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Minaris Advanced Therapies · 3 days ago

Laboratory Technician III - Validation on Demand

Philadelphia, PA

Full-time

Onsite

Mid, Senior Level

3+ years exp

Minaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing. The Laboratory Technician III will support the Viral Clearance Validation on Demand Team by performing assays and laboratory maintenance in compliance with regulatory guidelines.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Conducts viral clearance assays and lab procedures as outlined in testing record and regulatory guidelines

Performs basic maintenance and inter-study changeover of AKTA FPLC systems

Operates in a team-based environment on the execution of nanofiltration and column chromatography steps in the performance of viral clearance studies

Accurately completes testing records and other required documentation according to Good Documentation Practices

Reports observations of ongoing tests to Study Director or Laboratory Supervisor/Manager

Communicates with Supervisor and other colleagues re: daily lab activities

Performs lab upkeep per GLP, cGMP, CFR and/or PTC guidelines and SOPs

Prepares reagents and restock labs with supplies

Maintains equipment, equipment logs, cleaning logs and initiate change controls

Aids in the training of new employees

Performs self and peer review of testing records to ensure documents are accurate and complete

Authors non-conforming events and laboratory investigations

Evaluates SOPs for accuracy and efficient operations and makes amendments as necessary

Understands the importance of the regulatory compliance and comprehension of the laboratory assays

Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required

Normally receives minimal instruction on routine work and detailed instructions on new assignments

Contributes to the overall operations and to the achievement of departmental goals

Performs job specific tasks in compliance with applicable regulations, international standards, Minaris Advanced Therapies’ Policies and SOPs

Regular and reliable attendance on a full-time basis

Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture

Qualification

Downstream purificationChromatographyNanofiltrationAseptic techniqueCell biologyVirologyAKTA FPLCUnicorn SoftwareMicrosoft ExcelMicrosoft WordMicrosoft OutlookDocumentation PracticesEffective communicationTime managementTeamwork

Required

Laboratory experience with emphasis on aseptic technique, cell biology and/or virology

Possesses a foundational knowledge of functional equipment used in down-stream purification operations

Effective multi-tasking skill and time management required

Ability to evaluate technical data and record data accurately and legibly

Ability to understand and follow verbal and demonstrated instructions

Ability to clearly express and exchange ideas by means of verbal and written communication

Ability to work effectively as part of a team and exhibit effective interpersonal skills

Ability to work under limited supervision and to handle problems of a difficult nature

Proficient in oral and written communication skills

Proficient in Microsoft (Excel, Word and Outlook)

High school diploma and over 6 years of relevant experience or Associates/Bachelor (science preferred) degree with over 3 years of relevant or equivalent experience

At least 2 years of relevant experience in downstream purification, chromatography, nanofiltration or a combination thereof

Preferred

Knowledge of GDP, GLP and cGMP preferred

AKTA FPLC and Unicorn Software experience is a plus

Benefits

Medical insurance

Vision insurance

Dental insurance

401(k)

Paid time off

Tuition assistance

And more

Company

Minaris Advanced Therapies

Minaris Advanced Therapies is a global cell and gene therapy (CGT) CDMO and a multimodality biosafety testing provider.

Founded in 1999

Allendale, New Jersey, USA

1001-5000 employees

https://www.rm.minaris.com

H1B Sponsorship

Minaris Advanced Therapies 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

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Trends of Total Sponsorships

2024 (1)

2022 (1)

2021 (1)