Job Description
BryceTech is currently looking for a Principal Scientist I. This position will be supporting a high-visibility ASPR client managing over $21B in portfolio value with a variety of needs including support to the project team, acquisition program, and global health economic analysis efforts. This role will support the development and management of innovative government programs to expand the domestic industrial base for public health sector medical technology.
The person in this role will:
- Provide systems engineering and technical assistance to IBMSC in the establishment and implementation of a robust R&D program that incentivizes research and innovation in IBMSC product domain products, supplies, and manufacturing processes.
- Provide technical advice in the development of the environmental landscape Analysis of current industry capacities. Support to include defining product domain requirements based on existing government threat assessments and the commercial and government product delivery needs for each threat scenario.
- Serve as the technical lead (single point of contact) to the PMO / Tech Transfer portfolio.
- Develop technical transfer strategy for GMP activities at CMOs working across functional organizations including R&D, QC, QA, Regulatory, Supply Chain, etc.
- Ensure project plans adequately address technical Regulatory / GMP standards. Support risk assessments and troubleshooting activities to address out-of-specification (OOS) events.
- Lead communication and outreach to the research and development community.
- Communicate key data and conclusions to the Bryce tech team on the project as required to support key reports, studies, and decisions.
- Advise and assess testing and evaluation techniques.
- Lead cross-functional teams to perform process optimization, technology transfer, as well as investigations.
- Prepare, approve, and execute study and validation reports and protocols along with leading Quality by Design exercise and documents (process, IBMSC risk assessment).
- Contribute to Subject Matter Expert manufacturing investigations, monitoring of process performance (Lifestyle Process Validation Stage 3 Continuous Process Verification) to meet quality, yield, capacity, and timelines, give technical input for SOP's and production records, and troubleshooting equipment and processes.
- Support the review of business systems and tools designed to support ASPR.
- Travel on official business per the government’s request as required.
- Demonstrate proficiency with all MS Office products and Adobe Acrobat.
Qualifications:
- Bachelor's degree (BS) in scientific discipline (Chemistry, Biology, Microbiology, Pharmacy, or related field) with 10 years relevant experience, or graduate degree plus 5 years relevant experience.
- 16+ years of relevant experience in a scientific field including, but not limited to biology, chemistry, data science.
- Demonstrated experience developing technical transfer strategy for GMP activities at CMOs working across functional organizations including R&D, QC, QA, Regulatory, Supply Chain, and supporting risk assessments.
- Experience in a pharmaceutical or medical device manufacturing environment with technical skills in the manufacturing of solid oral dose, semi-solids, devices, and biologics.
- Knowledge of GMP regulations and guidelines.
- Manufacturing process validation experience required.
- Statistical analysis, JMP or Minitab knowledge a plus (QE tools).
- Experience in Data Analytics, Computer Modeling, and Digital Applications.
- Excellent verbal and written communications skills.
- Proficiency with all MS Office products and Adobe Acrobat.
Additional Information:
BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.
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