Job Summary

• Review batch-related documentation and ensure resolution of issues to ensure timely release of final product.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Work with Manufacturing, Clinical Development and Quality Control, as area Quality Assurance (QA) representative.
• Own and/or approve change controls to manage new materials and material changes.
• Develop and assist in maintaining the audit schedule and approved supplier list for assigned suppliers.
• Perform ongoing evaluation of quality systems, that include but are not limited to, the quality audit program, vendor qualification system & the corrective action program.
• Support inspection readiness plans and interact with regulatory agencies during inspections on quality related matters, as needed.
• Perform other duties as assigned.

General Accountabilities

• Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
• Generates COAs for product release.
• Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practices.

• Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
• Work in clean room environment that requires specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers.
• Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria.
• Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
• Handle human blood and human blood base product.
• Other duties as assigned.

Job Qualifications

• Education: Bachelor’s degree in biochemistry or related biological field and minimum of 3-5 years progressive experience in a pharmaceutical, biotechnology, or biologics operation and/or equivalent education/work experience. Master’s degree in a related science for a minimum of 4 + years highly preferred.
• Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, and CAPA as well as with internal and external audits.
• Working knowledge of and ability to apply Good Manufacturing Practice (GMP) in conformance to US FDA standards.
• Highly detail oriented and excellent interpersonal skills within collaborative work environment.
• If required, ability to work on weekend, off-shift and long hours.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Strict adherence to SOP’s and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing.
• Self-motivated and willing to accept responsibilities outside of initial job description.
• Ability to lift over 30lbs.

Skills

• Excellent technical skills; Microsoft Word, Excel and Data Analysis.
• Exceptional time management, problem solving and organization skills.
• Outstanding interpersonal skills, verbal and written communication, in collaborative work environment setting.

Job Summary

This role is to perform analytical testing in a cGMP environment

General Accountabilities

This position is responsible for the following:

• Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete testing in a timely and appropriate manner.
• May maintain inventory/supplies necessary to conduct routine testing
• Performs equipment maintenance and calibrations as required.
• Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
• Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
• Investigate and write exception (e.g. deviations and OOS) documents.
• May perform other duties as assigned.

Job Qualifications and Skills:

• Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.
• Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
• Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
• Experience with setting up and successfully managing cell-based assays is highly preferred.
• Education, training, or experience in cell therapy a plus.
• Proficient in MS Office, Visio, Project, and statistical software.
• Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S.
• CELL CULTURE EXPERIENCE A MUST