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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 rapidly growing 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.


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Bioprocess Research and Development

Business Development and Marketing Planning

Technical Operations

 

Bioprocess Research and Development

Position: Research Associate, Bioanalytical
Location: Winston Salem, NC
Employee Status: Full-time, Regular

Responsibilities for this position include:

  • Support the analytical testing, method development and transfer across a wide range of technology platforms
  • Support routine laboratory systems and operations, including cell line maintenance
  • Serve in assay leader role including acting as point person for training, assay performance monitoring, troubleshooting and failure investigations
  • Work with immunocytochemistry, FACS analysis, ELISA, PCR, HPLC and other cell-based assays
  • Support biological activity assays for product release/stability testing of various pipeline programs
  • Author SOPs, qualification/validation protocols and reports
  • Take key role in transfers of assays/technologies to Service Groups and Quality Control Department for routine performance
  • Train/mentor new associates on assays and laboratory procedures

Requirements:

  • Bachelor or Master degree in Cell Biology, Biochemistry or related scientific discipline
  • Minimum 3 - 5 years of relevant experience in a cGMP regulated bioanalytical laboratory/environment
  • Aseptic techniques and cell culture experience required
  • Extensive hands-on experience in development and qualification of in vitro and cell-based assays
  • Strong interpersonal / leadership skills
  • Proven laboratory, computer, documentation/writing, organizational and record-keeping skills
  • Excellent communication skills and ability to collaborate in a team environment
  • Candidate must be flexible and able to adapt to changing project priorities and timelines
  • Understand and help develop strategies and techniques to address biological questions in molecular biology, cell biology, and biochemistry

 

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Position: Research Associate, Cell Culture
Location: Winston Salem, NC
Employee Status: Full-time, Regular

Responsibilities for this position include:

  • Execute experiments aimed at isolating, characterizing, and propagating primary renal cells and cell population(s) from mammalian kidney tissue. These experiments will include, but not be limited to:
    • Tissue dissociation and establishment of primary kidney cultures
    • Application of cells to biomaterials and evaluation of cell performance and phenotype in three-dimensional systems
    • FACS-based and immunocytochemistry-based characterization of cultured cells
    • MACS-based purification of cell subpopulations
    • Development and execution of bioassays for identification of secreted, biologically active proteins
    • Comparative studies of in vitro growth conditions on renal cell cultures
  • Establish and document detailed research protocols for all isolation, culture, and characterization procedures related to the renal program
  • Provide weekly and ad-hoc updates of ongoing experiments and results to RegenMed team

Requirements:

  • B.S. degree and 2+ years of experience in cell biology / medicine-related field
  • Strong organizational skills with a clear track record of setting and adhering to priorities
  • Strong oral and written communication skills
  • Strong interpersonal skills
  • Fluid computer skills, including Microsoft Office, and electronic document management capabilities
  • Must be able to work through change fluidly in a highly dynamic environment
  • Must be willing to work flexibly to accommodate delivery and processing of critical samples in a timely manner

 

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Position: Senior Scientist, Biomedical Engineer
Location: Winston Salem, NC
Employee Status: Full-time, Regular

Responsibilities for this position include:

  • Evaluation and optimization of biomaterial processing to enhance and modulate cell behavior (attachment, viability, phenotype, function)
  • Develop and perform mechanical tests of scaffold/construct in multiple stages of maturation
  • Participate in the definition of quality and manufacturing specifications for GLP/GMP
  • Participate in the selection, design and adaptation of equipment used in pre-manufacturing and pre-human studies related to tissue engineering, cell biology and biomaterial optimization
  • Conduct cell-scaffold engineering necessary to support timely regulatory approval of Tengion's products, product extensions and post-marketing modifications
  • Develop scientific, governmental, and trade organization relationships that will benefit the Company with respect to innovations in medical care
  • Provide development personnel guidance, encouragement, and opportunity 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 biomaterials development

Requirements:

  • PhD/MS in Biomedical Engineering, Bioengineering or related disciplines
  • Minimum 5 years experience in the field of tissue engineering, ideally in vascular engineering
  • Experience with design and execution of experiments involving scaffold and tissue engineering
  • Expertise in modulation of cellular performance by biomaterials
  • Experience selecting, designing and adapting equipment used in pre-manufacturing and pre-human studies in areas of scaffold design and tissue engineering
  • Experience with evaluation, design and construction of biomaterial scaffolding, including natural and synthetic polymers
  • Experience interacting with FDA (CBER and/or CDRH)
  • Knowledge of, and contacts in, relevant scientific and trade organizations and regulatory agencies
  • Experience developing product specifications
  • Experience in regulatory safety and durability testing and registration
  • Strong interpersonal and communication skills
  • Strong verbal and writing skills
  • Ability to manage multiple projects and function in an environment of changing priorities and directions

 

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Business Development and Marketing Planning

Position: Director, Marketing Planning
Location: East Norriton, PA
Employee Status: Full-time, Regular

Responsibilities for this position include:

