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Formulation Development Cmc Jobs in Texas (NOW HIRING)

Orano

Process Development Scientist

Plano, TX · On-site

The successful candidate will design, execute, and analyze studies and create reports for R&D CMC ... Collaborate with cross-functional teams to review protocols, batch records, formulation records ...

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Formulation Development Cmc information

What are the key skills and qualifications needed to thrive as a Formulation Development CMC specialist, and why are they important?

To thrive as a Formulation Development CMC specialist, you need expertise in pharmaceutical sciences, chemistry, and regulatory guidelines, often supported by an advanced degree in a relevant field. Familiarity with analytical techniques, formulation equipment, and regulatory submission systems like eCTD is crucial. Strong problem-solving skills, attention to detail, and effective collaboration are essential soft skills in this role. These competencies ensure the successful development, optimization, and regulatory approval of safe and effective pharmaceutical products.

What are some typical challenges faced by professionals in Formulation Development CMC, and how are they addressed?

Professionals in Formulation Development CMC often encounter challenges such as ensuring formulation stability, meeting regulatory requirements, and scaling up from laboratory to manufacturing. Addressing these challenges requires close collaboration with analytical, regulatory, and manufacturing teams, as well as staying current with evolving guidelines. Effective project management, rigorous experimental design, and proactive risk assessment are key strategies to successfully navigate these complexities and ensure timely progress of drug development projects.

What is Formulation Development CMC?

Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition of a drug product, ensuring it is safe, effective, and stable for patient use. This role involves selecting appropriate excipients, developing the manufacturing process, and generating the data required to support regulatory submissions. CMC professionals collaborate with research, quality, and regulatory teams to ensure that the drug product meets all necessary standards throughout its lifecycle.

What is the difference between Formulation Development Cmc vs Formulation Scientist?

AspectFormulation Development CmcFormulation Scientist
CredentialsBachelor's or Master's in Pharmacy, Chemistry, or related fields; industry certificationsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields
Work EnvironmentPharmaceutical or biotech R&D labs, manufacturing settingsResearch labs, development facilities, pharmaceutical companies
Industry UsageRegulatory submissions, product development, manufacturing supportFormulation research, experimental design, product optimization

Formulation Development Cmc focuses on developing formulations suitable for regulatory approval and manufacturing, often involving documentation and compliance. Formulation Scientists primarily conduct research and experiments to create and optimize formulations. While both roles require similar educational backgrounds and work in related environments, Cmc roles emphasize regulatory and manufacturing aspects, whereas Scientists focus on experimental research and innovation.

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Formulation Development Cmc jobs near you

Process Development Scientist

Orano

Plano, TX • On-site

Full-time

Posted 24 days ago

Job description

Description
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
We are seeking a highly motivated Process Development Scientist with expertise in radiopharmaceutical development to join our CMC team. The successful candidate will design, execute, and analyze studies and create reports for R&D CMC to support the development of novel radiopharmaceutical compounds. This role offers an opportunity to contribute to groundbreaking therapies and collaborate with cross-functional teams to advance our pipeline toward clinical trials.
Key Responsibilities:
  • Design, conduct and optimize R&D studies to characterize radiopharmaceutical compounds.
  • Analyze, interpret, and troubleshoot complex datasets.
  • Scale up, write reports and transfer processes from R&D to GMP manufacturing teams.
  • Review and further develop & refine existing processes.
  • Collaborate with cross-functional teams to review protocols, batch records, formulation records, deviations and other related documents.
  • Maintain accurate records of experiments and ensure data integrity in accordance with company policies.
  • Stay current with advancements in radiopharmaceutical science and contribute to the development of innovative research strategies.
  • Other duties, as needed.

Requirements
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 :
  • Ph.D. in biological sciences, or related field
  • 3+ years of demonstrated research experience in a pharmaceutical/biotech setting

Required Skills and Competencies:
  • Excellent analytical and problem solving/problem resolution skills
  • Experience working with radioisotopes
  • Experience working in a pharmaceutical/biotech setting
  • Excellent written and verbal communication skills
  • Ability to manage multiple projects and prioritize workload efficiently
  • Ability to work independently
  • Strong interpersonal skills and ability to work collaboratively in a team-oriented environment

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