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All Analytical Development Cmc Jobs in Virginia (NOW HIRING)

Granules

Scientist III, Analytical R&D

Chantilly, VA · On-site

$85K - $95K/yr

Plan and design of experiments toward answering CMC deficiencies responses. * Perform ... Conforms to all training requirements, including company required and regulatory requirements

Granules

Manager, Analytical R&D

Chantilly, VA · On-site

$100K - $130K/yr

Conforms to all training requirements, including company required and regulatory requirements ... In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance.

CMC

Shop Superintendent

King George, VA · On-site

$107K - $130K/yr

... development opportunities * Set production requirements based on customer needs and ensures the ... CMC is committed to providing equal employment opportunities (EEO) to all employees and applicants ...

New

Moderna

Intern, CMC Development (Summer 2027)

Norfolk, VA · On-site +1

$20 - $60/hr

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... all employees and qualified applicants without regard to a person's race, color, sex, gender ...

Moderna

Intern, CMC Development (Summer 2027)

Hampton, VA · On-site +1

$20 - $60/hr

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... all employees and qualified applicants without regard to a person's race, color, sex, gender ...

Moderna

$20 - $60/hr

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... all employees and qualified applicants without regard to a person's race, color, sex, gender ...

Moderna

Intern, CMC Development (Summer 2027)

Norfolk, VA · On-site +1

$20 - $60/hr

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... all employees and qualified applicants without regard to a person's race, color, sex, gender ...

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All JobsAll Analytical Development Cmc JobsAll Analytical Development Cmc Jobs in Virginia

All Analytical Development Cmc information

What is the difference between All Analytical Development Cmc vs Analytical Scientist?

AspectAll Analytical Development CmcAnalytical Scientist
CredentialsBachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related fields; relevant certificationsBachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related fields; relevant certifications
Work EnvironmentPharmaceutical or biotech R&D labs, manufacturing supportResearch labs, quality control, or manufacturing settings
Industry UsageUsed in CMC (Chemistry, Manufacturing, and Controls) documentation and developmentCommonly used in analytical testing, method development, and validation

All Analytical Development Cmc professionals focus on developing and validating analytical methods specifically for CMC documentation and regulatory submissions. Analytical Scientists often work on analytical testing and method development across various stages of product development. While both roles require similar educational backgrounds and work environments, All Analytical Development Cmc roles are more specialized in CMC processes, whereas Analytical Scientists may have broader analytical responsibilities.

What is the job description of analytical development?

Analytical development involves designing, validating, and implementing analytical methods to characterize and ensure the quality of pharmaceutical products. Professionals in this field use techniques such as chromatography, spectroscopy, and other laboratory tools, often working in regulated environments that require compliance with Good Manufacturing Practices (GMP). The role typically requires strong laboratory skills, attention to detail, and knowledge of regulatory standards.

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All Analytical Development Cmc jobs near you

Scientist III, Analytical R&D

Chantilly, VA • On-site

Granules Pharmaceuticals
See more jobs at Granules Pharmaceuticalsexternal

$85K - $95K/yr

Full-time

Re-posted 10 days ago

Job description

Job Type
Full-time
Description
Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!
With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.
We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.
Job Duties & Responsibilities
Plan and execute method development, method validation and tech transfer activity for API, excipient, package components and Finish Product.
  • Oversees analytical techniques, interpretations of analytical data, problem solving and troubleshooting as required for Analytical R&D activities.
  • Prepare and review SOPs, protocols, reports, to support laboratory GMP function in compliance with FDA, ICH and other regulatory guidance.
  • Plan, review and implement additional studies (e.g., cleaning validation, Photostability, any in-use studies, Multimedia dissolution, shipping study, etc.)
  • Plan and design of experiments toward answering CMC deficiencies responses.
  • Perform Investigations (Out of trend, out of specification and laboratory deviations) as per SOP.
  • Conforms to all training requirements, including company required and regulatory requirements
  • Manages the AR&D function in the laboratory to ensure cGMP compliance.
  • Other duties related to departmental activities may be assigned by the management based on the requirement.
  • Provide regular timely reports, interpret analytical data and present results to the manager AR&D and Head as needed.

Management Responsibility
  • Reviews staff's performance regularly and develop team members to continually enhance both individual and overall work team performance.
  • Take an active role in identifying training needs, challenge and develop both direct and indirect reports in their positions for future opportunities.

Reports to
Manager to Analytical R&D.
Knowledge & Skills
  • Knowledge of API, excipient and finish product in generic pharmaceuticals.
  • Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size.
  • Functional understanding of small molecule analytical development and associated regulatory and quality requirements.
  • In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance.
  • Excellent verbal and written communication skills.
  • Excellent problem solving and interpersonal skills.

Requirements
Experience & Education
  • Master's degree in Analytical Chemistry or Chemistry or related field with 5+ years OR PhD with 3+ years of experience
  • Experience small molecule solid oral dosage analytical development is required

Physical Requirements/Working Environment
  • Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE.
  • Vision - ability to see details at close range (within a few feet of the observer).

Disclaimer
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.
Salary Description
$85,000 - $95,000/ Yearly

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