Careers

Advanced Cell Technology, Inc., a biotechnology company, engages in the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. The company is conducting various clinical trials for treating macular degeneration, and has a preclinical development pipeline focused on products for eye diseases, autoimmune and inflammatory diseases, and wound healing. Its intellectual property portfolio includes pluripotent stem cell platforms comprising embryonic stem cell and induced pluripotent stem cell (iPSC) platforms; and other cell therapy research programs, such as opthamology, autoimmune/inflammation, and platelet programs. Advanced Cell Technology, Inc. develops and maintains an intellectual property portfolio, with ownership or licensing of approximately 37 issued patents and approximately 190 patent applications pending in the field of regenerative medicine and stem cell therapy. The company is headquartered in Marlborough, Massachusetts.

Current Openings:

Clinical Trial Manager

The Clinical Trials Manager will have a leading role in the planning, co ordination and completion of the clinical development programs of Advanced Cell Technology. The role requires excellent communication, presentation skills and interpersonal skills, together with the ability to organize and motivate others. The individual must be organized and able to produce high quality work independently and work collaboratively in high-volume, deadline-driven team with excellent attention to detail. Problem solving, a bias towards action, enthusiasm, and leadership when faced with challenges are critical and required traits in addition to strategic, tactical and operational management skills in the planning and execution of the project. The individual will work closely with the Program Management, Chemistry, Manufacturing and Controls and Quality Teams to ensure excellent execution of clinical trials conduct.

The position will report to the Associate Director of Clinical Operations.

Major Duties and Responsibilities:

  • Perform feasibility analysis, country assessment, site identification, subject recruitment and study planning.
  • Facilitates in all operational activities pertaining to the execution of clinical trials.
  • Coordinate trial-related activities including monitoring visits, site qualification, site initiation, monitoring and site-closure visits.

  • Responsible for overall study project management of clinical studies including
    • Projection and management of study timelines
    • Creation and management of clinical trial budgets
    • Ensures timely reporting of suitable Study Metrics to management
  • Establishes and maintains frequent and regular contact with investigators (written, verbal and, as needed, in person), vendors and study sites to ensure GCP/ICH/protocol compliance and assessment of accrual rates.
  • Ensures site compliance with study protocols; works proactively with CRAs and site personnel to prevent, address and resolve issues in a timely fashion.
  • Conduct co-monitoring visits to assess both site compliance and monitor CRA performance.
  • May also be required to visit clinical sites to establish direct company contact with investigators and their study personnel.
  • Ensures efficient site start-up activities (e.g. site selection/qualification, review of regulatory documents, site communication plans).
  • Review of monitoring reports and follow up letters.
  • Ensure reporting of high quality data and timely query resolution.
  • Ongoing communication and oversight of contract monitors and contract research organizations.
  • Recruitment, retention, training, appraisal and supervision of trial team members including consultants and contractors as required.
  • Establishment of procedures to ensure adherence to trial protocols and administrative requirements.
  • Ensuring the timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective data management.
  • Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
  • Management of the trial budget(s) and maintenance of the accounts.
  • Act as the point of contact for all trial-related personnel and institutions.
  • Co ordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.
  • Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and co-ordinating any necessary audit processes.
  • Liaison with the Trials Steering Committee and Data Monitoring Safety Board with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
  • Provision of regular and ad hoc information, both written and verbal, to the Project Team and all the trial participants including reports (e.g. feasibility, interim monitoring, site status, enrolment status), updates, guidance and risks.
  • Work with the Principal Investigator and site study team to ensure that the trial is meeting its milestones, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
  • Planning and supporting the meetings and work of the various groups and bodies associated with the trial.
  • Creation and maintenance of all trial files, including the trial master file, and oversight of site files.
  • Assurance that personal and confidential information is restricted to those entitled to know.
  • Participate in the authoring of Clinical Development Standard Operating Procedures and Work Instructions.
  • Extends passion and team commitment to Clinical Development initiatives.

Job Complexity:

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Networks with senior internal and external personnel in area of expertise.

Requirements:

  • BS/BA degree in related discipline and eight years of related experience; or,
  • Advanced degree in related discipline and six years of related experience; or,
  • Equivalent combination of education and experience.

Knowledge/Skills/Abilities:

  • Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and the EU.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, trial timelines, site selection, and clinical supplies management.
  • Organizes and prioritizes numerous tasks and completes them under time constraints.
  • Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques.
  • Resolves a wide range of issues in creative ways.

To Apply:
Please email resume with detailed description of background to: careers@advancedcell.com.





Manager of Cell Manufacturing

The Manager of Manufacturing is an integral part of the manufacturing team that is responsible for leading the group in the production of cell products for clinical trials. This individual should be accustomed to following SOP’s and cGMP in a clean room environment. A working knowledge of culture of embryonic stem cells and their differentiation is a must.

The work will focus on both existing clinical trial material manufacturing processes as well as new processes under development. Knowledge of technology transfer and process development of protocols into clean room SOP’s and cGMP is a plus.

Major Duties and Responsibilities:

  • Excellent cell culture and sterile technique
  • Experience working in a clean room environment
  • Understanding of cGMPs and ability to follow and adhere to SOPs
  • Strong understanding of developmental biology
  • Experience with hematopoietic stem cells and mesenchymal stem cells
  • In vitro culture and differentiation of pluripotent stem cells
  • In vitro differentiation, expansion and terminal maturation of stem cells
  • Excellent communication skills and the ability to work in a team oriented environment

Requirements:

  • BS in a related discipline with 5-8 years of relevant working experience.
  • Clean room experience
  • Have lawful immigration status to work legally for US firms

To Apply:

Please, email resume with detailed description of research background and technical skills that meet the requirements, and a list of publications to: careers@advancedcell.com.





Cell Culture Technician
The Cell Culture Technician is an integral part of the manufacturing team. This individual should be accustomed to following SOP’s and cGMP in a clean room environment and will perform daily laboratory tasks and interpret data related to cell culture and media preparation. A working knowledge of culture of hES / iPS and their differentiation is a plus.

Major Duties and Responsibilities:

  • Perform laboratory techniques and activities to generate and maintain multiple hES / iPS cell lines
  • Prepare reagents and tests samples.
  • Prepare media.
  • Write routine reports and correspondence.
  • Work within class 10,000 clean room environments while appropriately gowned.
  • Work within a class 100 biosafety cabinet to maintain sterile aseptic environment.
  • Assist in performing technical reviews of cell line paperwork.
  • Perform all other related duties as assigned.

Requirements:

  • Bachelor’s degree or equivalent in biology or related discipline.
  • 1 to 2 years industry related experience in a biological laboratory
  • Have lawful immigration status to work legally for US firms

To Apply:

Please, email resume with detailed description of research background and technical skills that meet the requirements, and a list of publications to: careers@advancedcell.com.





Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. We are an Equal Opportunity Employer.