September 21, 2016

Formulation Lab, Lead Technician, Drug Product Development

Celgene - Summit, NJ

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  • Company
    Celgene Celgene
  • Location
    Summit, NJ
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Entry Level (0 - 2 years)
  • Company Ref #
  • AJE Ref #

Job Description

br strong Description /strong br P Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science, and contribute to our unique culture. /P P This position focuses on the daily operations and activities within the Drug Product Development Process area, which includes operation of small scale screening, bench scale and pilot scale solid dose process equipment for conventional, enabled and nano-technology platforms. Candidate will work under the general supervision of the Formulation Lab Supervisor. /P P Responsibilities include weighing and dispensing of raw materials,  executing batch processes, setting, operating and cleaning of the process equipment and operations area / isolators according to established procedures. Scope will include operating in GMP and non-GMP settings. Lead Tech will serve as resource for training and guidance of junior staff members with set-up, operation, cleaning, compliance and documentation activities. /P P Responsibilities will include, but are not limited to, the following: /P P o Prepares equipment for manufacture. Operates process equipment per procedure and batch record instructions, and completes subsequent equipment and area cleaning activities per established procedures. /P P o Collaborates with Formulation Scientists in design of process and experiments. Effectively communicates results. /P P o Monitors and advances weekly process schedule assignments for DPD Facility in support of project and departmental objectives. /P P o Executes experiments / batch records and documents results using good Documentation Practices. /P P o Lead Technician mentors and oversees operations and activities of junior staff members for compliance, documentation and safety related activities /P P o Organizes and executes department specific tasks, e.g. Orders and maintains chemical and consumables inventories, leads equipment and facility cleanings / sanitizations.  /P P o Troubleshoot equipment and processes, provide feedback and initiate corrective actions. /P P o Supports departmental objectives Compliance, Environmental Health and Safety, budget, capital and equipment ordering, procedural directions. /P P o Works with potentially hazardous material in isolator / containment and / or gowning with personal protective equipment.  /P P o Assist with preparations for equipment installations into the facility. /P P o Assists with qualification activities (IQ/OQ/PQ) of new and relocated equipment. /P P o Assists with writing Standard Operating Procedures in support of department objectives. /P P o Collaborates and maintains strong working relationships with colleagues in Analytical R&D, Formulations R&D, Quality and other departments as applicable to conduct pre-formulation,  formulation and scaling activities as necessary. /P P o Partners with internal and external resources as necessary in support of department objectives. /P P o Provides samples to analytical testing labs ensuring proper handling and chain of custody. /P P o Assists with drug product process development / technology transfers to / from Contract Research / Manufacturing Organizations /P P o Supports safety, regulatory, compliance and departmental procedures in support of area operations.   /P