Job Description

Overview:
The Scientific Project Manager will be responsible for providing project management oversight to a biopharmaceutical client tasked with managing and executing analytical testing, method development and/or validation of such assays as immunoassays, bioassays, pharmacokinetic and/or flow cytometry assays under Good Laboratory Practices (GLP). He/she will provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis. The Sr. Project Manager must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports.
What will you do?

• Vendor Management:

• Lead the contracting with third-party lab service providers for assay development and validation.
• Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts.
• Study Coordination:

• Manage critical reagent supply and sample analysis.
• Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines.
• Support the development of novel Bioanalytical processes.
• Documentation and Data:

• Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs).
• Drive the delivery of data transfer specifications and ensure data accuracy.
• Sample Logistics:

• Track and reconcile sample testing, resolving any issues that arise.
• Contribute to cleaning and finalizing data.

What will you bring to the table?

• Bachelor's, or Master's level equivalent degree in Life Sciences or related field, required
• 2 - 3 years' experience in the drug development and/or clinical trial processes for Scientific Project Manager, required
• 5 - 6 years' experience in the drug development and/or clinical trial processes for Senior Scientific Project Manager, required
• Equivalent amount of experience managing projects, including timelines, budgeting and forecasting
• Extensive knowledge and experience in bioanalysis within regulatory environments (GLP/ GCP)
• PMP certified and formal change management training strongly preferred
• Highly proficient in MS Office Suite, including MS Project, Word, Excel and PowerPoint, Smartsheet and SharePoint
• Strong planning, attention to detail and organizational skills
• Excellent verbal and written communication skills

Working Hours, Location, Travel:

• Standard East Coast Business Hours
• Ability to be onsite in Gaithersburg, Maryland Monday - Friday for the first few weeks of orientation
• Upon completion of orientation, position will be remote with the ability to come into the office as needed for meetings
• Strong preference for candidates to be within a commutable proximity to Gaithersburg, Maryland. Will consider individuals on the East Coast as well
• Some travel required

Skills Required