Process Advisor III

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 III shall be able to provide onsite presence at the manufacturing office/facility, which may involve extended travel, and shall monitor and report the contractor's progress, as well as any risks, issues, or problems identified.

Essential Job Functions:

• The contractor shall perform day-to-day oversight of activities at the manufacturing site as needed.
• The contractor shall ensure best practices and execution of current Good Manufacturing Practices (GMP) for development, manufacture, and release. The contractor shall identify upstream and downstream process changes to enhance compliance and improve the manufacturing process. In addition, the contractor shall develop process flow diagrams depicting the manufacturing process.
• The contractor shall work to maintain an IMS and ensure all tasks are completed within schedule expectations. The contractor shall assist the risk manager in risk identification, analysis, and mitigation.
• The contractor shall communicate technical and compliance risks and data.
• The contractor shall collaborate to develop resolutions to address risks or issues.
• The contractor shall assist with technology transfer efforts, to include working with the PM(s) and Manufacturing Lead(s) to develop a process for transfer of data, information, materials, and knowledge.
• The contractor shall review and provide comments to product transition plans, bridging studies, Technology Transition Agreements (TTAs) and Technical Data Packages (TDPs).
• The contractor shall assist with multiple complex technology transfer sub-projects related to manufacturing and testing to ensure that each sub-project meets cost and schedule expectations.
• The contractor shall verify that process parameters are still within the determined design space after technology transfer is complete. The contractor shall review and critique documentation and verification associated with the technology transfer processes.
• The contractor shall participate in routine and ad-hoc meetings and teleconferences to review and timely completion of action items and execution of technology transfers.
• The contractor shall collaborate on and review technical documents to advance development/acquisition. The contractor shall assist in writing and reviewing US CMC regulatory documents.
• The contractor shall review documentation and support resolution of deviations through corrective and preventive actions. The contractor shall review development and manufacturing data to ensure that processes are operating in a state of control. The contractor shall identify process changes to enhance compliance and improve manufacturing process, as needed.
• The contractor shall ensure appropriate subject matter experts are involved in the day-to-day management of manufacturing efforts. The contractor shall participate in various Government and non-Government IPTs.
• The contractor shall maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person. The contractor shall work independently and as part of a team.
• The contractor shall ensure that the CMO(s) meets best practices and execution of non-GMP manufacture of analytical reagents (e.g., recombinant Glycoproteins, monoclonal/polyclonal antibodies, etc.) used in testing of products during manufacture (i.e., in-process testing) and subsequent release. The contractor shall oversee process performance qualifications to ensure execution of current GMP during manufacturing, engineering, and production runs for both the drug substance and drug product (i.e. recombinant protein and viral vaccines).
• The contractor shall oversee the process to validate and complete all documentation required for introduction of new equipment.
• The contractor shall work in conjunction with the manufacturing team to review and identify errors in analytical assay reports, qualification/validation documents, and batch records (i.e., SOPs, manufacturing sections of SOWs, White Papers, RFIs, testing protocols, technical reports, batch files, and technical transfer documents).
• The contractor shall ensure the CMO identifies, in accordance with FDA/ICH guidance, the vendors, suppliers, and raw materials required. The contractor shall review training records of personnel at the CMO to ensure appropriate compliance and competencies.
• The contractor shall provide input to project schedule, cost estimation and budget management.
• The contractor shall provide input to autoinjector Integrated Product Team (IPT) meetings as follows:
  • Monitor and report on the standards employed by autoinjector manufacturers and how the standards are employed in the development or production of auto-injectors.
  • Prepare reports to evaluate the use and completion of risk assessment and problem-solving techniques by companies developing auto-injectors.
  • Provide input and assist in the development of regulatory strategies, target product profiles, and other regulatory documents related to the design, manufacture, and assembly of the device, obtaining input from subject matter experts as needed.
  • Review regulatory strategies related to technical manufacturing for accuracy and consistency.
  • Evaluate DoD acquisition documents that include FDA regulatory requirements or impact the drug development timeline.
  • Review and provide written feedback on technical records generated during the development process for accuracy and adequacy.
  • Evaluate change control documentation to determine product impact.

Necessary Skills and Knowledge:

• Shall possess technical knowledge of pharmaceutical manufacturing and an understanding of current GMP manufacturing. The contractor shall possess experience in biologics and the application of ICH Q8, Q9 QRM, and Q10.
• Possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work. The contractor shall possess strong interpersonal and communication skills, both oral and written.

Minimum Qualifications:

• PhD in Chemistry, Organic Chemistry, Biology, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience.
  • Tradeoff Requirement: Master's degree in Chemistry, Organic Chemistry, Biology, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
• Experience with the development, technology transfer, process definition, process qualification, and continued process verification of drug product manufacturing.
• Minimum five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
• Clearance: Secret

Pay and Benefits

The salary range for this position is $100,000 to $140,000 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.