GMP Manufacturing Technician III

General information

Organization

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Find out more about Orano Med  

Location

VA 24501

Job description (internal)

Orano Med Theranostics

Orano Med is seeking a detail-oriented GMP Manufacturing Technician III

We are seeking a highly motivated GMP Manufacturing Technician who will be responsible for non-clinical GMP manufacturing, maintaining the GMP suite and GMP equipment, as well as ensuring that all necessary documentation is maintained accurately in accordance with all applicable regulations. The GMP Manufacturing Technician assists with clinical material manufacturing as well as preparation for clinical product manufacturing. This position conducts routine maintenance of areas and equipment and maintains accurate records of operations within GMP suite.

Key Responsibilities

• Follow written procedures for non-clinical manufacturing
• Complete batch records, forms, equipment logs, and other production records as directed per company procedures and GMP guidelines
• Work concurrently with Quality Assurance (QA) and Quality Control (QC) personnel to deliver a high-quality product
• Follow and adhere to production schedules and timelines
• Execute room and equipment preparation for manufacturing operations
• Perform room sanitization activities as needed to maintain controlled environment conditions
• Participate in isolator and room monitoring
• Participate in room and isolator preparation for manufacturing
• Stocking materials in the GMP labs
• Identify and communicate process and equipment failures during manufacturing to supervisor and equipment team
• Identify process errors and report to supervisor
• Participate in deviation investigations and follow management guidance for corrective and preventive actions
• Clean, sanitize and sterilize equipment and components to support production operations
• Initiate cleaning procedures for the labs, perform routine maintenance on equipment, restock labs.
• Demonstrate ability to perform tasks with minimal guidance once trained
• Complete training on Master Batch Records, Formulation Records, and Protocols related to non-clinical manufacturing
• Complete on the job training for cleaning, gowning, GMP suite access, and equipment
• Primary operator for release testing of cold vials/syringes and solutions
• Monitoring of materials stock, requesting orders, obtaining relevant documents and submitting for release
• Assist in troubleshooting process errors
• Suggest corrective actions in support of deviation investigations
• Assist in editing non-clinical process & equipment documents

Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.

Skills and Qualifications (internal)

Education & Experience

Minimum Qualifications:

• Associate degree in a related field or comparable work experience
• 3+ years applicable work experience

Required Skills & Competencies:

• Chemistry or Microbiology lab experience, knowledge of chemical safety and lab hygiene
• Ability to work side by side with the quality assurance department.
• Excellent documentation skills and attention to detail
• Excellent communication, problem-solving and organizational skills
• Ability to follow written and verbal instruction and work under supervision
• Computer literacy and proficiency with Microsoft Office
• Ability to understand and exercise basic mathematical calculations and more complex calculations with various available tools and calculators
• Ability to work in a very fast-paced, high-growth team environment
• Ability to perform duties using proper aseptic technique

Preferred Skills & Competencies:

• Radiopharmaceutical manufacturing experience
• Communications Skills, Ability to Learn, Initiative, Dependability, Productivity, Quality of Work, Safety, Teamwork

Employment Classification

Regular/Permanent

Job

N - Laboratory

Customizable block no. 2
Overtime status

Non-exempt

Relocation

Not specified

Job location

America / Caribbean / Canada, USA, Texas

Geolocation by area (Always put 'Yes')

No

Adress

Plano

Additional information
Telework/Home-office

In Office

Applicant criteria
Travel

No

Handled by
Primary manager

LeKeta DAVIS

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