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Irfa******
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United States
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Last Update: 15.12.2018 at 12:00
Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Houston, US-TX
Country
United States
Category
General Administrative
Description
Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:
- As the technical product steward, act as a liaison between R&D Formulation, Technical Services and internal departments including Manufacturing and Quality to introduce new commercial products to the Site
- Work closely with quality and operations to evaluate deviations/complex investigations and out of specification results on commercial products. Provide technical support and expertise during investigations and problem resolutions. Perform investigatory activities including risk assessments as appropriate.
- Perform protocol activities for commercial products, developmental products, and for product transfers and launches. Record, evaluate, analyze and interpret experimental data.
- Observe and support the manufacturing of batches at the site, as requested, during process validation (PPQ). Provide input into critical operating parameters for manufacturing and packaging processes.
- Support developmental batches to enable post approval commercial batch improvements and issue resolution. Conduct procedures in compliance with established protocols, DEA, cGMP and regulatory guidelines. Provide risk assessments and technical justifications for change controls resulting from these process/product improvement activities.
- Present ideas for modifying existing procedures and recommend alternative methods to improve results. Maintain a level of scientific knowledge in assigned area; perform scientific literature searches and evaluations as required.
- Work closely with internal and external departments to ensure the efficient progress of projects. Interact with project management and key stake holders in a professional manner to ensure optimum manufacturing processes for commercial products, and products under development for transfer to the site.
- Assist manufacturing management on technical issues as needed whether directly or indirectly for all shifts.
- Support trouble shooting of pharmaceutical formulations and processes which may include analytical and technical review of data from all aspects.
Desired Skills and Experience
Make Our Values Your Values Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:- Minimum of a Bachelor's degree or equivalent in a science related field and 2-4 years of technical experience required. Minimum of 6-8 years of experience with liquids and semi-solid dosage forms preferred. However, a combination of experience and/or education will be taken into consideration. A Master’s degree in pharmaceutical sciences a plus.
- Must possess: extensive knowledge in liquid and semi-solid formulations and manufacturing methodologies, overall knowledge of pharmaceutical processes (development, manufacturing, packaging, regulatory), working knowledge of process improvement methods (Lean, Six Sigma), understanding of project and portfolio management techniques, and working knowledge of cGMP requirements. Must have a working knowledge of statistically based experimental design (DOE) and be able to interpret the results subjectively, objectively and practically.
- Must possess application of extensive technical expertise in liquids and semi-solids formulation and has working knowledge of other related disciplines. Develops technical solutions to complex problems which require the regular use of ingenuity and creativity. Excellent communication across a range of boundaries (functional, regional, level) and in a variety of settings (1 on 1, small groups). Deep analytical skill. Ability to work under moderate supervision for both work progress and results to meet department metrics.
- Proficiency in speaking, comprehending, reading and writing English is required.