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Manager Environmental Monitoring/Microbiology, Lexington Site 9/8/2016

Shire Pharmaceutical Lexington, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
14521BR
AJE Ref #
576117294
Location
Lexington, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular

JOB DESCRIPTION

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Job Description
PRIMARY ROLE:
Job Summary/Operations Involvement:
Functions as an advisor to a unit regarding tasks, projects, and operations. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems.

Discretion/Latitude:
Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

Impact:
Ensures that projects are completed on schedule and within budget. Erroneous
decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds.

Specific QC Focus Areas:
Area focuses on microbiology laboratory techniques such as bioburden, endotoxin testing, microbial growth promotion, and basic benchtop chemistry, such as Total Organic Carbon (TOC), conductivity, and pH. Also included in the scope of the department is ownership of the site environmental monitoring program, that is inclusive of facilities, personnel, and qualified utilities.

RESPONSIBILITIES:
50%: Management of daily/weekly/monthly and longer term activities
of staff and operational oversight of group, data review,
scheduling, oversight of group training.
20-40%: GMP documentation related activities (ex. SOP revisions,
quality systems related events, method related project
documents as required), oversight of group metrics
10-30%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support

EDUCATION & EXPERIENCE REQUIREMENTS:
Typically requires a minimum of 10+ years of related experience.
(Science related degree is preferred)
Additional Specific Experience:
Relevant supervisory experience preferred.
Excellent communication, interpersonal and organizational skills.
Proactive at keeping current with literature and latest technologies.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements

OTHER JOB REQUIREMENTS:
Limited to no travel expected. Travel between sites is required.
The following physical abilities are required in order to fulfill the job duties:
-Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
-Ability to work around chemicals (if working around the laboratories)
-Ability to wear personal protective equipment such as gloves, gowning, and respiratory
protection in some cases
-Ability to walk and stand for periods of time
-Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

ABOUT SHIRE:
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.