Career Opportunities
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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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Read more about Our People ››
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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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