Job Location |
Geographic Location: Rockville, Maryland 20852
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| Reference Standards Manager-Lrg Complex Molecules |
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Function of the Position:
The Reference Standards Manager is a key supervisory position providing project management and technical leadership as well as staff development and mentoring. Reference Standards Managers are responsible for the training, development, and management of Reference Standards Evaluation (RSE) employees. The incumbent will utilize his or her technical expertise, knowledge of the pharmaceutical reference standard development process and current regulatory guidelines, and strong organizational and communication skills to ensure development of high quality reference standard materials. This is a critical role within the organization that oversees the operations of our organization's reference materials evaluation team.
Roles and responsibilities:
-Proactively involved in identifying solutions to the most critical technical problems related to the development of testing protocols and the analysis of data;
-Develops and mentors staff not only in company-related duties but also in scientific expertise, communication, and workplace relationships;
-Ensures consistency, timeliness, and the highest quality in all group outputs;
-Develops and integrates internal and external best practices to facilitate the delivery of superior results;
-Reviews and approves training documents, SOPs, and internal/external reports and communications;
-Sets group priorities and holds employees accountable for results;
-Leads, manages, and directs group activities (literature review, collaborative testing protocol development, troubleshooting of analysis methods, communication with internal and external customers);
-Leads the innovation and implementation of new processes that allow for continuous improvement;
-Ensures short/long term goals are set and met within timelines;
-Works with internal clients, manages projects appropriately, and ensures impeccable work-product delivery;
-Assists in the accomplishment of key departmental metrics; and
-Represents RSE products and scientific expertise at internal and external meetings, scientific symposia, industry forums, and Expert Committee meetings.
Frequent Contacts:
Reference Standard Evaluation personnel
RS Customers
Laboratory staff
Reference Standards Committee
External product suppliers and vendors
Minimum Requirements:
Ph.D. in Biology, Biochemistry, Microbiology, Chemistry or related field and 10 years of relevant experience. Minimum of seven years project lead and/or scientific reviewer experience required. Previous supervisory/mentoring experience with the ability to demonstrate superior leadership through interaction and communication, urgency, planning, and technical ability.
Knowledge, Skills, Abilities, Training and Experience:
Proven track record of consistently delivering projects on time and with high quality. Ability to rapidly assess technical complications to identify, define, and solve technical issues. Skill to increase the knowledge, abilities, and contributions of staff and promote staff development. Broad knowledge of projects and technologies within and outside the laboratory. Proficient with testing involving analytical methods for raw materials. Proficient in related analytical analysis and instrumentation (HPLC, CE, NMR, ICP, AA, KF, UV, LC/MS, GC/MS). Ability to review, analyze, interpret and report on data from various analytical tests. Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal. Strong presentation skills. Prior experience in biological reference standard development, testing, or production is a plus. Experience with the development of biological pharmaceuticals and refining specifications during the development cycle. Knowledge of and experience with stability programs.
Supervisory Responsibilities:
Supervises a team of Reference Standards Scientists
ideal candidate will have strong experience in Biology, Biochemistry, Microbiology and/or Biotechnology...some sort of Bioscience background.
Candidates must meet the Minimum Requirements stated on the position description
SCREENING Q:
Do you have experience with pharmaceutical reference standards development, particularly in the area of biologics?
Salary to ~$135k DOE
Relocation assistance
Interview travel reimbursed |
Job Details |
Date Posted: 05/18/2012
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Position Type: Professional
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Job Status: Full Time
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Specialty Type: Administrative Medicine |
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Employment Setting: Not Specified
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