Remote Consultant Jobs in Lynn ma

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Principal Consultant, Bioprocess (remote)

Location : Boston, MA

Full 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

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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