Responsibilities:

1. Works in active principle (API) and finished product.
2. Develop analytical methods (mixing uniformity (BU), content uniformity (CU), testing, immediate and prolonged release solution, degradants, organic impurities, others).
3. Develop protocols to validate analytical methods and their reports.
4. Write reports of analytical methods; Test/BU/Solutions/degradants/enantiomers, etc.
5. Write reports of generation and justifications of specifications according to ICH/FDA guidances.
6. Write deviations found in protocols and solve it.
7. Develop of methodology for degradation studies.
8. Develop of methodology for the determination of residual solvents by GC technique, asset residues (cleaning methods), water determination (Karl Fischer), particle size, and others.
9. Maintain excellent communications with upper management and colleagues of other functional areas to assure consistency with customer policies, procedures, and processes.
10. Participate in staff meetings, as requested, and provide periodical project
11. status reports.

Job Requirements:
1. Education:

• Bachelor’s or Master´s Degree in Science

2. Experience:

• Three (3) to Five (5) years of related experience in Pharmaceutical, Consumer Products Manufacturing, and/or Medical Devices environment.

Required.

• Familiar with standard concepts, practices, and procedures within a particular field.
• Knowledge in HPLC and GC, particle size meter.
• Knowledge in formulation and handling of excipients.
• Experience in binary studies, studies, and interaction of excipients.
• Experience in the development of dissolution studies in different biological pH media.

3. Skills:

• Initiative, organized.
• Committed to meet with delivery dates of results, protocols, and projects.
• Availability to work overtime and weekends, first or second shift (1:00pm-9:30pm).
• Strong leadership, communication, and interpersonal skills.
• Team oriented, dependable, self-starter.
• Ability to work independently and as part of a team, self-motivated,adaptable, dependable, and with a positive attitude.
• Ability to learn new techniques, perform multiple tasks simultaneously, attention to detail, keep accurate records, follow instructions, and comply with company policies.
• Strong computer, scientific, and organizational skills.
• Work with limited direction and may provide guidance and coordinate work activities of other personnel.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.