Current jobs related to Lead, Cell Therapy Manufacturing - Cambridge - Vericel Corporation

  • CMC Lead

    2 weeks ago

    Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full time

    About the RoleMEDIPOST America, Inc. is a leading biotechnology company specializing in the development of novel umbilical cord-derived stem cell therapies for the treatment of degenerative diseases. We are seeking an experienced CMC Lead to join our team and lead our cell therapy manufacturing operations.Key ResponsibilitiesStrategic Planning: Develop and...

  • Cell Therapy Manufacturing Team Lead

    2 days ago

    Cambridge, Massachusetts, United States Vericel Corporation Full time

    Job Title: Team Lead, Cell Therapy ManufacturingJob SummaryVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a highly skilled and experienced Team Lead to join our Cell Therapy Manufacturing team. As a key member of our manufacturing team, you will be responsible for leading and overseeing...

  • Team Lead, Cell Therapy Manufacturing

    4 weeks ago

    Cambridge, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty...

  • Team Lead, Cell Therapy Manufacturing

    2 days ago

    Cambridge, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionThis role will be based in our Cambridge, MA location until our new state of the art facility located in Burlington, MA is readyVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and...

  • Cell Therapy Manufacturing Associate

    3 days ago

    Cambridge, Massachusetts, United States Vericel® Corporation Full time

    Manufacturing Associate - Cell TherapyVericel Corporation, a leading innovator in advanced therapies, is seeking a skilled Manufacturing Associate to join our team. As a key member of our manufacturing team, you will play a critical role in the production of commercial cell therapy products.Key Responsibilities:Execute process steps to manufacture cell...

  • Cell Therapy Manufacturing Specialist

    1 week ago

    Cambridge, Massachusetts, United States Vericel® Corporation Full time

    Cell Therapy Manufacturing OpportunityVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a skilled manufacturing professional to contribute to the production of commercial cell therapy products.Key Responsibilities:Execute process steps to manufacture cell therapy products meeting internal and...

  • Manufacturing Associate I

    2 weeks ago

    Cambridge, Massachusetts, United States Vericel® Corporation Full time

    Vericel Corporation, a leading biotechnology company, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics.Job SummaryResponsible for the execution of process steps to manufacture...

  • Director CMC Lead

    3 weeks ago

    cambridge, United States MEDIPOST America, Inc. Full time

    MEDIPOST is Korea’s largest and most trusted umbilical cord blood bank and a commercial-stage cell therapy company. We develop novel umbilical cord-derived stem cell therapies to treat degenerative diseases like Alzheimer’s, Diabetic Neuropathy, and Osteoarthritis.Our flagship product, CARTISTEM, is the world's first allogeneic stem cell therapy for...

  • Director CMC Lead

    3 weeks ago

    cambridge, United States MEDIPOST America, Inc. Full time

    MEDIPOST is Korea’s largest and most trusted umbilical cord blood bank and a commercial-stage cell therapy company. We develop novel umbilical cord-derived stem cell therapies to treat degenerative diseases like Alzheimer’s, Diabetic Neuropathy, and Osteoarthritis.Our flagship product, CARTISTEM, is the world's first allogeneic stem cell therapy for...

  • Associate II, Cell Therapy Manufacturing

    4 weeks ago

    Cambridge, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty...

  • Associate I, Cell Therapy Manufacturing

    4 weeks ago

    Cambridge, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty...

  • Associate I, Cell Therapy Manufacturing

    3 weeks ago

    cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to...

  • Associate I, Cell Therapy Manufacturing

    3 weeks ago

    cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to...

  • Associate I, Cell Therapy Manufacturing

    4 weeks ago

    Cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to...

  • Associate I, Cell Therapy Manufacturing

    4 weeks ago

    Cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to...

  • Quality Systems Lead

    54 minutes ago

    cambridge, United States MEDIPOST America, Inc. Full time

    MEDIPOST is Korea’s largest and most trusted umbilical cord blood bank and a commercial-stage cell therapy company. We develop novel umbilical cord-derived stem cell therapies to treat degenerative diseases like Alzheimer’s, Diabetic Neuropathy, and Osteoarthritis.Our flagship product, CARTISTEM, is the world's first allogeneic stem cell therapy for...

  • Analytical Development Group Leader

    3 weeks ago

    Cambridge, Massachusetts, United States Adaptimmune Full time

    Job SummaryWe are seeking an experienced Analytical Development Group Leader to join our Process and Analytical Development team at Adaptimmune. As a subject matter expert in analytical assays development, you will lead early-stage and late-stage analytical assays development/optimization and tech transfer of release and characterization testing for clinical...

  • Lead, Manufacturing Training

    4 weeks ago

    Cambridge, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty...

  • Director of Analytical Development

    2 months ago

    Cambridge, United States Apex Systems Full time

    Job#: 2031855 Job Description: Location:  Greater Boston, MA (Onsite) Science/ Focus : Cell Therapy Job Overview: The Director of Analytical Development will lead the creation and execution of strategies for high-throughput, high-quality testing of iPSC Cell Therapy products, developing analytical methods and streamline method development and...

  • Associate Scientist, Cell Therapy

    2 weeks ago

    Cambridge, United States Intellia Therapeutics Full time

    Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...

Lead, Cell Therapy Manufacturing

4 months ago

Cambridge, United States Vericel Corporation Full time
Job DescriptionJob Description

POSITION SUMMARY

Under Manufacturing management guidance, the Manufacturing Team Lead I or II is responsible for oversight of manufacturing activities in the cleanroom for cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform aseptic manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs, and Safety regulations.
  • Maintain frequent communication with Supervisor to exchange information, recommendations and to review daily cleanroom activities.
  • Under Management guidance, provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands.
  • Provide guidance to staff consistent with cGMP and corporate quality governance.
  • Serve as a liaison between employees and Management.
  • Observe for process consistency within the team and report any observations to Management when problems occur. Receive guidance from Management regarding remediation.
  • Serve as a technical resource for questions and/or investigate manufacturing issues.

Additional Responsibilities:

  • Serve as a Qualified Trainer and assist with staff training.
  • Assist Management with monitoring the staff and workload to meet or exceed productivity performance standards.
  • Recommend ideas for improvement in work practices.
  • Assist technicians with EBR issues and provide technical guidance.
  • May provide input for the development of manufacturing policies (including operational, safety and quality programs).
  • Perform tasks in Manufacturing software systems (e.g., sales order entries, confirming Preactor inventory and setting schedules including changes, GP entry and verification of process work, etc.).
  • May learn the Preactor scheduling system and function as a backup Scheduler.
  • May assist Management with coaching and mentoring of staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
  • Assist Management by offering feedback for annual performance reviews and provide ongoing input based on established goals.
  • Perform activities within TeamShare (e.g., workflows, periodic reviews, etc.),
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Biotechnology Certificate with 2+ years of experience (Lead I) or 4+ years of experience (Lead II) working in a cGMP environment in the biotech or pharmaceutical industry.
  • Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).

Preferred Qualifications:

  • Bachelor’s Degree (Life Sciences or related field) or equivalent
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
  • Qualified as an On the Job Trainer.
  • Excellent communication skills, written and verbal.

WORKING CONDITIONS AND PHYSICAL DEMANDS ☐ N/A

  • May be required to sit for long periods of time while performing cell culture operations.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Ability to work 1 weekend day.
  • Rotating holiday coverage.
  • Ability to gown and gain entry to manufacturing areas