Position/Title: Scientist II
- Function
Supports internal and externally-sourced pharmaceutical product development activities covering formulation development, process development, analytical development and validation, drug-device interface. CMC development, stability methods development and formulation development experience a must. Experience with nebulizer drug delivery, pulmonary drug delivery or sterile injectables strongly desired.
- Specific Responsibilities and Activities
- Evaluates formulations, drug product manufacturing processes, analytical methodologies for release and stability testing using internal and contract research organizations.
- Operates lab equipment to conduct experiments, interprets results to make recommendations and uses statistical mathematical techniques to analyze mathematical results.
- Executes GLP and GMP procedures in support of worldwide Regulatory submissions using bench methods in conjunction with human and animal clinical trials.
- Writes and reviews test methods, protocols and reports for accuracy.
- Writes documents pertaining to FDA submissions.
- Coordinate and monitor raw material, investigational drug, and comparator drug product release, labeling, shipping, evaluation, and stability studies.
- Requirements
- Education: - A minimum of a Master's degree in pertinent field of study and 3+ years of practical laboratory experience.
- Training and Experience:
- Must have some exposure to GLP/GMP training and analytical chemistry. Experience with developing inhalation products a plus.
- Computer literacy in WORD, EXCEL mandatory; POWERPOINT and Microsoft Project a plus.
- Physical Demands:
Normal office and lab activity, must possess the dexterity to use laboratory and computer equipment; may be required to stand for long periods of time performing experiments. May be exposed to hazardous materials. May be required to travel occasionally. Excellent written and oral communication skills and independent problem-solving strategies, together with the ability to contribute in a team environment are essential.
- Safety:
Must comply with MAP internal safety policies.
Send resume to:
Career OpportunitiesMAP Pharmaceuticals, Inc.
2400 Bayshore Parkway, Suite 200
Mountain View, CA 94043 Or e-mail resume to: hr@mappharma.com [ back to careers ]