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Senior Development Technologist Ad id: 2307133574461006 |  Views: 90

Price: Contact Us
Date listed: 5 years ago
Opexa Therapeutics, Inc. isa leading biotechnology company that develops personalized cellular therapies to treat multiple sclerosis, rheumatoid arthritis, pancreatic, and cardiac conditions. Their leading therapy candidate includes Tcelna, a patient-specific T-cell immunotherapy, which is currently in Phase IIb clinical development for the treatment of patients with Secondary Progressive MS.   Due to continued growth, we are looking for a Senior Development Technologistto join our team in The Woodland, TX.   Some of the benefits of this exceptional opportunity are: Stability–Founded in 2004 through the merger of two independent companies, Opexa Therapeutics, Inc. is at the forefront of cell therapy technology where it remains a leading force today and its primary platform of T-Cell Technology can be used around several auto immune innovations.   Career Growth– In this critical and highly visible role, you will be the lead technologist working with a team of scientist to plan and execute process development plans and evaluated automatable technology platforms.  You will be able to grow with a company as they enter new ground-breaking technologies in the betterment of human health.   Make a Positive Impact – Opexa Therapeutics mission is to lead the field of Precision Immunotherapy™ by aligning the interests of patients, employees and shareholders. There are so few drugs on the market that treat MS effectively that Tcelna is taken as a serious option and as a result the FDA has sanctioned fast-track approval of the drug pending the outcome of the studies. You will be helping millions of people get the personalize treatment needed to improve their quality of life.   Compensation – Opexa Therapeuticsoffers a very competitive compensation and benefits package including Medical, Dental and Vision.   General purpose The Senior Development Technologist   will work under the guidance of the Director of Manufacturing and Process Development  to coordinate and perform assigned responsibilities to support the Company’s product manufacturing process improvement initiatives.  The Senior Development Technologist will also participate in the evaluation process of new technologies and its applicability to the product manufacturing process.  Essential to this role is the ability to contribute technical expertise to the manufacturing process while optimizing process performance and quality.  The demands of this role command strong direct experience and a thorough understanding of GMP techniques and modern manufacturing methodologies. The Senior Development Technologist will collaborate closely with Research & Development, Manufacturing, Quality Control and Quality Assurance associates for the coordination of laboratory equipment and people resources to execute on the assigned development projects. To support the Company's vision, mission, and values by demonstrating: excellence and competence, collaboration, innovation, respect, commitment to our community, and accountability. Duties and responsibilities Primary duties and responsibilities of this role include the following. Other related duties may be assigned to meet business needs. Work as part of a multidisciplinary project team to develop innovative technology and process improvements. Coordinate the activities of the process development team in the optimization, scale up, and scale out of the manufacturing process; Evaluation of new techniques and technologies; and Active participation in the assessment of the Company’s technology platform to new disease indications. Responsible for the experiment, design and execution of the planned work, data analysis and interpretation, and  presentations. Provide regular updates, documentation and communication of project results; Demonstrates the ability to correctly analyze and interpret outcomes of experiments and report data;. Communicates own work orally and in writing and provides input for scientific reports; and Reports and treats data with a high level of integrity and ethics. Demonstrate ability to define, investigate and solve complex problems using diverse established and experimental procedures. Implement and maintain procedures to ensure compliance with company quality system, safety systems and technical excellence. Maintaining comprehensive records of all work and write and review formal reports; Provides the data in a quality presentation form (graphs, figures, tables, etc.) to support regulatory submissions and peer-reviewed publications; and Generates and maintains necessary batch records, SOPs, EOPs, and process control forms in accordance with company policies. Contribute to project teams through lab-based activities. Coordinate and perform the technical transfer of knowledge, procedures, process improvements and techniques to manufacturing personnel and other appropriate departments. Other research and development tasks as assigned. Supervisory duties While this position has no supervisory responsibilities, the Senior Development Technologist may be required to participate in various leadership activities including interviewing, orienting and training new employees, as well as planning, assigning and assessing work of department staff. Minimum qualifications The following are the minimum qualifications and competencies that an individual needs in order to successfully perform the duties and responsibilities of this position. The individual may be required to demonstrate proficiency in some of these depending on the department and/ or job functions assigned. General and technical Demonstrate technical ability to carry out the execution of non-routine experiments and procedures with little or no direct supervision. Experience working in a matrix environment to effectively collaborate with other functional departments  and associates  while driving  and embracing new ideas and concepts. Demonstrated ability to work collaboratively as a member of a project team and to communicate effectively with colleagues. Strong working knowledge of GTP, GMP, and GLP guidelines, including direct experience in GMP manufacturing and/or process improvement in the Biotech/Pharmaceutical industries. Strong working knowledge of the science and technical aspects of T-cell culture. Excellent problem solving ability and understanding of manufacturing processes. Ability to work well under pressure and meet critical timelines. Strong and effective oral and written communication skills. Demonstrated knowledge and application of pertinent or comparable computer programs, as well as working knowledge of MS Office programs (e.g. Excel, Word). Education, training and experience Minimum 3 years of experience in the implementation of process development and/or manufacturing of cellular based products. Bachelor’s Degree with a medical technology or blood banking discipline is desirable.  A college degree in a scientific discipline in conjunction with relevant working experience is also acceptable. Core competencies Analytical—fuses intricate or diverse information. Judgment—exhibits sound judgment and makes timely decisions. Planning/organizing—prioritizes and plans work activities, uses time efficiently and develops realistic action plans. Problem solving—identifies and resolves issues in a timely manner, gathers and evaluates information competently. Oral communication—speaks clearly and persuasively in positive or negative circumstances, demonstrates group presentation skills and leads meetings. Quality control—demonstrates accuracy and attention to detail, examines own work to ensure excellence and applies feedback to improve performance.   Physical demands In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to allow differently-able individuals to perform the essential functions of the job. Manual dexterity required for occasional reaching and lifting of small objects, and operating office equipment. Work environment In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to allow differently-able individuals to perform the essential functions of the job within the environment. The office is clean, orderly, properly lighted and ventilated.  Noise levels are considered low to moderate. You owe it to yourself to check this out! This is a great opportunity to use your experience to use your skill and expertise in an environment helps millions of people.       Opexa Therapeutics, Inc. is an Equal Opportunity Employer. Workrocket.com provides a fast and effective way to connect with great technician jobs. We work with a wide range of companies that offer excellent career opportunities. The industries we serve range from heavy construction equipment to HVAC to medical and surgical equipment just to name a few. Connecting Job seekers with great technician jobs is what we do. http://www.workrocket.com Compensation: Based on ExperiencePrincipals only. Recruiters, please don't contact this job poster.Please do not contact job poster about other services, products or commercial interests.
 


 
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