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Assistant Manager, Operations

Pharmaceutical Product Development (PPD)

Germantown, Maryland, United States of America

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Summary

Responsible for the overall management of the laboratory within DMID-CMS. Coordinates the daily activities of the laboratory and assists the Operations Manager with the oversight of the activities of bio-specimen technicians. Ensures bio-specimens are securely and properly maintained and documented through receipt, storage, handling, and shipment processing. Monitors quality of work and performs audits. Acts as the primary contact for DMID-CMS bio-sample projects. Responsible for growing and developing new laboratory services and developing new client services for DMID-CMS. Develops and critiques contract standard operating procedures, manuals, reports and improves processes using the PPI Business System. Assists the Project Director in planning, coordinating, and conducting contract administrative and repository technical operations. Assists with the design and implementation of special projects as specified by customer.

Key Responsibilities:

  • Coordinates daily operations of the DMID-CMS bio-specimen repository
  • Works with clients, vendors, project officer, and clinical sites to coordinate operations, provide services, and meet contract objectives
  • Ensures bio-specimens are properly maintained and documented through receipt, storage, handling and shipment processing
  • Coordinates laboratory technicians providing training and feedback
  • Coordinates the preparation of contract reports, SOPs, and manuals
  • Implements policies and procedures, monitors safety, security, and quality
  • Assists in planning, coordinating, and conducting contract administrative and repository technical operations, including special projects
  • Ensures repository operations and procedures align with all applicable local, state, federal and international laws, standards, and regulations
  • Coordinates with other contractors to ensure specimen data is maintained

Qualifications:

  • 3+ years experience in project management and proven leadership skills.
  • Experience handling bio-specimens and biohazardous materials.

Education/ Training:

Bachelor’s degree in science or equivalent education and experience.

Specialized Knowledge /Skills:

  • IATA (International Air Transport Association) and DOT (US Department of Transportation) certified training on the handling and shipping of Dangerous Goods
  • Experience in working within the current Good Manufacturing Practices (cGMPs) environment.
  • Knowledge of Import/Export Regulations and Controls
  • Hazardous Material Disposal training
  • Biological and Chemical Safety procedures

Supervisory Responsibility:

Supervise contract personnel in DMID-CMS daily operations.

Ability and/or Skills:

  • Knowledge of storage and handling procedures for biological materials
  • Safe handling of infectious materials
  • Biological laboratory procedures and aliquoting techniques
  • Safe handling and disposal of bio-hazardous materials
  • Collaborative attitude, customer-focused
  • Quality driven focus
  • Strong understanding of quality assurance/quality control procedures
  • Excellent computer skills and inventory database management
  • Excellent oral and written communication skills

Physical Demands:

Must be able to lift up to 50 lbs, 1 hour per day

Must be able to use a computer up to 8 hours per day

Must be able to handle materials frozen on dry ice (-79C) or liquid nitrogen (-195C) for up to 4 hours per day

Participation in blood draw program is recommended

Participation in Hepatitis B vaccination program is recommended

Working Conditions:

Warehouse, Office, some work in refrigerators and freezers

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Job posted: 2024-03-20

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