Manufacturing Person In Plant (PIP) SME
- San Diego, CA
Sequoia Consulting Group provides world-class consulting services to the life sciences industry. Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulatory affairs and validation.
Sequoia's hands-on consultants provide technical knowledge and relevant life science experience to establish best practices in manufacturing, pharmaceutical and medical device companies. We are helping to produce better, faster and more economically priced medicines and medical devices around the world.
The Manufacturing Person In Plant (PIP) SME is responsible for the manufacturing oversight of our products at cGMP Clinical/ Commercial Drug Substance, Drug Product, Device Assembly, Process Characterization and Packaging CMO providers.
- Provide manufacturing oversight of our products at cGMP Clinical/ Commercial Drug Substance, Drug Product, Device Assembly, Process Characterization, and Packaging CMO providers.
- Manage the Technology Transfer (Tech Transfer) Process and/ or knowledge process, planning, and requirements from a transferring site to a receiving site. Specify in detail the information being transferred, scope and related activities - e.g. formulation, process and process parameters, package, testing methods, specifications, method validations, etc.
- Execute the CMO readiness mitigation plans to manufacture our products.
- Prepare a Tech Transfer protocol outlining the approach of transfer of process, methods and developed at company site to CMO site, following sequence of preparation of Technology Transfer Document Package, shakedown, engineering, and cGMP manufacturing runs.
- Generate protocols and reports governing applicable CMO product manufacturing stage gates supporting technology transfer.
- Coordinate the execution of Tech Transfer process utilizing specific protocols where appropriate, with each protocol clearly defining scope, activities, responsibilities and references appropriate to the stage of the product's lifecycle.
- Responsible for defining the list of documents required for Tech Transfer, review and revise the documents to ensure completeness.
- Lead in the coordination of CMO site meetings, updates, progress reports, adherence to the integrated project schedule, and Key Performance Indicators>
- Update the integrated project schedule allowing for adequate time needed to support the schedule.
- Ensure cross-functional participation on the Tech Transfer teams and coordinating team activities at the CMO Sites.
- Facilitate and schedule meeting with CMO and Company as required.
- Support the CMO audit prior to cGMP manufacturing/testing activities occur including addition of CSP to the Approved CSP list and implementing a quality agreement, as required.
- Support the regulatory and quality assessment of the CMO process development, manufacturing, and testing processes as applicable.
- Lead in the development of manufacturing change controls, back up, and documentation required to support the change.
- Support the demonstration that the product manufactured at the CMO is consistent with Process Development Consistency Runs.
- Lead in the execution of risk assessments that support the Tech Transfer process.
- Support scale-up activities from process development to CMO manufacturing.
- Ensure CMO’s equipment/ facility PM, Calibration, HEPA Certification and repair programs are aligned with industry standards/ cGMP’s in the production/support of pharmaceutical manufacturing.
- Ensure compliance with cGMP, regulatory, and industry standards.
- Support the identification and completion of change controls and Non-Conformance/CAPA.
- Communicate project status, schedule/budget/quality risks, mitigation recommendations with company stakeholders through regular written summaries, teleconferences and face-to-face visits.
- A Bachelor's degree in Engineering or Science preferred or specific biopharmaceutical experience required.
- 10+ years pharmaceutical CMC, process equipment, utility, validation, PM, calibration, capital project management, cGMP environments and regulations experience required.
- Possess pharmaceutical manufacturing and/ or engineering knowledge
- Must possess strong ability to negotiate and influence others internally and externally.
- Excellent computer, verbal, and written communication skills
- Innovative approach to problem-solving and integrated view of business/scientific issues
- Work independently in a matrix environment and manage multiple tasks simultaneously.
- Significant experience with MS Office Suite; Project, Visio, LIMS, and EDMS.
- Experience with cGMP Manufacturing and Quality Systems within a FDA regulated manufacturing environment.
- Experience in regulatory submissions, as it pertains to Validation, Manufacturing and Controls.
- Remains current on pharmaceutical regulations, industry standards, current practices, and new technology.
- Other skills and abilities as required.
Sequoia offers a comprehensive suite of benefits including, medical, dental, vision coverage, 401K, and company paid life-insurance.
Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.