MSAT Technology Transfer Lead at Thermo Fisher Scientific

Plainville, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

B.S. in Chemistry, Biochemistry, Engineering or related field with 12 years of industrial experience including leadership experience; or Master's with 8 years; or Ph.D. with 5 years
10+ years of hands-on experience in Manufacturing Sciences for AAV, lentivirus, and gene therapy preferred; minimum 5 years required
5+ years of leadership experience managing scientific/technology teams required
Preferred experience building, implementing, and managing a Manufacturing Sciences function with exposure to both USP and DSP strategies
End-to-end technical understanding of gene therapy manufacturing processes required; demonstrated in-depth expertise in downstream processing (DSP) is a plus
Excellent resource management and prioritization skills
Outstanding ability to analyze, interpret, and synthesize data; define problems; establish facts; draw valid conclusions; and make decisions
Thorough understanding of regulatory guidelines (FDA, EMA, and other relevant authorities)
Excellent troubleshooting skills with the ability to resolve complex technical issues
Strong interpersonal and communication skills, both verbal and written
Ability to work regular business hours and, when needed, outside business hours (including evenings, weekends, and holidays)
Ability to apply Good Manufacturing Practice (GMP) principles and knowledge of pharmaceutical processes, equipment, instrumentation, and procedures
Presence on the manufacturing floor

Responsibilities

Lead technology transfer to GMP from clients or the internal development team, including process/facility gap assessments and drafting/reviewing GMP documents (batch records, tech transfer protocols, sampling plans)
Lead the tech transfer team; build and develop a team of scientists and engineers to drive successful tech transfer
Collaborate closely with GMP Manufacturing, Quality Control, Quality Assurance, Engineering, and Development to ensure a successful transfer that yields a robust process
Collaborate closely with the site Process Validation team to ensure PPQ readiness; co-author PPQ protocols and reports, ensuring GMP compliance
Serve as the subject matter expert across gene therapy process and analytical methods
Drive quality management by leading deviations, leading RCA/CAPAs, and performing change controls related to process, materials, and equipment
Drive process, quality, and operations risk assessments and change controls for new product introductions

Skills

GMP

Technology Transfer

Tech Transfer Protocols

Batch Records

Sampling Plans

Process Validation

CMC Development

MSAT

Viral Vectors

Gene Therapy

Team Leadership

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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