12 days old

Project Manager Lead - Senior External Scientific Manager

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Project Manager Lead - Senior External Scientific Manager in Gaithersburg, MD to work a contract assignment of 11 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities of the** Project Manager Lead - Senior External Scientific Manager **includes:**


The Senior External Scientific Manager will manage the transfer, feasibility, and validation of virology (cells-based) assays [50%] and serology (immunology-based) assays [25%] and provide writing assistance for nonclinical and bioanalytical reports [25%]. The successful candidate will be part of a Translational Medicine team dedicated to developing novel biologics for the prevention of respiratory disease caused by respiratory syncytial virus (RSV).


The consultant will play a key role in laboratory assay remediation including:

(1) re-development and troubleshooting of existing assays with CROs

(2) oversight of assay tech transfer to CROs and the co-management of those relationships

(3) triaging of questions

(4) oversight of the standardization of assays

(5) development and review of validation plans

(6) review and composition of nonclinical and bioanalytical reports


Project Planning and Tracking

Co-manage project plans and change order management toward timely transfer and validation of virology (cell-based) susceptibility assays [50%] and serology (immunology-based) assays [25%] at CROs to support late-stage Phase 3 clinical and molecular surveillance studies

Responsible for creating and maintaining start to finish integrated deliverable timelines in coordination with Translational Medicine Lead and CROs

Track and update assay transfer, feasibility, validation progress

Scientific Support:

Responsible for providing scientific and technical oversight of CROs and diagnostic companies

Point of contact to triage questions related to sample specifications, SOWs, DTS, and sample collection, and analyses

Establishes standard requirements for outsourced biomarker assays (SOPs, QC/QA, CAPAs, and investigations)

Responsible for understanding and reviewing GLP/GCP documentation, method SOPs, qualification, validation, bioanalytical, and statistical reports

Develop validation plan and master schedule with CROs for all projects supported

Review, compose, and amend nonclinical and bioanalytical reports for regulatory submission


Communicates variances and CRO meeting minutes to Translational Medicine Lead

Makes detailed observations and demonstrates scientific rigor in the analysis of feasibility/validation data and fit for purpose assessment

Assist in the writing and review of analysis plans and regulatory nonclinical and bioanalytical reports


Essential Requirements

(1) PhD with 5 years of industry experience in development qualification/validation or cell-based and/or immunology-based assays

(2) Previous experience supporting regulatory documents needed for late-stage clinical bioanalytical/biomarker testing

Desirable Requirements:

Individual must have a strong background in clinical development of anti-virals and vaccines, therapeutic antibodies, clinical assay development and qualification/validation, and coordination of biomarker studies

Strong project management skills and regulatory experience with IND- or NDA/BLA-enabling studies

Excellent written, oral, and interpersonal skills

Strong organizational skills

Demonstrated ability to write technical reports, analysis plans, and perform quantitative analyses


Virology (Cell-Based) [50%]

Susceptibility of recombinant RSV variants to anti-RSV monoclonal antibodies by microneutralization phenotyping assay (multi-cycle and single-cycle)

Recombinant RSV engineering, rescue, and virus production

Serology (Immunology-Based) [25%]

Anti-RSV neutralizating antibody levels by serum microneutralization assay

Antibody levels to RSV antigens by RSV serology 5-plex MSD assay

**Education and Experience Requirement of the** Project Manager Lead - Senior External Scientific Manager **includes** :

+ PhD with 5 years of industry experience in development qualification/validation or cell-based and/or immunology-based assays

**Additional Information:**

+ Contract assignment, duration 11 months.

+ Work schedule: full-time, first shift.

**Kelly Temporary Employee Perks:**

+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts

**Apply Now!**

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:

Sandy at: (please reference BH Job #1656530)

Thank you for your interest in the assignment.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at


Posted: 2020-01-06 Expires: 2020-02-06

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Project Manager Lead - Senior External Scientific Manager

Kelly Services
Gaithersburg, MD 20898

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