Lead Technician, Drug Product Development
Other Locations:US- NJ- Summit West
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.
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.
Celgene Drug Product Development Operations seeks to hire a Lead Technician with oral solid dosage operations experience for (primary) GMP Manufacturing and (secondary) Development Manufacturing responsibilities. This position will report to the Manager of DPD Operations.
The Lead Technician position will focus on the daily operations and processing activities in support of Oral Solid Dose manufacturing; set up, controlled operation, troubleshooting and cleaning of process machinery and isolators. The position will support activities within the DPD GMP Manufacturing Area; but will also assist with operations in the Development (non-GMP) Process area as required.
The Lead Technician will also posess understanding of department and business processes in support of GMP And Development operations objectives, and is capable of performing the day to day operation under the general supervision of the Manager, DPD Operations.
The Lead Tecnician must be detail oriented, and have the ability to leverage prior relevant “hands-on” process knowledge, posess excellent technical and mechanical aptitude to set, operate and troubleshoot process equipment. They must also demonstrate strong communication skills and possess the ability to successfully interact with different groups across multiple levels withnin and external to the Drug Product Development Department.
Responsibilities will include, but are not limited to, the following:
- Coordinates and executes daily GMP (primary) / Development (secondary) operations of the Drug Product Development (DPD) Facility.
- Monitors and advances the weekly process schedule assignments in support of project and departmental objectives.
- Prepares and operates process equipment per procedure and batch record instructions, and completes subsequent equipment and area cleaning activities per established procedures.
- Oversee day to day GMP operations and activities of DPD staff members for compliance, docuemtnation and safety related activities.
- Executes experiments / batch record instructions and documents results using good Documentation Practices.
- Collaborates with Formulation Scientists/Engineers/ Area Management in design and exection of technical batches.
- Assists with the ordering and maintenance of chemical and consumables inventories.
- Able to work in and facilitate a 5S organized environment.
- Leads equipment and facility cleaning / sanitizations.
- Partners and mentors junior technicians, formulation scientists and engineers and serves as a Subject Matter Expert (SME) for multiple unit operations.
- Supports (scheduled and un-scheduled) activities related to equipment repair / preventative maintenance / calibration activities.
- Prepares and operates containment hoods and enclosures, monitoring performance and airflows.
- Posseses strong technical and mechanical skillset. Capability to troubleshoot process and equipment issues, provides feedback and initiate corrective actions.
- Supports departmental objectives - Compliance, Environmental Health and Safety, budget, capital and equipment purchase input, procedural directions and work practices.
- Capable of working with potentially hazardous material in isolator / containment and / or gowning with personal protective equipment / PPE / Respiratory protection.
- Understanding of Root Cause Analysis methods, CA/PA methods, implementation and tracking.
- Ability to lift up to 80 lbs when required in support of equipment set-up and cleaning operations.
- Assists with preparation and execution of equipment installations into the facility.
- Serves as department lead for commissioning / qualification activities and executions (IQ/OQ/PQ).
- Authors Standard Operating Procedures, work practices, checklists, development reports, etc. in support of department objectives.
- Develops and maintains effective working relationships with lab / area support staff, maintenance and calibration personnel in support of department operations.
- Partners effectively with internal and external resources as required in support of department objectives.
- Handles samples and materials ensuring proper handling and chain of custody.
- HS Diploma or Trade Certificate with 10 years relevant experience; Associates Degree with of 8 years relevant experience; or, Bachelor of Science Degree with 6 year relevant experience required in Pharmaceutical Science, Engineering or equivalent discipline preferred.
- Relevant experience in Oral Solid Dosage Development, GMP Process, Operations and Facilities.
- 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.
- Strong communication skills (oral, written, presentation).
- Ability to serve as training resource and partner with junior colleagues.
- Demonstrates strong equipment, process and problem solving capabilities.
- Hands-on experience, strong technical and mechanical aptitude skills required.
- Demonstrates strong proficiency with computer software programs / applications.
- Demonstrates initiative for advancement within department/organization.
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.