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Career Opportunities

Our mission has the potential to transform lives. Our team is a dedicated group of exceptionally talented and experienced individuals who are committed to teamwork and excellence, and who share our focus on and responsibility to patients. If you want to join a company whose culture fosters growth, innovation and collaboration, and whose breakthroughs can lead to profound value to society, please contact us at careers@tengion.com. Tengion is an equal opportunity employer.

Research Associate, Clinical Manufacturing

Department: Manufacturing

Reports To: Senior Director, Manufacturing and Process Development

FLSA Status: Full-Time / Exempt

Contact: careers@tengion.com

SUMMARY

The Research Associate, Clinical manufacturing is responsible for conducting activities related to manufacturing of Tengion products for pre-clinical and Phase I-II clinical trials.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Perform processing for the production of neo-tissues and neo-organs for pre-clinical animal studies and early stage human clinical trials
  • Adherence to Good Manufacturing Practices and standard operating procedures, completes production records and maintains clean room environment to comply with regulatory requirements
  • Perform facility maintenance, including cleaning and disinfection of cleanroom areas, manufacturing materials and equipment
  • Execute experimental protocols for on-going development of clinical processes; identify potential risks and formulate experiments to investigate process variation.

SUPERVISORY RESPONSIBILITIES

None

QUALIFICATIONS

  • Associate or Bachelor Degree in a technical discipline
  • 0 to 2 Years of practical experience in a process development or GMP manufacturing environment
  • Possess a solid background in either cell culture processes or tissue engineering
  • Experience in aseptic bio-processing and cell propagation technologies desired
  • Solid understanding of cGMPs and cGTPs preferred
  • Strong communication skills, both verbal and written
  • Good computer skills

EDUCATION and/or EXPERIENCE

  • Associate or Bachelor Degree in a technical discipline
  • 0 to 2 Years of practical experience in a process development or GMP manufacturing

TECHNICAL SKILLS

  • Possess a solid background in either cell culture processes or tissue engineering
  • Experience in aseptic bio-processing and cell propagation technologies desired
  • Solid understanding of cGMPs and cGTPs preferred
  • Strong communication skills, both verbal and written
  • Good computer skills

LANGUAGE SKILLS

Ability to read, analyze, and interpret documents specific to the job. Ability to effectively communicate with peers and upper executive level management and customers

MATHEMATICAL SKILLS

As required

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions

Please submit cover letter and resume to careers@tengion.com.

 

Research Associate / Sr. Research Associate, Biomaterials Development

Department: Bioprocess Research and Development

Reports To: Director, Biomaterials Development

FLSA Status: Full-Time / Exempt

Contact: careers@tengion.com

SUMMARY

The Research Associate / Sr. Research Associate position in Biomaterials Development will focus on developing biomaterials and evaluating cell / biomaterial interactions for Tengion’s biomaterial based products. The appropriate candidate will have a BS or MS in Bioengineering/Biomedical Engineering and 3-5 years’ experience in biomaterial design and characterization of mammalian cells seeded onto or within biomaterial scaffolds.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Working with cross-functional teams to design and develop new biomaterials
  • Characterization of biomaterials through physical, mechanical and functional
  • Evaluating cell / biomaterial interactions, including phenotypic expression
  • Assisting in the development of in vitro and in vivo assays/protocols for the evaluation of cell to biomaterial interaction
  • Preparation of biomaterials for preclinical testing
  • Performing product release of biomaterials maintaining GLP and GMP guidelines
  • Writing developmental reports and SOPs

SUPERVISORY RESPONSIBILITIES

None

EDUCATION and/or EXPERIENCE

  • BS or MS in Biological Sciences, Biomedical Engineering, Chemical Engineering or related discipline
  • 3-5 years’ experience in the field of tissue engineering or related disciplines

TECHNICAL SKILLS

  • Working knowledge of Good Laboratory Practices (GLP)
  • Experience with development and optimization of biomaterials for regenerative medicine
  • Experience with design, fabrication and optimization of biomaterial scaffolding, including natural and synthetic polymers
  • Experience with mammalian cell culture
  • A solid working knowledge of techniques to characterize biomaterials and cell / biomaterial interactions
  • Must possess strong interpersonal and verbal/written communication skills and work well as part of a team
  • Must demonstrate good record keeping and problem solving skills while meeting project timelines

LANGUAGE SKILLS

Ability to read, analyze, and interpret documents, graphs, journal articles, etc. Ability to effectively communicate, in both written and verbal form, with peers, management, vendors, etc.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Please submit cover letter and resume to careers@tengion.com.

 

Sr. Scientist / Director, Device Development

Department: Bioprocess Research and Development

Reports To: CTO, SVP, BPRD and Technical Operations

FLSA Status: Full-Time / Exempt

Contact: careers@tengion.com

SUMMARY

The Sr. Scientist/Director of Device Development is responsible for overseeing all activities related to development of devices and establishment of manufacturing/sourcing devices used in pre-clinical and clinical trials. This position is also responsible in coordinating technology transfer activities between the BPRD and Technical Operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Lead efforts to identify and efficiently establish Device Development in the area of tissue engineering and regenerative medicine including but not limited to establishment of devices used in genitourinary and renal applications.
  • Responsible for providing technical expertise to device development and product engineering programs including but not limited to delivery and implantation of engineered tissues.
  • Contribute to strategic decision making for device development and for regulatory, clinical and commercial pathways.
  • Responsible for regulatory approval pathways for devices including 510k, PMA and other routes.
  • Lead efforts towards implementation of devices for clinical studies and commercial production.
  • Provide guidance, encouragement, and opportunity personnel in the group to pursue scientific questions relevant to the mission of the company.
  • Attract, develop, and retain experienced and motivated scientific staff in the area of tissue engineering and device development.
  • Through strong leadership, ensure that the Device Development group works seamlessly with other departments within BPRD and with Technical Operations groups to transfer devices that are robust, scalable, and efficient for commercial applications.
  • Participate in the development of quality and manufacturing specifications for GLP/GMP, including criteria to initiate first human studies and early manufacturing
  • Develop scientific, governmental, other relationships that will support the rapid commercialization of healthy and durable engineered organs specifically designed for innovations in medical care

