40 applicants

Company

Original Job Post

Avid Bioservices · 3 days ago

Associate Engineer, MSAT (Downstream)

Tustin, CA

Full-time

Onsite

Entry, Mid Level

$66K/yr - $88K/yr

1+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

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Responsibilities

Develop and cultivate positive client and internal partnerships.

Contribute to projects from start to finish with supervision.

Communicate with clients on process status and collaborate to resolve issues.

Provide technical expertise to support process tech transfers, troubleshoot process issues, and implement process improvements.

Author various technical documents including Manufacturing Batch Production Records, Technical Reports, and Standard Operating Procedures.

Contribute to scale-up assessments and equipment/facility fit assessments.

Assist in authoring technical risk assessments and provide technical training to Manufacturing Downstream Operators.

Research and identify new materials and equipment for continuous improvement.

Evaluate the impacts of process, material, and equipment changes on product quality attributes.

Perform statistical analysis of data and prepare analysis and reports of proposed changes.

Assist in CAPA investigations and recommend dispositions.

Perform other duties as assigned.

Qualification

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Downstream Biologic ManufacturingProcess DevelopmentQuality AssuranceDepth FiltrationAffinity PurificationIon ExchangeChromatographyViral InactivationTangential Flow FiltrationSterile FiltrationBulk Drug Substance FillsDownstream Process EquipmentAKTA Ready Column Chromatography SkidsLarge-Scale Filtration SkidsUnicorn SoftwareResolving IssuesScientific PrinciplesBatch Production RecordTechnical Risk AssessmentTechnical Protocol GenerationStudy ReviewTechnical transferScale-upMass transferJMP statistical software

Required

Bachelor’s degree in scientific or engineering (chemical or biomedical) discipline

Minimum of 1 year of downstream biologic manufacturing or process downstream development

Quality assurance knowledge

Hands-on experience with depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills

Hands-on experience with downstream process equipment including, but not limited to AKTA ready column chromatography skids, large-scale filtration skids, Unicorn software

Track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles

Batch production record, technical risk assessment, and/or technical protocol/study generation and review

Preferred

Master’s degree in scientific or engineering (chemical or biomedical) discipline

Technical transfer, scale-up, and mass transfer of downstream processes

JMP statistical software

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Matching

Paid Time Off

Company

Avid Bioservices

Avid Bioservices (NASDAQ:CDMO), is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biologics.

Founded in 1981

Tustin, California, USA

201-500 employees

https://avidbio.com

H1B Sponsorship

Avid Bioservices 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

Trends of Total Sponsorships

2023 (1)

2022 (5)

2020 (1)