  • Develop commercialization plans for product pipeline and life-cycle management strategies
  • Conduct US and global product marketing evaluations
  • Lead development of pricing and reimbursement strategies and tactical plan execution
  • Manage process for publication planning
  • Develop product and company advocacy with key opinion leaders and professional societies
  • Define customer requirements for new product development projects
  • Provide detailed marketing specifications of new products or product improvements to research and development teams
  • Work cross-functionally with research, clinical, regulatory, manufacturing, and finance to identify, assess, prioritize, and specify new product pipeline opportunities to address new or expanded medical indications
  • Work with cross-functional members of product development teams to define and maintain Target Product Profiles
  • Work cross-functionally with research, clinical, regulatory, manufacturing, and finance to support product sequencing recommendations
  • Acquire and analyze market information by attending relevant medical conferences, meetings with potential thought leaders and customers, and conducting market research
  • Synthesize gathered information into actionable recommendations to Sr. Management

Requirements:

  • Bachelors Degree required.  MBA or Masters Level degree preferred
  • Minimum 5 years of progressive marketing experience in the medical device pharmaceutical or biotech industry is required
  • Deep understanding of medical, technical, and commercial aspects of product positioning against market needs and competitors is required
  • Knowledge of healthcare economic, pricing and reimbursement, clinical and regulatory development is required
  • Experience partnering with R&D teams and strong analytical skills in uncovering and analyzing problem areas/growth opportunities are required
  • Excellent and proven collaborative skills in developing relationships, leading highly matrixed, high performing, multi-functional cross-company teams
  • Proven ability to create alignment across teams from multiple, functions and geographies is required
  • Global experience is preferred
  • Must be a strong team player with highly developed planning and prioritization skills

 

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Technical Operations

Position: Senior Analytical Technology Specialist II
Location: East Norriton, PA
Employee Status: Full-time, Regular

Responsibilities for this position include:

  • Responsible for providing scientific and technical expertise for the analytical methodologies supporting Tengion’s tissue engineering/organ regeneration technologies
  • Provide support for the transfer of analytical methods to commercial site(s) and provide continuing technical support to ongoing manufacturing and quality operations at commercial sites
  • Identify and, as appropriate, develop improved analytical methods supporting process characterization & qualification and product release
  • Work with Quality to provide technical expertise to the timely trouble-shooting and resolution of technical problems encountered with analytical methods such that loss of product is avoided

Requirements:

  • Ph.D. in cell biology, biochemistry and/or related field with a minimum of 5 years industrial experience related to job duties outlined
  • Prior experience in developing and transferring analytical methods from development into commercial operations required
  • Knowledge of cGMPs, cGTPs and analytical/bioanalytical method qualification/validation practices required
  • Must have excellent technical skills and practical working knowledge of a variety of bioanalytical techniques including, but not restricted to, immunocytochemistry, flow cytometry, PCR, qPCR, RTPCR, and imaging systems and image analysis. Experience with high content analysis would be a plus. Technical skills in basic cell culture important.
  • Must possess excellent intrapersonal and communication skills

 

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Position: Senior Manufacturing Associate I
Location: East Norriton, PA
Employee Status: Full-time, Regular

Responsibilities for this position include but are not limited to:

  • Performs the manufacturing process for the production of neo-tissues and neo-organs for clinical trial and commercial use in accordance with clinical and commercial demand
  • Adheres to Good Manufacturing Practices and standard operating procedures.
  • Authors/revises Batch Production Records, complex Standard Operating Procedures (SOP’s) and Solution Preparation Records as needed to accurately reflect manufacturing processes
  • Completes production records and maintains clean room environment to comply with regulatory requirements
  • Provides leadership in the startup and validation efforts for the Manufacturing Facility and may represent Manufacturing during Factory Acceptance Testing of new equipment
  • Ensures junior manufacturing personnel comply with Standard Operating Procedures (SOP’s) and Master Production Records and that training records for junior staff are accurate and current
  • Possesses sound scientific knowledge and understanding of manufacturing processes and uses this skill set to routinely monitor manufacturing processes and recognize potential process issues as they arise
  • In conjunction with management personnel, participates in the technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures
  • Authors Adverse Events and reviews Validation reports and Master Production Records to ensure documents are accurate and complete
  • Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations
  • Works with senior manufacturing personnel to improve and optimize manufacturing methods
  • Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary
  • In the absence of the area Supervisor or manufacturing lead, may function as an area leader with respect to work assignments, technical guidance and scheduling
  • Provides training and operational guidance to junior staff and also serves to mentor junior staff in manufacturing techniques

Requirements:

  • Associate or Bachelor Degree in a Technical Discipline
  • Minimum 2 Years as a Manufacturing Associate II or Equivalent
  • Possess a solid background in either cell culture processes or tissue engineering
  • Experience in aseptic bioprocessing and cell propagation technologies required
  • Experience with primary cell culture is highly desired
  • Solid understanding of cGMPs and cGTPs preferred

 

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