Celgene Senior Technician, Formulations Lab in Summit, New Jersey

Description

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.

Summary/Scope:

Celgene Corporation, a biopharmaceutical company, is seeking to hire a Senior Technician -Formulation Lab with oral solid dosage development and operations experience for GMP and non-GMP processes. This position will report to the Supervisor, Formulation Lab, Drug Product Development.

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. Candidate will work under the general supervision of the Formulation Lab Lead Technician or Supervisor. Responsiblities 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.

The Senior Technician will also accurately document all activities in batch records, notebook entries, equipment cleaning and use logs, or other worksheets. Senior Technician supports activities as directed by the weekly area schedule or supervisor’s directions. Senior Technician will stock and maintain inventory of materials, consumables, supplies, and Personal Protective Equipment. Technician will also support process activity work and equipment set-ups with formulation scientists, process engineers, lab support and maintenance / calibration personnel. Senior Technician develops understanding of department and business processes in support of operations objectives, and is capable of working independently. Senior Technician is capable of providing input on process activities and offering troubleshooting resolutions. Senior Technician serves to represent the area on specific operations / process / project related issues.

Senior Technician must be detail oriented, capable of working “hands-on”, and has strong mechanical aptitude. Senior Technician must also demonstrate very good communication skills and possess the ability to successfully interact with internal and external partners.

Responsibilities will include, but are not limited to, the following:

  • Participates in the daily operations of the Drug Product Development (DPD) Facility.

  • Prepares equipment for manufacture. Operates process equipment per procedure and batch record instructions, and completes subsequent equipment and area cleaning activities per established procedures.

  • Executes experiments / batch records and documents results using good Documentation Practices.

  • Collaborates with Formulation Scientists in design of process and experiments. Effectively communicates results.

  • Develops understanding and assembly of weekly process schedule assignments for DPD Facility.

  • Orders and maintains chemical and consumables inventories.

  • Responsible for equipment and facility cleaning / sanitizations.

  • Partners with junior technicians and serves as a training resource.

  • Develops and maintains effective relationships with lab support staff, maintenance and calibration personnel in support of department operations.

  • Under general guidance, coordinates equipment repair / preventative maintenance / calibration activities with process schedule.

  • Capability to troubleshoot and provide feedback for problem resolutions.

  • Capable of supporting departmental objectives – Compliance, Environmental Health and Safety, budget, capital and equipment ordering, procedural directions.

  • Capable of working with potentially hazardous material in isolator / containment and / or gowning with personal protective equipment.

  • General understanding of Root Cause Analysis and CA/PA methodologies.

  • Ability to lift up to 80 lbs when required in support of equipment set-up and cleaning.

  • Provides input for the planning and selection of Capital equipment purchases.

  • Assists with the planning and preparation of equipment installations into the facility. Assists with qualification activities (IQ/OQ/PQ).

  • Co-authors Standard Operating Procedures in support of department’s objectives.

  • 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.

  • Partners with internal and external resources as necessary in support of department objectives.

  • Provides samples to analytical testing labs ensuring proper handling and chain of custody.

  • Writes developmental reports as necessary.

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Qualifications

Skills/Knowledge Required:

  • HS Diploma or Trade Certificate with minimum 8 years relevant experience.

  • Associates Degree with minimum of 6 years relevant experience,

  • Bachelor of Science Degree with minimum of 4 year relevant experience required in Pharmaceutical Science, Engineering or equivalent discipline preferred.

  • Relevant experience in Oral Solid Dosage Development, GMP Process, Facilities and Operations.

  • Ability to work in isolator / containment apparatus, or while gowned with personal protective equipment.

  • Ability to lift up to 80 lbs. in support of equipment set-up and cleaning activities.

  • Ability to work in isolator / containment apparatus, or while gowned with personal protective equipment.

  • Very good communication skills (oral & written).

  • Ability to serve as training resource and partner with junior colleagues.

  • Demonstrate strong equipment, process and problem solving capabilities.

  • Hands-on experience and mechanical aptitude skills required.

  • Superior proficiency with computer software programs / applications.

  • Demonstrates initiative for advancement within department / organization

  • Superior proficiency with computer software programs / applications.

  • Demonstrates initiative for advancement within department / organization

Senior Technician, Formulations Lab

Location: Summit, NJ, US

Job ID: 17001582