Training Specialist

Overview We are seeking a Training Specialist I to join the Operations team. The lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required. Essential Functions and Responsibilities Develops a basic understanding of the current cell therapy manufacturing process and the equipment utilized during processing, as this role is viewed as a subject matter expert (SME) within this specific area. Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements; Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. Presents and delivers content to manufacturing technicians. Assists with the creation, review and improvement of designated training scripts; On the Job and Instructor Led Trainings (OJTs and ILTs). Supports management with the alignment of manufacturing processes with technical training, ensuring consistency. Helps to identify training needs; assists in establishing a feedback loop to ensure continuous improvement. Assists with drafting SOPs, Batch Records, Deviations, CAPAs, etc. Performs revisions as needed to accurately reflect current procedures. Appropriately escalates issues/concerns to Area Management for further investigation. Works on assignments that are moderately complex in nature, where judgement is required to resolve or escalate operational issues without negatively impacting manufacturing efforts. Troubleshoots unexpected results, prioritizes workload and solves moderately complex problems. Possesses ability to work in a team environment or independently, as needed. Must adhere to the Company's core values, policies, procedures and business ethics. Complies with Safety SOPs, SDS sheets and laboratory procedures per company policy and OSHA regulations. Performs miscellaneous duties as assigned. Required Education, Skills, and Knowledge: Minimum bachelor's degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Technical knowledge of aseptic processing in cleanroom environments is a must. Knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning and qualification is a must. Experience leading "development" initiatives such as training, coaching/mentoring, learning initiatives. Ability to mentor and provide best practices to new employees. Ability to build relationships quickly and provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment, representing a variety of personalities and experience levels. Ability to accurately and reproducibly perform arithmetic calculations including decimals, percentages and basic algebraic calculations. Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment. Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change. Ability to work successfully in a fast-paced team-oriented setting. Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations. Excellent presentation skills, both written and verbal. Understands and complies with quality standards and requirements as documented. Must have strong written and verbal communication and organizational skills. Strong computer skills, problem solving and attention to detail. Familiarity with data and sample management required (LIMS/MES). Working knowledge within a Learning Management System (LMS). Able to work independently with minimal supervision. Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook). Preferred Education, Skills and Knowledge: Experience with cell and gene therapy. Experience with Master Control. Physical Demands and Activities Required: The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety goggles, etc. Must meet requirements for and be able to wear a half-face respirator. Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors; may be given a visual exam for visual acuity and color perception. Ability to stand and/or walk 90% (and sit 10%) within your scheduled workday. Ability to crouch, bend, twist, reach, and perform activities with repetitive motions. Must be able to lift and carry objects weighing 25 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion. Ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment: This position will work in both an office environment and a manufacturing lab setting. Must be able to work in laboratory setting with various chemical/biochemical exposures, including latex and bleach. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors. Must be able to work in environment with variable noise levels. The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.