Reporting To: Director; AR&D
Location: Hauppauge, NY
The role of the Scientist II/Technical Writer, AR&D performs duties and responsibilities to ensure that technical documents in the R&D laboratory are compliant to company procedures and comply with regulatory requirements.
Responsibilities: Responsibilities include, but are not limited to:
- Write, revise and review documents including specifications, validation protocols and reports, SOPs and other technical documents.
- Assist in the gathering and summarizing of technical data and the preparation of technical presentations.
- Ensure that documents are reviewed and approved through the change control process, and follow up with reviewers and approvers, as necessary.
- Prepare and update specification for drug products and raw materials.
- Writes technical reports including compilation and analysis of data, justification of specifications, and technical memos.
- Provides editorial support, ensuring quality of all scientific content, with a focus on clarity, accuracy and consistency.
- Utilize scientific expertise to independently develop, validate and transfer analytical methods for drug substance, drug product and residuals (e.g. assay, related compounds, dissolution, residual solvents, elemental impurities, etc.).
- Perform routine analytical tests of in-process blend, blend challenge and stability samples to support the R&D formulation using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analysis, etc.
- Troubleshoot analytical methods for testing drug substances and drug products to support Quality Control Laboratories.
- Prepare result documentation for department and general review.
- Other responsibilities as assigned by Senior Management.
Education and Experience:
· Bachelor’s Degree in Chemistry with 4-5 years of pharmaceutical experience
· Master’s degree or Ph.D. in Chemistry with minimum of 3-4 years of pharmaceutical experience are
· Minimum 2 years of excellent technical writing experience.
Skills and Abilities:
· Thorough understanding of cGMP, FDA/ICH/EU regulations and guidelines
· Working knowledge of computer programs: Microsoft Word, Works, Excel, Publisher, Outlook, Empower 1-3, and EZChromeElite.
· Fast learner with ability to apply knowledge.
· Have the ability to work independently and manage multiple projects in a fast-paced environment.
CPC is offering a professional, stable work environment with excellent opportunity for career advancement in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, life insurance, paid time-off and 401(k) plan with matching contributions.