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Hours: 6:30am - 3:00pm (Monday to Friday) We are looking for a Process Development Associate to join our team. In this role, you will support the creation and transfer of manufacturing processes from R&D to manufacturing while ensuring compliance with Good Manufacturing Practices (GMP). The ideal candidate will have a solid understanding of manufacturing processes and laboratory operations, with experience in process development and process validation.
Performs review of documents, records and procedures supporting release of clinical and commercial GMP products and participates in development of GMP operations, as assigned. Performs review of validation documentation, periodic reviews of validated systems, and/or procedures, as assigned.
You will be part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Biotherapeutics portfolio. Your initial focus will be as part of the manufacturing team focused on mammalian bio-processing. This includes and not limited to supporting the manufacturing operations team, reviewing Standard Operating Procedures, reviewing batch records, and standard work. As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing of previously acquired knowledge. It is your hard work and focus that will help in making ready to achieve new milestones and help patients across the globe.
Performs a variety of support functions to support the department. Handles multiple projects and may assist in compiling data and generating reports. Requires 1-4 years of experience in the field or in a related area. Familiar with standard concepts, practices, and procedures within a particular field. Location: Position is hybrid with the requirement to be in the office 1x per week on Wednesdays. It can be located near the office, but there is a strong preference that the candidate be local to the Houston/Kinder Morgan location.
This person’s primary responsibilities will include coordinating pre-employment compliance with Department of Transportation (DOT) and Federal Aviation Administration (FAA) regulations for records check paperwork and drug testing. The position will require someone with a strong aptitude for organization and attention to detail.
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