Contract Method Validation Jobs in Maryland (NOW HIRING)

Position Summary:

The Senior Scientific Director, Flow Cytometry will use their scientific expertise to lead development and validation efforts for Flow Cytometry assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research.  As a team leader with direct reports, the person will train and mentor staff to ensure scientific rigor and use their expertise to guide assay development and troubleshooting.  The position requires direct experience in all aspects of regulated and non-regulated cellular assays and must have working knowledge of all current regulatory guidance and industry best practices. The person will also engage with QA to maintain regulatory compliance and work with project managers ensure timely and efficient client communication. Lastly, ideal candidate will have had experience with hosting and/ or participated in regulatory audits.

Essential functions of the job include but are not limited to:

• As Head of laboratory this position is fully responsible for all scientific activities, regulatory compliance, staff, and metrics associated with clients and product delivery.
• Mentor and lead all scientific staff assigned to Flow Cytometry assays (including receptor occupancy, as well as internal and external cellular markers).  Ensure proper method development and validation of projects so they are quality driven and executed against communicated timelines and milestones.
• Direct scientific staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects and client studies.
• Participate actively in the Flow Cytometry community to ensure Precision is fully aware of any all-relevant guidance for regulations pertaining to Flow Cytometry.
• Serve as Technical Lead (Subject Matter Expert) for all Flow Cytometry Assay Projects.
• Serves as Project Director or Principal Investigator as required.
• Lead the scientific team in the design and execution of all experiments, ensure all data is accurately analyzed, quality driven and delivered to clients on time.
• Communicate clearly (written and verbal) and often with clients and ensure product delivery is within client expectations for all projects associated to Flow Cytometry assays.
• Lead the team in establishing, writing, reviewing and/or improving all procedures (SOPs POPs), study Protocol/plans, assay validation/verification and associated reports.
• Identify, update and implement emerging laboratory techniques and/ or instrumentation.
• Work collaboratively with other technical teams in resource sharing and providing technical expertise.
• Write and prepare abstracts, techniques/or draft scientific papers to maintain the scientific standard and image of the company.
• May present completed work at appropriate scientific meetings and in publications.
• Responsible for trouble shooting and correcting routine scientific issues/problems in a timely manner.
• Act as a scientific resource externally to clients and internally on Product and Services/ R&D related projects
• Assist with writing, reviewing and editing contract and grant applications/proposals as appropriate
• Maintain and support safe lab practices and environment
• Carry out other duties/projects as assigned

Qualifications:

Minimum Required:

• PhD in life sciences or relevant field in life sciences and at least 18 years of full-time relevant laboratory experience or equivalent combination of education and experience.
• 10 years of management experience.
• A solid understanding of current GxP or CAP/CLIA/ISO standards.
• Previous work experience in GLP or GCLP or CLIA regulatory compliance.

Other Required:

• Expert level human Flow Cytometry assay experience.
• Experience in handling various sample types such as plasma, serum, and PBMCs.
• Experience developing flow cytometry panels on fresh and fixed cells.
• A solid understanding of current method validation standards.
• Excellent communication, interpersonal, and organizational skills required.
• Must have the ability to organize and analyze data, as well as prepare reports
• Must possess strong computational skills, preferably experienced with Word, Excel, Power Point, Gen5 and GraphPad Prism
• Excellent use of judgment and discretion required.
• Extended work hours may be occasionally necessary in order to meet business demands.
• Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20C -196C)
• Must be able to read, write, speak fluently and comprehend the English language.