Manufacturing Training Specialist

Proclinical is seeking to hire a Manufacturing Training Specialist located in Philadelphia, PA. This individual will be a trainer for the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.

Job Responsibilities:

• Assist in the development and/or review developed training
• Support management with the alignment of manufacturing processes with technical training and ensure consistent alignment between the processes.
• Identify trends and update training as necessary
• Develop a comprehensive understanding of current cell therapy manufacturing process, as this role is viewed as a subject matter expert within specific area.
• Deliver training sessions and ensure training documentation is Ensure training schedules meet company production and quality targets.
• Assists with identification of training needs, establishing a feedback loop to ensure continuous improvement, and using key performance indicators to measure training effectiveness.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Required to support cleanroom operations on a frequent
• Supports technical transfer and additional research level testing
• 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.
• Supports documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Troubleshoot unexpected results, prioritize workload and solve moderately complex
• Ability to work in a team environment and independently as Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review documentation of functions performed as part of quality control Review data as generated/collected by less experienced technical staff.
• Contribute to department operations improvement in areas such as SOP revisions and department
• Other duties as

Skills and Requirements:

• Minimum bachelor's degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• Minimum of 5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing. Cell therapy experience
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a
• Strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture processing.
• Experience leading "development" initiatives, e., training, coaching, learning initiatives.
• Ability to mentor and provide best practices to other members of the
• Ability to build relationships quickly and Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment (potentially 50+ employees) representing a variety of personalities and experience levels.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric 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
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA
• Excellent presentation skills, both written and
• Understands and complies with quality standards and requirements as
• Must have strong written and verbal communication and organizational
• Strong computer skills, problem solving and attention to
• Familiarity with data and sample management required (LIMS/MES)
• Able to work independently with minimal
• Must adhere to the companies core values, policies, procedures and business
• Trainer is required to work the assigned schedule. This position is currently for regular work week hours (1st shift M-F); however, due to the nature of cell therapy manufacturing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as It is also expected that regular work weeks may change once commercial manufacturing commences and may involve shift changes (i.e. Tuesday to Saturday). May be required to work overtime.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• Must be able to work in environment with variable noise levels
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), e. scrubs, gowning coverall, masks, gloves, etc.
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
• Ability to stand/sit/walk for long periods of time
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
• Ability to lift 20 lbs

If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at (+1) 617-671-0335 or s.jankura@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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