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Principal Consultant, Bioprocess (remote)
Location: Boston, MAFull Remote
Posted: Oct 16, 2024
We are looking for a Principal Consultant, Bioprocess to join our consulting team and provide market leadership to the Life Science industry. This is a full-time salaried position with bonus and an excellent benefits package to attract top talent.
Job Functions
- Responsible for identifying opportunities to optimize client's process technologies and improve quality. This includes data collection and analysis to support new and ongoing process development and scale up activities.
- Provide broad-based consulting services to regulated life sciences clients; such services will include potential new client sales, develop proposals, project management as well as execution of project deliverables.
- Serve as a QbD subject matter expert with respect to process development, scale up and tech transfer, and process validation.
- Design processes for validation, product/process transfers and continued process verification; including data analysis, gap analysis, identification of critical technical, compliance and regulatory requirements, technical and compliance documentation review, and process metrics.
- Able to demonstrate knowledge of process comparability and product specification.
- Demonstrate understanding of control strategy and related methodology.
- Knowledge of equipment validation to meet specific equipment requirements related to process control.
- This position will execute complex tasks and experiments independently, while mentoring and leading others during the course of a project.
- Provide technical expertise and understanding on the qualification and requalification approach surrounding media fills, dose audits, EMPQ, and sterility assurance activities.
- Develop Design of Experiments (DOEs), knowledge of statistical sampling plans, assess and approve quality attribute requirements, as well as reviewing statistical analysis and evaluation of data to draw technical conclusions and make decisions.
- Supporting as needed, our client's quality activities to meet regulatory guidance, company procedures and good documentation practices.
Qualifications
- Bachelor's degree in a scientific or engineering related major plus 15 years' experience within a GMP manufacturing environment in the biotech and pharmaceutical (desirable) industry is required.
- Travel without restrictions up to 20% for business development and to client project sites both domestically and internationally required.
- Must have aseptic pharmaceutical experience with qualification for EMPQ, media fill, aseptic manipulations, clean room management, contamination control, and/or sterilization activities.
- Background in analytical development and Quality Control is a plus.
- Knowledge of Quality Target Product Profile, Critical Quality Attributes, and Critical Process Parameters as well as a working familiarity with Quality by Design (QbD) is essential.
- Excellent understanding of process design and optimization principles, CMC, root cause analysis methodologies is required.
- Strong understanding of equipment qualification, validation, process scale up and tech transfer.
- Strong knowledge of upstream and downstream bioprocessing.
- Previous experience with the development and creation of Modules 2 and 3 of the eCTD.
- Demonstrated proficiency in Design of Experiments (DOE) and statistical analysis software (JMP, Minitab or equivalent) is desired.
- Excellent writing skills and communication skills.
Pharmatech Associates, Inc. (a USP Company) provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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