Process Advisor V (Auto-injector/ Combination Products Process Advisor)

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

Summary:

The Process Advisor V (Auto-injector/ Combination Products Process Advisor) with the CTO Program Office shall have demonstrated experience providing advice, developing documents and reviewing deliverables to integrated product teams and/or working groups for development of auto-injector products.

Essential Job Functions:

• The contractor shall participate in product development teams, review regulatory strategies with special emphasis on technical manufacturing issues, evaluate contract proposals specific to the manufacturing development plan, ensure all areas specific to device manufacture are in the right development order and appropriate for the development effort.
• The contractor shall be able to review the technical records generated during the development process for accuracy and adequacy, evaluate change control documentation to determine product impact and assure the Design History File(s) are current, robust and meet all FDA, ATSM, ANSI, and ISO requirements. The contractor will monitor and report on the standards employed by auto-injector manufacturers and how the standards are employed in the development or production of auto-injectors.
• The contractor shall be able to articulate plans, proposals, concerns etc. verbally in meetings, as well as write reviews/white papers or other documentation succinctly and clearly for all products in development by the US Government.
• The contractor shall have the necessary skills to be effective in a team environment (active listening skills, persuasive abilities and collaborative skills).
• The contractor shall evaluate DoD acquisition documents that have FDA regulatory requirements or impact the drug development timeline. Technical/Regulatory Tasks:
• The contractor shall have familiarity and experience evaluating manufacturing processes using all ISO and ASTM standards related to combination products, including but not limited to ISO standards 7886-1, 10993-1, 11608 (all parts), 10993-1, 13485, and 14971, as well as ASTM D4169. The contractor also needs to have familiarity with FDA guidance for industry including, but not limited to, "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products" and related class II devices under 21 Code of Federal Regulations (CFR) 880.5860 and 21 CFR 880.6920.
• The contractor shall be able to review on-going technical efforts to assess appropriateness and identify gaps in the current device design, manufacturing development pathway. The contractor will provide a report on appropriateness and gaps in device design and manufacturing.
• The contractor shall be able to assess the adequacy of human factors and functional testing to determine the appropriateness of the methods, conduct of the studies, and study reports in order to ensure that the studies will meet FDA requirements. The contractors will evaluate and report on human factors and functional testing supporting autoinjectors to support FDA submissions.
• The contractor shall be able to provide input and assist in the development of regulatory strategies/target product profiles and other regulatory documents as related to the design, manufacture and assembly of the device.
• The contractor shall have experience evaluating feedback and preparing submissions for the FDA review centers involved in the approval of combination products, particularly the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH).
• The contractor shall be able to review regulatory submission documents as related to manufacturing for accuracy, and consistency; as well as assist with the development of regulatory documents with input from appropriate SMEs.
• The contractor shall have experience with relevant risk assessment and problem solving techniques which could include failure mode effects analysis (FMEA), fault trees, and root cause analyses. Contractor will prepare reports evaluating the use and completion of these by companies developing auto-injectors.
• The contractor will be able to review a technical document and provide comments in writing to ensure accuracy.
• The contractor shall be able to review and report on Design History Files supporting combination products, including auto-injectors.
• The Contractor will be able to ensure that protocols, data collection forms and subsequent study reports are consistent, accurate and the data supports the stated results.
• The contractor will be able to conduct on-site visits to ensure the data collected is supported by the raw data. The Contractor will prepare reports of their visits that will be shared with the entire development team.
• The contractor will be able to evaluate the testing facility, its personnel and equipment meet minimum requirements required of FDA combination product regulations and guidance documents.
• The contractor will be able to convey observations made at on-site visits against standards or regulations. Communication:
• The contractor shall be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures; and self-starting.

Necessary Skills and Knowledge:

• Shall have an in-depth knowledge of combination products, specifically auto-injector development, including knowledge of device development; engineering design, including engineering drawings; component development molding processes; cartridge fill/finish and primary container closure systems; automation of auto-injector manufacturing; have detailed working knowledge of Design History Files, inclusive of legacy products being updated to current cGMP standards as demonstrated in both previous experience and training courses.

Minimum Qualifications:

• PhD in Molecular Biology, Biochemistry, Microbiology, or Biochemical Engineering with extensive knowledge of Virology or Vaccinology (preferably both), as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: Master's degree in Engineering, Biomedical Science, Device Manufacturing, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience.
• The contractor shall possess an advanced degree and relevant experience (>10 years preferred, >5 year minimum) in the medical device and combination product industry.
• Clearance: Secret

Pay and Benefits

The salary range for this position is $150,000 to $175,000 annually.

At 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.