Senior Scientist, Biologics
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POST DATE 9/9/2016
END DATE 10/20/2016
JOB DESCRIPTIONFOR US, ITS A MISSION
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the worlds 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing whats right, not whats easy. If you are a doer and have a passion for serving others, we want to talk to you.
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. Heres how this role will help:
* Provide technical expertise and experience and serve as a resource to the organization.
* Designing, planning and overseeing the conduction of pharmacology, safety pharmacology, toxicology and complicated mechanistic toxicology studies designed to address specific regulatory issues.
* Assisting in the selection, auditing and approval of contract testing facilities used for such studies, ensuring data quality and integrity from monitored preclinical sites.
* Comprehension of relevant Mylan Standard Operating Procedures (SOPs) and compliance with Laboratory SOPs and other relevant policies.
* Author and review research reports, protocols, guidelines and SOPs for the department.
* Provide support in the research and construction of regulatory study documents, technical scientific analyses and positional papers (i.e., IND/NDA documents, Applications for Marketing Authorizations, etc.).
* Represent the department and Mylan in meetings with global regulatory health authorities and attending internal meetings.
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:
* The preferred candidate will have a PhD with 2 years of experience in pharmaceutical laboratory or a minimum of 4 years with a Masters degree or 9 years with a Bachelor degree. However, combination of experience and/or education will be taken into consideration.
* Must possess knowledge of biologic and chemical analytical characterization including but not limited to HPLC, MS, LC-MS, MALDI-MS, AA sequencing, NMR, XRD, CD, FACS, immunogenicity, receptor binding and cell based assays.
* Must possess knowledge of the biological impact of drug materials in the human body and application of GLP and ISO regulations is required. Knowledge of applicable world health authorities regulations, standards and guidelines covering biological and biosimilar drug development is essential.
* Must possess effective organizational, oral and written communication and computer skills. Must be able to interact with a diverse workgroup in a team-oriented environment with the ability to communicate performance expectations in a clear and concise manner.
* Position functions semi-autonomously. Position directly supervises employees.Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.
* Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
* Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
* Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
* Proficiency in speaking, comprehending, reading and writing English is preferred.
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 30,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.
Job Posting: Sep 8, 2016, 7:29:38 AM
Unposting Date: Ongoing.