Project Manager

Samyak Solutions Inc is recruiting for a Project Manager for Federal Laboratory Support Program- Eight FDA Field Laboratories.

FDA’s Office of Regulatory Testing and Surveillance operates eight high-throughput field laboratories whose analytical output supports regulatory action under the Federal Food, Drug, and Cosmetic Act. Those laboratories run on preparation. An analyst cannot plate a sample until media exists, cannot weigh a portion until glassware is clean, and cannot run chemistry when the deionized water system has drifted out of specification.

The Project Manager does not perform laboratory work. The Project Manager makes it possible for twenty-six people to perform it correctly, every working day, in eight buildings the manager is not standing in.

Position summary

The Project Manager is the single point of contact to the Government for technical direction and performance across the entire agreement. The role owns the deliverables required under the Statement of Work — a contract kickoff meeting conducted at FDA within ten working days of order award, a Management Plan delivered within thirty days and refreshed annually, and a Monthly Status Report submitted by the tenth business day of each month — and owns the mechanisms behind them: one intake channel for Government requests, one register of task status and coverage, one reporting rhythm at four tempos, and escalation thresholds agreed in advance.

Essential duties and responsibilities

Government interface and accountability

•    Serve as the sole point of contact to the Contracting Officer’s Representative for technical direction and performance across all eight laboratories.

•    Commit the company on coverage, schedule and corrective action within the awarded scope. Route anything affecting scope, price, period of performance or terms to the Contracting Officer through Samyak Contracts, never from a site.

•    Acknowledge every COR request within four working hours with either the answer or the date the answer will come.

Deliverables

•    Conduct the contract kickoff meeting at FDA within ten working days of order award.

Staffing, coverage and mobilization

•    Own the thirty-day mobilization: activate the warm bench, open badging at all eight laboratories in parallel, track every Government-dependent activity, and report progress by laboratory every week from day one.

•    Manage a Government-directed increase in level of effort from twenty-six to as many as thirty-eight technicians, submitting all surge badging packages within five business days of direction.

Quality, safety and risk

•    Ensure no technician performs any task independently before the site lead has documented competency on that specific task, following the FDA training the Statement of Work requires.

•    Ensure every technician holds OSHA 10-hour General Industry certification, which Samyak makes mandatory although the Statement of Work makes it optional.

Contract administration

•    Track hours worked and ensure all hours are reported and certified by the on-site laboratory supervisor or branch director before invoicing. Overtime, flexible schedules and telework are prohibited under this agreement.

•    Coordinate with corporate quality and contracts on FAR and HHSAR compliance, the PIV roster, and Invoice Processing Platform submission.

•    Support Service Contract Act compliance, including wage determination monitoring and price adjustment requests under FAR 52.222-43 at each option exercise or order anniversary.

 

Required qualifications

These are minimums. A candidate who does not meet all of them will not be advanced.

 | # | Requirement | 1 | Bachelor’s degree, or equivalent professional experience in place of the degree.
| 2 | Minimum five years managing multi-site federal service contracts, of which at least three involve direct supervisory responsibility for hourly personnel.
| 3 | Demonstrated experience managing a workforce covered by the Service Contract Act, including wage determination application and the practical effect of paid holidays, vacation and sick leave on billable hours.
| 4 | Demonstrated experience with HSPD-12 credentialing inside a federal facility: sponsorship, fingerprinting, adjudication and PIV issue, and the schedule consequences when any of those slips.
| 5 | Ability to obtain and maintain a favorable Tier 1 or higher background investigation and an FDA PIV credential. U.S. residency sufficient to satisfy HSPD-12 adjudication.
| 6 | Demonstrated ownership of recurring contractual deliverables to a federal customer, including monthly status reporting against a fixed submission date.
| 7 | Experience managing geographically dispersed personnel who are not co-located with the manager, in three or more locations simultaneously.
| 8 | Working knowledge of a quality control regime in which records support regulatory, audit or evidentiary use, and second-person verification is applied to recorded results.
| 9 | Ability to travel to eight laboratory locations across seven states as required, and to FDA for the contract kickoff.

 

Preferred qualifications

•    Direct experience supporting an FDA, CDC, NIH or other Department of Health and Human Services laboratory or field operation.

•    Experience in a regulated laboratory environment: media and reagent preparation, autoclave operation, deionized water systems, temperature mapping, chemical hygiene.

•    Experience mobilizing a multi-site services contract inside thirty to sixty days of award.

•    Experience managing a contract with a Government-directed surge in level of effort.

•    Project Management Professional certification, or an equivalent formal program management credential.

•    OSHA 10-hour or 30-hour General Industry certification.

•    Familiarity with GSA Multiple Award Schedule ordering, Blanket Purchase Agreements and labor-hour Call Orders.

•    Experience with a Laboratory Information Management System.