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Stability Project Coordinator

Your Role:

 

The Project Specialist/Stability Coordinator is responsible for administration of Product Characterization Stability projects in a capacity which includes the collection, management and distribution of project control information.  For Stability projects, oversight of the project scope and deliverables as outlined in the custom proposals is essential.   

 

The Stability Coordinator will be responsible for effective communication with cross-functional teams, such as Project Management, Development Services, Sales and other Operations Laboratory teams which will be essential to maintaining accurate, up-to-date schedules.  The successful candidate must possess strong communication skills, both formal and informal. 

 

Finally, the Project Coordinator will assist with study management responsibilities including scientist review data, investigation of deviations, updating SOPs, managing CAPAs and GCCs and signing reports.

 

  • Liaise with project management, account managers, development services as well as operations scientific staff on the progress and deliverables for each stability project
  • Liaise with continuous improvement and digitization project leads on process improvement efforts.  Coordinate with lab management on resources needed for such projects
  • Manage stability project timelines and communicate any timeline risk or misses to appropriate parties
  • Manage deliverables for each proposal milestone and ensure that any project scope creep is documented and actioned appropriately
  • Assist in the creation and management of Product Characterization stability project scheduling
  • Work with lab supervisor(s) and/or lab management to ensure that routine testing is scheduled appropriately to meet on time delivery expectations
  • Review / Edit Stability proposals
  • Author Stability protocols and work with client on project requirements/timelines
  • Attend all team meetings
  • Study management duties which include the scientist review of data, investigation of deviations, updating SOPs, managing CAPAs and GCCs, and signing reports

 

Who you are:

Minimum Requirements:

  • Ph.Din scientific discipline (Biology, Biochemistry, etc.) with 1+ years’ experience in laboratory setting – OR –
  • Master’s degree in scientific discipline (Biology, Biochemistry, etc.) with 2+ years’ experience in laboratory setting – OR –
  • Bachelor’s degree in scientific discipline (Biology, Biochemistry, etc.) with 3+ years’ experience in laboratory setting – OR –
  • Associate degree in scientific discipline (Biology, Biochemistry, etc.) with 6+ years’ experience in laboratory setting – OR –
  • High School Diploma or Equivalent (i.e. GED, etc.) with 9+ years’ experience in laboratory setting

 

Preferred Qualifications:

  • Experience with relevant laboratory practices, techniques, equipment, materials and mathematical calculations
  • Strong organization skills and professional conduct
  • Working knowledge of the ICH guidelines regarding stability
  • Intermediate skills in applicable  computer programs including proficiency with Microsoft Office Suite
  • Excellent oral and written communication skills, both formal and informal that have been demonstrated through presentations/seminars, oversight of projects, etc.
  • Ability to work in cross functional teams as well as independently 
  • Demonstrates  a high level of initiative and leadership capabilities
  • Highly technically competent

 

RSRMS

Job Requisition ID:  207014
Location:  Rockville
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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