full time

    Job Title: Director Process Optimization, PeopleJob Summary:The Director Process Optimization, People will be responsible for assessing and optimizing business processes across the organization, ensuring alignment with the company's long-term strategy. This role will lead the development of future processes, execute specific initiatives, and collaborate with...

  • Deputy Director of Community Development

    3 weeks ago

    New York, New York, United States DEPT OF YOUTH & COMM DEV SRVS Full time

    Job Title: Deputy DirectorJoin the DEPT OF YOUTH & COMM DEV SRVS team as a Deputy Director and contribute to the development of community-based programs that alleviate poverty and provide opportunities for New Yorkers to flourish.Job SummaryThe Deputy Director will assist the Director in overseeing the ongoing operations of Workforce programs, managing...

  • Deputy Director

    2 weeks ago

    New York, New York, United States DEPT OF YOUTH & COMM DEV SRVS Full time

    Job Title: Deputy DirectorJoin the DEPT OF YOUTH & COMM DEV SRVS team as a Deputy Director and play a key role in overseeing the ongoing operations of Workforce programs. As a seasoned professional, you will manage processes, establish program priorities, and ensure adherence to established Agency procedures.Key Responsibilities:Assist the Director in...

  • Director of Business Development

    4 weeks ago

    New York, New York, United States Bristal Assisted Living Full time

    Job DescriptionThe Corporate Director of Sales will be responsible for shaping the strategic direction and fostering business growth for Bristal Assisted Living. Providing comprehensive oversight of strategic planning and business development functions and overseeing the Regional Directors of Sales and Directors of Business Development. In this role, you...

  • Senior Managing Director of Development

    6 days ago

    New York, New York, United States Board of Jewish Education Full time

    Job Title: Senior Managing Director of DevelopmentRootOne is seeking an experienced and dynamic leader to join our team as Senior Managing Director of Development. This is a unique opportunity to make a significant impact on the organization's growth and success.About the RoleThe Senior Managing Director of Development will be responsible for leading all...

  • Director of Process Optimization

    1 week ago

    New York, New York, United States MTA, Inc. Full time

    Job Title: Director of Process OptimizationThis is a key leadership role responsible for assessing and optimizing business processes across the organization. The successful candidate will have a strong background in process improvement and a proven track record of delivering results.Key Responsibilities:Assess current business processes and identify areas...