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Company

Pharmatech Associates, a USP company · 7 hours ago

Principal Engineer Consultant, Cell/Gene Therapy (remote)

San Francisco, CA

Full-time

Remote

Lead/Staff

10+ years exp

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ConsultingLife Science

Growth Opportunities

H1B Sponsor Likely

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Responsibilities

Support the Process Development and Production team. Focused on the support of clinical production in a cGMP facility, as well as, support of equipment design, scale-up, specifications, installations, commissioning, and qualification.

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 life science client; as well as execution of project deliverables.

Serve as a QbD subject matter expert with respect to formulation development, process development, process transfer and scale up, and process validation.

Design processes for validation, product/process transfers and continued process verification; including data analysis, gap analysis, identification of critical technical and compliance requirements, technical and compliance documentation review, and process metrics.

Evaluate incoming processes for operability and develop risk assessment plans

Qualification

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GMP manufacturingCell/Gene TherapyQuality by Design (QbD)Process design optimizationEquipment qualificationStatistical analysis softwareDesign of Experiments (DOE)SolidworksRegulatory complianceRoot cause analysisBioprocessingTechnical documentation

Required

Bachelor degree in a scientific or engineering related major plus 10 years’ experience within a GMP manufacturing environment in the biotech or pharmaceutical industry is required

Proven Autologous, Allogeneic Cell and/or Gene Therapy industry leader with a minimum of 5 years specific hands-on expertise in development and/or commercial operations.

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

Proficient with GDP, cGMPS, GLPs, ICH, CFR, and global regulations as appropriate.

Strong understanding of equipment qualification, validation, scale up and tech transfer

Knowledge of cGMPs and experience working in a GMP biotechnology or pharmaceutical manufacturing setting

Detailed knowledge of facilities, systems, and infrastructure within a regulated industry

Strong knowledge of upstream and downstream bioprocessing and fill/finish

Experience in Design of Experiments (DOE) and statistical analysis software (JMP)

Working knowledge of design (Solidworks) and fabrication of parts and assemblies

Company

Pharmatech Associates, a USP company

Pharmatech Associates is a global consultancy for the life science industry and advises U.S.

Founded in 1995

Hayward, California, USA

11-50 employees

https://pharmatechassociates.com/

H1B Sponsorship

Pharmatech Associates, a USP company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2020 (1)