Analytical Scientist Iv

Analytical Scientist IV

Location: Rockville, MD [100% on-site]

Type: Full-Time

On Demand Pharmaceuticals (ODP) is changing the way we make and distribute medicinesby providing them to everyone, everywhere, anytime. ODP is creating innovative manufacturing platforms to enable our vision to produce critical medicines at the point of care and to secure the pharmaceuticals supply chain. As a young organization, ODP offers an exciting opportunity for passionate scientists and engineers to make a difference in the world while developing career paths for advancement. ODP is seeking a Scientist to support the development of our next generation medicine manufacturing platforms.

Summary of Job Position:

Participates in analytical development and/or routine testing activities. Utilizes established scientific techniques to compile and analyze data to evaluate the quality of products. Writes technical reports detailing procedures, outcomes, and observations.

Responsibilities:

• Analytical method development, validation and transfer

• Drug Product, Drug Substance and Excipient characterization

• Lead Troubleshooting of analytical methods including chromatography and mass spectrometry

• Analytical physiochemical methods subject matter expert

• Assign and oversee routine analysis of raw materials, intermediates, and final products independently

• Review and approve analytical data and results

• Train team members on analytical methods and techniques, including USP

• Assign priorities to team members

• Ensure compliance with Quality Systems

• Provides technical support to team members (method development, validation, routine analysis)

• Assist in supporting day-to-day laboratory operations

• Independently generate sound analytical data and produce the associated technical reports

• Conduct verification and/or validation of methods execution

• Writing and/or approval of technical documents (e.g; qualification, validation, stability protocols, etc)

• Maintain Quality Control related documentation (QC SOPs and methods, test methods, analytical validation and/or qualification, reference standard qualification, and stability studies, specifications)

• Maintain data within company data integrity standards

• Assist with other analytical services as needed

Physical Demands/Work Environment:

• Ability to safely handle hazardous materials

• Ability to move 50 pounds

• Ability to bend to reach floor level

• Ability to wear respirator

Minimum Hiring Standards:

• Minimum of a bachelor's degree in chemistry, pharmaceutical sciences or related field; or training and equivalent work experience at a level that equates to B.S. degree

• Minimum 6-8 years of experience of analytical testing in a pharmaceutical Quality Control or Analytical Development Laboratory environment

• cGMP training including FDA and ICH guidelines

• Ability to write/type/review large volumes of information with excellent attention to detail

• Ability to operate, troubleshoot, and maintain analytical instrumentation

• Ability to write instrumental protocols and instructions

• Ability to develop and troubleshoot analytical methods

• Experience in modern analytical techniques including HPLC, GC, Mass Spectrometry etc.

• Demonstrate excellent attention to detail, ability to learn instrumental techniques, and maintain good record keeping

• Ability to work collaboratively with multi-disciplinary cross-functional research teams

• Energy and passion to thrive in a start-up environment and to deliver on the mission of On Demand Pharmaceuticals

On Demand Pharmaceuticals is an equal opportunity employer.On Demand Pharmaceuticals does not discriminate in employmentwith regard torace, color, religion, national origin, citizenship status, ancestry, age, sex(including pregnancy, gender identity, or related medical conditions), sexual orientation, marital status, physical or mental disability, past or presentmilitary serviceor any other charac