Principal Consultant, Sterility Assurance/Bioprocess (remote) at Pharmatech Associates

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Principal Consultant, Sterility Assurance/Bioprocess (remote)

Location: Boston, MA
Type: Full Remote

Posted: Oct 16, 2024

We are looking for a Principal Consultant, Sterility Assurance/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:

1. 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.
2. 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.
3. Serve as a QbD subject matter expert with respect to formulation development, process development, process transfer and scale up, tech transfer, and process validation.
4. 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.
5. Identify opportunities to reduce process variability which includes, but not limited to, conceptualizing and directing equipment solutions and refining/updating procedures and operational checklists and training guides.
6. This position will execute complex tasks and experiments independently, while mentoring and leading others during the course of a project.
7. Provide technical expertise and understanding on the qualification and requalification approach surrounding media fills, dose audits, EMPQ, and sterilization activities.
8. Develop Design of Experiments (DOEs), develop statistical sampling plans, assess and approve quality attribute requirements, as well as performing statistical analysis and evaluation of data to draw technical conclusions and make decisions.
9. Supporting as needed, our client’s sterility assurance programs and ensure compliance with all regulatory guidance, company procedures and good documentation practices.

Qualifications:

1. 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.
2. Travel without restrictions up to 20% for business development and to client project sites both domestically and internationally required.
3. Must have aseptic pharmaceutical experience with qualification for EMPQ, media fill, aseptic manipulations, clean room management, contamination control, and/or sterilization activities.
4. Demonstrated proficiency in Design of Experiments (DOE) and statistical analysis software (JMP, Minitab or equivalent) is required.
5. 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.
6. Excellent understanding of process design and optimization principles, CMC, root cause analysis methodologies is required.
7. Strong understanding of equipment qualification, validation, process scale up and tech transfer.
8. Strong knowledge of upstream and downstream bioprocessing and aseptic fill/finish.
9. Previous experience with the development and creation of Modules 2 and 3 of the eCTD.
10. Excellent writing 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.