Process Advisor V

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

Goldbelt Apex LLC is seeking a qualified Process Advisor V to support our Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance. You must be a U.S. citizen.

Responsibilities

Essential Job Functions:

• Assess results and progress relative to project objectives and communicate periodically/as needed to relevant leadership and stakeholders.

• Remain flexible to changing priorities and ideas while keeping project milestones on track.

• Propose and implement solutions to critical problems by creating actionable strategies and implementation plans to reallocate resources or efforts as required and oversight plans that use metrics for monitoring progress.

• Conduct required site visits of performers to assist in monitoring performance and quality standards, provide technical oversight, and assess capabilities and program progress.

• Lead focused working groups and provide detailed summaries (i.e., develop meeting minutes and track action items).

• Serve as the technical representative at conferences and stakeholder meetings.

• Draft reports, including executive summaries, manuscripts, and other technical documents.

• Participate in various Government and non-government IPTs.

• Ensure appropriate subject matter experts are involved in managing manufacturing efforts.

• Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person.

• Work independently and as part of a team.

• Serve as the technical point of contact for assay development, qualification, and validation efforts and provide technical and planning oversight and support for multiple priorities with aggressive timelines.

• Manage projects for multiple programs and projects across the portfolio

• Serve as the subject matter expert in CMC and non-clinical (pre-clinical)/clinical (humoral and cell-mediated) analytical methods, supporting stakeholder groups in resolution to investigations related to these methods.

• Provide detailed guidance on all aspects of manufacturing, preclinical/non-clinical, and clinical assay development, qualification, and validation, which may include assessments of various assay characteristics (e.g., accuracy, precision, dilutional linearity, range, LOD, LOQ, selectivity, specificity, robustness, and stability).

• Develop approaches to enhance CMC, preclinical, and clinical/non-clinical assay capabilities by providing detailed guidance on processes to eliminate failure modes and deficiencies.

• Serve as the technical interface between pre-clinical/nonclinical, clinical, and CMC stakeholders to establish, define, and validate CMC, preclinical/nonclinical, and clinical assays and to ensure compliance with regulatory and quality guidelines.

• Perform data-level technical and quality reviews of assay results and implications/interpretations to ensure technical and scientific data integrity and adherence to compliance with appropriate regulatory standards.

• Review all testing and data analysis aspects, detailing recommendations for paths forward for experimental design and execution, data evaluation, assay optimization, and validation, and documenting assay development progress.

• Develop and review qualification test plans for critical reagents, materials, and equipment used in analytical methods.

• Review and comment on technical protocols, validation plans, and regulatory submissions related to assay efforts to identify direct and indirect impacts on validation efforts and determine whether appropriate documentation is being generated, reviewed, and approved during design development.

• Provide subject matter expertise to other intergovernmental partners and liaise with the Technology Base (i.e., DTRA, USAMRIID, WRAIR, and HHS partners).

Qualifications

Necessary Skills and Knowledge:

• Capable of working independently and as part of a team.

• Possess strong analytical, critical thinking, and organizational skills to balance and prioritize work.

• Be initiative-taking, with great diligence and an ability to deliver results in a fast-paced environment.

• Possess strong interpersonal and communication skills, both oral and written.

• Possess familiarity and experience with ICH and regulatory guidelines applied to analytical aspects (i.e., FDA GLP and GMP).

• Possess an understanding of regulatory and quality compliance requirements.

• Possess state-of-the-art knowledge of all aspects of assay technology innovation, product development, and product enhancements.

• Possess a broad knowledge of the theory of operation and application of advanced bio-analytical assay methods and platforms (e.g., enzymatic, immunochemical, chromatographic, radiometric, mass spectrometric, ECL, PCR, SPR, etc.).

• Possess a familiarity with statistical methods and data analysis software

Minimum Qualifications:

• PhD in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.

• Tradeoff Requirement: Master's degree in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience.

• Possess experience in a regulated (i.e., GLP/GCP/GMP/CLIA) laboratory environment.

• Possess a minimum of seven (7) years of experience conducting and developing manufacturing, preclinical, or clinical assays to support vaccine licensure (with a preference for prior experience with all).

• Possess experience developing and validating (i.e., GLP/GMP) analytical and bio-analytical test methods.

• Possess experience independently designing studies and an ability to think critically and solve complex technical problems.

• Only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Preferred Qualifications:

• Active Secret clearance preferred.

The salary for this position is a minimum of $145,000 per year.

Pay and BenefitsAt Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.