Requirements
- Bachelor’s degree in chemistry/Engineering/any scientific discipline
- 12 years of relevant experience in a GMP environment that constitutes Drug Substance, Drug Product, and Packaging and Labeling
- Prior experience with Electronic QMS systems (Veeva preferred)
- Demonstrated knowledge of FDA/EMA/ICH standards and regulations
- Demonstrated knowledge of Risk Assessment and Root Cause Analysis (5 WHYs, FMEA)
- Demonstrated ability to effectively organize, and work in a fast-paced environment
- Demonstrated ability to function individually and in a team environment
- Working knowledge of relevant manufacturing equipment and operations and analytical testing and quality control oversight.
- PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
- Windows, MS Office (Outlook, Word, Excel, PowerPoint).
- Knowledge of other software required: e-QMS (e. g. Veeva), ERP systems, Interactive Response Technology (IRT) for Clinical Supplies, and Serialization.
Nice to Have
- Solid dosage experience
Benefits
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
- top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- a winter company shutdown
Additional Information
- Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
- Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
- You may be required to travel for up to 10% of your time.
