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Thermo Fisher Scientific · 3 weeks ago

Sci III - Process Development

Plainville, MA

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $125K/yr

5+ years exp

Thermo Fisher Scientific Inc. is the world leader in serving science, and they are seeking a Scientist III for their Downstream Process Development team. The role involves planning, designing, and implementing laboratory activities while serving as a subject matter expert in downstream processing for viral vectors.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Lead planning, tech transfer, process development and scale up activities (both bench and pilot scale) and preparing summary reports/presentations

Review and author documents (development plans, batch records, SOPs, protocols, summary reports), including deviation and/or investigational reports

Lead multiple projects; handle project tasks and timelines

Independently design experimental plans, perform studies, and analyze and report study results and recommendations both verbally and in written formats

Lead all aspects of downstream execution with members of the larger team while acting as a SME for downstream viral vector processing. Train junior team members

Collaborqate with clients, ensures accurate data and presentations to presented to clients. Assist in preparing detailed process development reports for products at different phase

Support sourcing, purchase, installation, startup and calibration and maintenance of Process Development equipment

Collaborate with global BPS team, Quality, and Project Management teams to facilitate technology transfer and project success

Lead Practical Process Improvement (PPI) initiatives

Qualification

Downstream processingChromatographyViral vector purificationCGMP knowledgeStatistical analysisCommunicationLeadership skillsInterpersonal skillsFlexibility

Required

B.S. in (bio)Chemical Engineering, Biochemistry, or related field with 5 yrs., Masters with 2 yrs. of industrial experience, or Ph.D

Design and execution of chromatography, tangential flow filtration, depth filtration, viral clearance, and ultracentrifugation studies to support scale up, development and characterization of gene therapy processes

Strong practical knowledge of downstream purification of mammalian and insect cell culture processes

Understanding of cGMP and regulatory requirements of biopharmaceutical manufacturing

Strong interpersonal and communications skills; written and oral

Ability to function in a fluid environment & balance priorities

Must be legally authorized to work in the United States now or in the future, without sponsorship

Must be able to pass a comprehensive background check, which includes a drug screening

Preferred

Prior viral vector purification experience is desired

Experience in scale up and scale down of purification processes

Experience with technology transfer, facility fit assessment, statistical analysis methodology and software (JMP or similar tools) is desired

Benefits

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Designated Paid Holidays

Retirement Savings Plan

Tuition Reimbursement

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount