Extrusion Operations Manager Jobs in New York (NOW HIRING)

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.

Ardena is hiring a Pharmaceutical Technician I to join the Operations team at our Somerset site. This role supports pharmaceutical development and manufacturing activities within a GMP-regulated environment.

As a Pharmaceutical Technician at Ardena, you will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within the [Department]. You will work in a regulated pharmaceutical environment, ensuring that all work meets GMP, GxP, and applicable ISO standards.

You will collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, Project Management, Production, and other departments across Ardena’s European and US sites.

This is a cross-functional position encompassing, but not limited to the Dispensing, Milling, Blending, Granulation, Fluid Bed Coating, Compression, Encapsulation, Tablet Coating manufacturing processes. Specifically, optimal skills would be - Hot Melt Extrusion, Wet and dry granulation, Glatt Fluid Beds, (Top spray, bottom spray and drying), Roller Compaction. Must be able to keep accurate and detailed records, understand batch records and maintain cleanliness of work area. Must follow standard operating procedures.

• Utilizing the current dispensing systems of scales and balances, accurately weigh/dispense and label raw materials for manufacturing.
• Accurately prepares for return to the warehouse all partial raw material containers, defaces and disposes of all empty raw material drums as per current SOP’s.
• Checks for accuracy all materials delivered from the dispensing area as well as all in-process materials from the prior unit operation as per current SOP.
• Performs all the duties necessary to mill, blend and granulate drug products which includes the disassembly, cleaning, set-up and operation of milling, blending and granulation manufacturing equipment.
• Performs all the duties necessary to compress and encapsulate drug products, which includes the disassembly, cleaning, set-up and operation of manufacturing equipment such as but not limited to Tablet Presses, Capsule Fillers, Dedusters, Metal Detectors, Disintegration Testers, Friabilators, Tablet and Capsule In Process Weight Check Systems, Hardness Testers and Micrometers.
• Performs all the duties necessary to film coat drug products, which includes the disassembly, cleaning, set-up and operation of manufacturing equipment such as but not limited to various size Fluid Beds, Coating Pans, Solution Tanks, Spray Guns and Mixers.
• Will maintain the immediate work area in a clean and safe manner and perform room and equipment cleanings as needed.
• Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
• Comprehends and adheres to all cGMP’s and other Regulatory requirements.
• Comprehends and adheres to all related SOP’s as well as Batch Records and Protocols.
• Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure.
• Completes all required training activities.
• Clearly and accurately completes all required GMP documentation.
• Perform room and equipment inspections and completes all pertinent documentation.
• Other duties as assigned.

• High School Diploma or equivalent is required.
• 2+ years of prior experience in a pharmaceutical, biotech or food manufacturing environment (regulated by GMP standards and requirements for 2+ years) is preferred; with specific experience in oral solid dosage manufacturing (milling, blending, granulation, fluid bed, Hot Melt Extrusion, compression, capsule filling or pan coating manufacturing processes).
• Expert in at least one manufacturing discipline.
  • Optimal skills would be - Hot Melt Extrusion, Wet and dry granulation, Glatt Fluid Beds, (Top spray, bottom spray and drying), Roller Compaction.

• Ability to utilize hand tools to assemble and disassemble various types of machinery.
• Ability to follow instructions and procedures (SOPs, cGMPs).
• Work in a safe manner.
• Legible handwriting skills.
• Proficient reading and comprehension skills.
• Strong leadership skills.
• Strong decision-making skills.
• Technical skills/trouble shooting skills. Demonstrate a high level of technical expertise and problem-solving skills.
• Exemplary leadership skills, demonstrate the ability to lead project team (coach, train, mentor team members). Mathematical and reasoning ability.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work effectively under pressure to meet deadlines.

• Individual may be required to sit, stand, walk regularly.
• Individual may be required to bend, kneel, crouch, and stoop.
• Occasionally lift 0-50 pounds.
• Individual may be required to wear a respirator for several hours at a time due to work associated with potent compounds.
• Be accessible to manufacturing floor and office staff and to use required office equipment.
• Specific vision requirements include reading of written documents and frequent use of computer monitor.

• Must wear safety glasses, in addition to other specified PPE, in all designated areas.
• Must follow any applicable plant safety requirements.
• Must be fit-tested as per OSHA regulations, trained and capable of wearing air purifying respirator.
• Must be trained in plant hazardous material procedures.
• Must use approved fall prevention devices when performing elevated tasks.
• Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift.
• Working conditions will be Temperature and Humidity controlled as needed for product.
• Individual’s primary work-area is located in the operations area, where the noise level can be moderate to high. Certain operations may require hearing protection.

Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.

Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations.

• Competitive salary and tailored benefits package (adjusted per role and location)
• Flexible working arrangements and paid annual leave (where applicable, depending on role and site)
• International and collaborative work environment across European and US sites
• Access to professional development and training programs
• Meaningful work on pharmaceutical development projects that advance patient health
• A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent
• Salary Range: $60,000 - $72,000 DOE