Budgetary levels will be assigned according to the level of this position. Other duties may be assigned as needed

SUPERVISORY RESPONSIBILITIES

This position may oversee both engineers and scientists ranging from Bachelors of Science or engineering to advanced degrees (PhD or equivalent). This position will be responsible for interviewing, hiring, training, planning, assigning, & directing work and will provide the appropriate appraisals, rewards, discipline, etc. as required for the position.

QUALIFICATIONS

  • Ph.D. in Biomechanical Engineering or equivalent degree / discipline
  • Minimum 10 years’ experience in the field of tissue engineering or related disciplines
  • Hands-on experience implementing device development, engineering of devices and cell delivery systems
  • Experience interacting with the FDA (CBER and/or CDRH)
  • Experience designing and conducting tests and protocols for device functionality
  • Experience in regulatory safety and durability testing and registration
  • Knowledge of, and contacts in, relevant scientific and trade organizations and regulatory agencies
  • Strong interpersonal and communication skills
  • Ability to manage multiple projects and function in an environment of changing priorities and directions
  • Have supervisory and managerial experience

EDUCATION and/or EXPERIENCE

  • Ph.D. in Biomechanical Engineering or equivalent degree / discipline
  • Minimum 10 years’ experience in the field of tissue engineering or related disciplines

TECHNICAL SKILLS

  • Hands-on experience implementing device development, engineering of devices and cell delivery systems
  • Experience interacting with the FDA (CBER and/or CDRH)
  • Experience designing and conducting tests and protocols for device functionality
  • Experience in regulatory safety and durability testing and registration
  • Knowledge of, and contacts in, relevant scientific and trade organizations and regulatory agencies
  • Strong interpersonal and communication skills
  • Ability to manage multiple projects and function in an environment of changing priorities and directions
  • Have supervisory and managerial experience

LANGUAGE SKILLS

Ability to read, analyze, and interpret documents specific to the job. Ability to effectively communicate with peers and upper executive level management and customers

MATHEMATICAL SKILLS

As required

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions

Please submit cover letter and resume to careers@tengion.com.

 

Scientist/Director, Process Development

Department: Bioprocess Research and Development

Reports To: CTO, SVP, BPRD and Technical Operations

FLSA Status: Full-Time / Exempt

Contact: careers@tengion.com

SUMMARY

The Director of Process Development is responsible for overseeing all activities related to process development and establishment of manufacturing processes performed for pre-clinical and clinical trials. This position is also responsible in coordinating technology transfer activities between the BPRD and Technical Operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Lead efforts to identify and efficiently establish Process Development in the area of tissue engineering and regenerative medicine including but not limited to establishment of processes for construction for genitourinary and renal products.
  • Responsible for providing technical expertise to process development and product engineering programs including but not limited to bioprocessing of engineered tissues.
  • Contribute to strategic decision making for product and process development and for regulatory, clinical and commercial pathways.
  • Lead efforts towards development of processes for the production of GMP materials for clinical studies and commercial production.
  • Provide guidance, encouragement, and opportunity personnel in the group to pursue scientific questions relevant to the mission of the company.
  • Attract, develop, and retain experienced and motivated scientific staff in the area of tissue engineering and process development.
  • Through strong leadership, ensure that the Process Development group works seamlessly with other departments within BPRD and with Technical Operations groups to transfer production processes that are robust, scalable, and efficient for commercial manufacturing.
  • Participate in the development of quality and manufacturing specifications for GLP/GMP, including criteria to initiate first human studies and early manufacturing
  • Develop scientific, governmental, other relationships that will support the rapid commercialization of healthy and durable engineered organs specifically designed for innovations in medical care
  • Assist in the transition and validation of late-stage research technology, including biomaterials, scaffolds and organ engineering, from research laboratories to early manufacturing and development stages

Budgetary levels will be assigned according to the level of this position. Other duties may be assigned as needed.

SUPERVISORY RESPONSIBILITIES

This position may oversee both engineers and scientists ranging from Bachelors of Science or engineering to advanced degrees (PhD or equivalent). This position will be responsible for interviewing, hiring, training, planning, assigning, & directing work and will provide the appropriate appraisals, rewards, discipline, etc. as required for the position.

QUALIFICATIONS

  • Ph.D. in Biochemical Engineering or equivalent degree / discipline
  • Minimum 10 years’ experience in the field of tissue engineering or related disciplines
  • Hands-on experience implementing cell-based process development, engineering of cell-based bioreactors and technology transfer into manufacturing
  • Experience interacting with the FDA (CBER and/or CDRH)
  • Experience designing and conducting tests and protocols for product functionality
  • Experience in regulatory safety and durability testing and registration
  • Knowledge of, and contacts in, relevant scientific and trade organizations and regulatory agencies
  • Strong interpersonal and communication skills
  • Ability to manage multiple projects and function in an environment of changing priorities and directions
  • Have supervisory and managerial experience

Please submit cover letter and resume to careers@tengion.com.