Massachusetts Green Jobs

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, or improving patient diagnostics and therapies, we are here to support them.

When you join the team at Thermo Fisher Scientific, you’ll do important work. Things like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. You’ll also have the opportunity for continual growth and learning in an environment that will support your development.

We are seeking an energetic and enthusiastic individual with strong communication, leadership, technical and operational skills to join our growing Process Development team.

Job Title: Head of Analytical Development

Location/Division Specific Information: US - Massachusetts - Plainville

How will you make an impact?

In BioProcess Sciences group our goal is to develop, characterize and scale-up bioprocesses for robust manufacture of viral vectors to help our clients deliver lifesaving therapies to patients.

As the head of analytical development (AD), You will plan, design, execute, and document analytical testing and method transfer activities. You will also act as domain expert in analytical development for viral vector while supporting detailed transfer and development of analytical methods from clients into Bioprocess Sciences lab. You will also be supporting assay transfer out to the QC for cGMP testing.

This is a hands-on position. The ideal candidate shall have excellent lab skills, strong documentation skills, ability to analyze and summarize data to draw conclusions, make recommendations, and tight-knit collaboration skills.

What will you do?

· Responsible for the design and execution of phase-appropriate development/testing strategies including PCR based assays, immunoassay used for quantitation, and characterization of viral vectors (Adeno-associated virus, lentivirus and other capsids).

· Lead transfer and establishment of already-developed analytical assays, particularly, titer using PCR, capsid titer using ELISA, % full capsid using Capillary electrophoresis, SDS-PAGE, HPLC, Analytical Ultracentrifugation, size/aggregate characterization using light scattering, and process impurities using dPCR/qPCR and Elisa.

· Lead a team of scientists and associates responsible for bioassay method development and phase-appropriate qualification for a portfolio of programs.

· Develop platform assays for gene therapy characterization.

· Collaborate across the larger Thermo Fisher Scientific network on novel technologies (such as Raman or other process analytical technology tools) for real time characterization of gene therapy molecules and developing automation workflows (Pharma 4.0).

· Responsible for in-house GLP/GCLP infrastructure, systems and procedures to ensure adequate thorough laboratory practices & regulatory requirements for analytical activities.

· Define priorities and objectives for staff to ensure timely completion of tasks as per project timelines. Interact with clients, ensures accurate data and presentations to the clients.

· Assist in preparing detailed analytical development report to support manufacturing and regulatory requirements.

· Support sourcing, purchase, installation, startup and calibration and maintenance of analytical testing equipment.

· Stay updated with literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers.

· Collaborate with process development groups to effectively support process development/characterization testing and QC team for assay transfer for GMP testing.

· Lead Practical Process Improvement (PPI) initiatives

How will you get here?

Education

· B.S. in Chemistry, Biochemistry, Engineering or related field with 12 yrs., Masters with 8 yrs., or Ph.D. with 5 yrs. of industrial experience including leadership experience.

Experience and skillset

· Experience with AAV, LV and Gene and/or cell therapy preferred.

· Track record with analytical development with deep expertise with assay development in PCR, ELISA, CE, SDS-PAGE and other relevant assays.

· Experience with analytical method development, across various platforms, (e.g.ELISA, HPLC, DLS, Raman, Chromatography, etc.) including quantitation of therapeutic proteins in biological matrices, metabolite identification and impurity profiling.

· Experience handling third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred.

· Shown deeply understanding of global regulatory requirements including GLP, GCP and the clinical trial process.

While performing the duties of this job, the employee:

· Will work in a dynamic environment and balance multiple priorities simultaneously!

· Will be self-motivated and proactively drive efficient execution.

· Will be encouraged to learn new software, processes, and tools quickly!

· Will use outstanding equipment and instrumentation in daily manufacturing.

· Will demonstrate flexibility with changes to working environment and deliver high quality results.

· Will critically review processes and recommend improvements to supervisor/manager.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.