GMP Production Associate

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 Production Associate

This position is primarily responsible for manufacturing GMP clinical materials and products. This position is also responsible for maintaining the GMP production suite and GMP equipment, as well as ensuring that all necessary documentation is maintained accurately in accordance with all applicable regulations. The GMP Production Associate performs clinical product manufacturing as well as preparation for clinical product manufacturing. This position conducts cleaning and routine maintenance of areas and equipment, edits documents, and maintains accurate records of operations within GMP suite.

Key Responsibilities

All Production Associate levels:

• Follow written procedures for clinical and non-clinical manufacturing as primary operator or verifier
• Participate in release testing of cold vials and solutions
• Complete batch records, forms, equipment logs, and other production records as directed per company procedures and GMP guidelines
• Work concurrently with Quality Assurance (QA),Quality Control (QC), and Logistics personnel to deliver a high-quality product
• Adhere to production schedules and timelines
• Execute room and equipment preparation for manufacturing operations
• Perform room sanitization activities to maintain controlled environment conditions
• Participate in isolator and room monitoring
• Maintain stock of manufacturing raw materials and obtain necessary documentation to submit for release
• Identify and communicate common equipment/process failures and report to supervisor
• Participate in deviation investigations
• Clean, sanitize and sterilize equipment and components to support production operations
• Initiate cleaning procedures for the labs, perform daily checks and routine maintenance on equipment, restock labs.
• Maintain up-to-date training on all manufacturing records
• Assist in review of manufacturing documents
• Maintain gowning and production qualifications

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

All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.

Minimum Qualifications:

• Bachelors degree in a related field or comparable work experience
• 1+ year's experience

Required Skills & Competencies:

• Demonstrated skills in GMP manufacturing and documentation requirements.
• Proficient in aseptic technique.
  Ability to work side by side with the quality assurance department.
• Ability to maintain inventory of raw materials.
• Ability to troubleshoot equipment and process failures
• 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 or independently
• 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 stand, crouch, sit, bend, or stretch for extended periods of time
• Demonstrate ability to perform duties using proper aseptic technique and following ALARA principles for working with radioactive materials

Preferred Skills & Competencies:

• Demonstrate ability to perform tasks with minimal guidance once trained
• 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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