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Formulation Development Cmc Jobs in Washington (NOW HIRING)

Fladger Associates

Senior Scientist

Gaithersburg, MD · On-site

$98.90K - $135.10K/yr

Experience with formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and/or CMC regulatory guidance and filings is preferred. * Skills leading ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site

$162.10K - $213.90K/yr

This includes developing the strategy, driving the formulation of the briefing document focused on ... development. * Understanding of non-clinical and CMC regulatory principles pertaining to CGT ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · Hybrid

$162.10K - $213.90K/yr

This includes developing the strategy, driving the formulation of the briefing document focused on ... development. Understanding of non-clinical and CMC regulatory principles pertaining to CGT ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site +1

$162.10K - $213.90K/yr

This includes developing the strategy, driving the formulation of the briefing document focused on ... development. * Understanding of non-clinical and CMC regulatory principles pertaining to CGT ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · Hybrid

$162.10K - $213.90K/yr

Regulatory Affairs Director Oncology R&D Gaithersburg, MD Hybrid Work- on average 3 days a week ... This includesdevelopingthe strategy, driving the formulation of the briefing document focused on ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site

$162.10K - $213.90K/yr

... to the development, commercialization and life cycle management of assigned oncology products ... Craft the health authority engagement strategy and interaction plan, drive the formulation of the ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD

$162.10K - $213.90K/yr

... to the development, commercialization and life cycle management of assigned oncology products ... Craft the health authority engagement strategy and interaction plan, drive the formulation of the ...

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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.

What are popular job titles related to Formulation Development Cmc jobs in Washington? For Formulation Development Cmc jobs in Washington, the most frequently searched job titles are:
What job categories do people searching Formulation Development Cmc jobs in Washington look for? The top searched job categories for Formulation Development Cmc jobs in Washington are:
Formulation Development Cmc jobs near you

Senior Scientist

Fladger Associates

Gaithersburg, MD • On-site

$98.90K - $135.10K/yr

Contractor

Posted 17 days ago

Job description

Gaithersburg, MD
Contract Duration: 12-36 months
Rate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Senior Scientist in the Gaithersburg, MD area.
  • The Late-Stage Formulation Sciences Group is responsible for development of intended commercial formulations to advance the late-stage biologics portfolio, and the life cycle management of commercialized products.
  • The group plays an integral part in the design and development of patient centric drug products.
  • This is a Scientific position, and the incumbent will be responsible for late-stage formulation development of biologic products.
  • Will be involved in the design and execution of formulation risk assessments and characterization studies, and development formulation control strategies for Drug Substance and Drug Product.
  • Ensure robustness of intended commercial formulations, suitability for intended use of container closure/packaging systems, and in-use compatibility with clinical administration components.
  • Expected to exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation.
  • Other responsibilities include authoring of marketing applications and provision of support to regulatory responses to approval.
  • Develop new strategies and approaches to advance late-stage formulation development and deliver scientific and operational objectives.

Experience:

  • BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, applied Sciences
  • Knowledge of protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or biophysical analytical methods is required.
  • Hands-on experience with high-performance size exclusion chromatography (HPSEC), particle characterization and sizing (e.g., light obscuration), and aggregate characterization methods are strongly preferred.
  • Experience with formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and/or CMC regulatory guidance and filings is preferred.
  • Skills leading, planning, and executing complex projects on tight timelines are important.