Product Compliance Scientist
Posted by PatricioEnterprisesLLC on March 14, 2019
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POSITION: Product Compliance Scientist
LOCATION: Fort Detrick, MD
STATUS: Full Time, Funded
TRAVEL: Minimal – up to 10% per year
CLEARANCE: Ability to obtain Secret Clearance/ NACI
BENEFITS: 401K, Life/Health/Dental/Disability Insurance, Paid Time Off, and Tuition Reimbursement.
DESCRIPTION: Patricio Enterprises is looking for a Product Compliance Scientist to provide regulatory, clinical, and technical (RCT) support services to support the U.S. Army Medical Materiel Development Activity’s (USAMMDA) mission to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. The primary objective is to provide RCT services as necessary to facilitate full program coordination, management, policy development, execution and oversight across all USAMMDA clinical, technical, and regulatory areas.
These support services cover the full range of clinical, manufacturing and regulatory professional disciplines necessary to perform the work efforts specified to perform regulatory, clinical and technical support services for USAMMDA. The Contractor will be required to provide support services to include but not limited to all personnel, equipment, supplies, facilities, transportation, tools, materials and supervision as necessary to perform to the standards in the solicitation
Primary duties will include (but not limited to):
- The Contractor shall provide support for a variety of investigational product development plans and efforts and provide knowledgeable regulatory compliance information relating to GMP, GLP, and GCP.
- Specifically, the Contractor shall provide commercial sector manufacturing perspective to Principal Investigators, advanced development Product Managers and others as they seek compliance with FDA rules and regulations.
- The Contractor shall consult on the developmental-appropriate scientific and documentation requirements for compliance of facilities/laboratories and associated assays and processes from the sponsor’s perspective.
- The Contractor shall interact frequently with Regulatory Affairs (RA) Scientists, Product Managers, Clinical Affairs, Branch Chiefs, Laboratory Directors, Laboratory Technicians, Quality Assurance representatives and the Director of Regulatory Affairs.
- The Contractor shall provide support by developing and assisting with laboratory and manufacturing compliance activities and related documentation to include those related to: product-related assays, product testing, accountability, manufacturing, laboratory, data systems and equipment.
- The Contractor shall facilitate efficient development of the product while ensuring compliance.
- The Contractor shall support product development strategy as it pertains to the extent of compliance needed as a function of the appropriate stage of product development.
- The Contractor shall provide manufacturing and testing related regulatory compliance information with appropriate individuals, teams and forums to reduce and/or prevent critical errors that may inhibit the development of products.
- The Contractor shall support (1) research protocol development and review, (2) assay development and validation, (3) regulatory compliance for clinical and non-clinical studies and (3) oversight of the performance of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), including site visits.
- The Contractor shall function as a representative on USAMRMC Product Teams and provide technical product manufacturing and testing, nonclinical testing and investigational product accountability support for efforts spanning the development life cycle, from early “tech base” to advanced development.
- The Contractor shall interpret FDA regulations and guidance and provide requirements and recommendations to USAMRMC Product Teams as related to product manufacturing, product release testing, nonclinical testing, analytical testing and validation efforts, in order to achieve FDA product approval.
- The Contractor shall conduct pre-qualification, for-cause, and person-in-plant manufacturing site visits; clinical site initiation visits, generate trip reports, document deficiencies and follow up with corrective actions.
- The Contractor shall communicate effectively and shall interface with RA Scientists, Quality Assurance representatives, Clinical Research Associates, and Product Managers as well as interface with other Government agencies and Contractors involved in medical product development efforts.
- The main focus areas for interaction and communication are in product compliance support, manufacturing, non-clinical study design, preparation of manufacturing and nonclinical sections of IND submissions and correspondence with FDA.
- The Contractor shall provide technical reviews and perform investigational product accountability with minimal supervision and shall demonstrate proficiency in FDA regulations and guidance. Technical documents include but are not limited to: product accountability records, batch production records, assay qualification/validation reports, SOPs, certificates of analysis, stability protocols and testing reports, analytical testing reports, animal study reports and packaging and labeling.
- The Contractor shall generate product accountability and product testing reports in accordance with USAMMDA SOPs.
- The Contractor shall develop SOPs, assist with document control, and perform administrative updates of regulatory documents as required.
- Personnel performing in this task area shall have the capability of applying experience in product manufacturing, testing and nonclinical studies in the application of US Code of Federal Regulations in relation to Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP).
- Personnel performing in this task area may require travel up to 10% of the year.
- Must have a BA degree (Master’s preferred) with a minimum of 5 years manufacturing experience.
- Equivalent education and/or experience in a related field will NOT be evaluated in lieu of above stated education.
- Must have experience specific to manufacturing drugs (not biologics or devices); topical cream/anti-infective preferred.
- Strong analytical experience in method development and validation.
- Experience in viscosity testing, HPLC, extractable /leachables, and diffusion testing.
- eCTD experience with NDA’s, knowledge of what is required and ability to thoroughly review for FDA submission.
- Experience with Pre-NDA CMC meetings as the representative who will be the FDA POC for CMC.
- Successful submission of NDA/product approval experience.
- Familiar with US Code of Federal Regulations in relation to Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP).
- Regulatory Affairs Certification (RAC) is preferred.
- Must be able to work independently following a brief period of specific technical training.
EOE. Protected Veterans/Individuals with Disabilities. Patricio Enterprises Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.
- Location: Fort Detrick, MD, Fort Detrick, MD ,
- Salary: Not provided
- Clearance Required: No
- Spouse Friendly: No