Site Microbiologist - (Philadelphia, PA) - Philadelphia, PA | Biospace
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Site Microbiologist - (Philadelphia, PA)

MedImmune, LLC

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Location:
Philadelphia, PA
Posted Date:
9/24/2017
Position Type:
Full time
Job Code:
R-012738
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location:
Philadelphia, Pennsylvania, United States
Job reference: R-012738
Posted date: Aug. 17, 2017

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Site Microbiologist in Philadelphia, PA you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Main Duties and Responsibilities

Job Description

You will be responsible for the environmental monitoring program, utility monitoring, sterility assurance and aseptic operations at the Philadelphia, PA Manufacturing Center.  You will provide microbiology support to the QC laboratory.

Job Responsibilities

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

•             You will provide oversight of all aseptic operations

•             You will be required to work on plant floor side by side with production personnel and QAOTF to identify and correct microbial deficiencies

•             You will be responsible for aseptic training materials

•             You will review and approve technical documents e.g. aseptic practices, disinfectant efficacy, validation protocols, media fill protocols

•             You will review Environment and Utility alert and action excursion investigations

•             You will review trend reports, e.g. Environment and Utility

•             You will participate in the implementation of Corporate Strategies

•             You will oversee the environmental and utility monitoring program, including:

o     WFI, Clean Steam, Purified Water Testing

o     Compressed Air and Specialty Gases

o     HVAC System Testing (airborne viable/non-viable testing)

o     Surface Sampling (contact plate /swab)

•             You will conduct training for all microbiologically related training programs.

•             You will perform routine evaluation of aseptic practices within manufacturing.

•             You will direct the training and execution of the gowning program for qualification, disqualification and recertification of manufacturing operators.

•             You will work with lead investigator as SME for potential sterility failures.

•             You will be a member of the Site Operations Council, AZB Micro Forum, global Micro Forum and Aseptic Forum.

Typical Accountabilities

•             You will conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  You will complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   You will report potential issues of non-compliance.

In addition, for Managers and Project Team Leaders:

•             You will ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

•             Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness. 

•             Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

Requirements

Essential Requirements

  • Requires a Bachelor’s Degree in Microbiology, Biological Sciences or related discipline.
  • 8+ years of experience in biopharm, medical device, or pharmaceutical manufacturing
  • 6+ years of experience with Advanced Degree (MS or PhD)
  • Ability to work in a matrix environment.
  • Excellent communication skills (with staff, peers and upper management) and ability to develop rapport with other functional leaders to influence decision-making.
  • Ability to make effective decisions and do so in the absence of complete information and when under pressure.
  • Thinks more broadly than their role and uses this insight to challenge and adapt current approaches/ways of doing things.
  • Seeks to understand underlying issues/needs and proactively engages the customer in development of identification of solutions, products and services.
  • Ability to interpret and analyze statistical data and information and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing plant setting.

Desirable Requirements

  • Advanced Degree Desired.
  • Project Management experience.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

~bsp

*LI-MEDI