Analytical R&D Manager
Location : Philadelphia PA US 19154
Job Type : Direct
Reference Code : 18676-AB-JC
Compensation : 100000.00 - 120000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 10
Required Education : BS Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for an Analytical R&D Manager to lead all analytical development for expanding Philadelphia area manufacturer of generic and branded pharmaceuticals. Specific responsibilities include:
- Oversee all method development, validation and documentation activities for ANDAs and product launches.
- Investigate and troubleshoot analytical issues.
- Manage equipment calibration and laboratory maintenance to comply with CGMPs, FDA and OSHA.
- Generate SOPs, technical documents, and new instrument Qualification program.
- Design of experiments including early stage product development Dissolution / Drug Release procedures.
- Complete US and EU regulatory documentation to ensure regulatory agency standards are met.
Required Qualifications :
- BS Chemistry (advance degree preferred).
- Minimum 10 years pharmaceutical laboratory experience including at least 3 years in a supervisory role.
- Proficient with validation of analytical. instrumentation such as GC, LC-MS, UPLC, HPLC, Titration, Dissolution, UV-VIS, and IR.
- Knowledge of Analytical Quality by Design and Design of Experiments.
- Able to lead root cause analysis and implement corrective actions in a timely manner.
- Experience implementing statistical techniques.
- Proficient in drug development and manufacturing regulatory requirements.
- Excellent project and time management skills, computer literacy, verbal and technical writing communication skills, presentation skills, interpersonal skills, leadership and teambuilding skills, and problem solving skills.
Contact: Jessalyn Cotter