20 Best principal scientist jobs in Cambridge, MA (Hiring Now!)

MSAT Principal Scientist, Aseptic Control
Vertex Pharmaceuticals —Boston, MA
Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device…
Estimated: $163K - $207K a year
Scientist II, Protein Expression Technologies and Production (Discovery)
Marengo Therapeutics Inc —Cambridge, MA
M.S. or PhD in Biochemistry, Molecular Biology, Cell Biology or a closely related field and 5+ years experience in Molecular Biology, mammalian cell line…
Estimated: $120K - $152K a year
Quick Apply
PLM Analyst/Scientist
Pace® Analytical Services —Woburn, MA
Bachelor's degree in Geology, or a closely related field. Visual acuity to read, to determine color, depth perception and field of vision.
Estimated: $45.9K - $58.1K a year
Policy Advisor
Technical Assistance Collaborative —Boston, MA
Bachelor’s degree in a field related to the type of consultation TAC provides (social work, psychology, public health, or related health profession) required.
$100,000 a year
Quick Apply
Applications Scientist - NMR
JEOL USA, Inc. —Peabody, MA
Extensive knowledge of liquids NMR applications and methods, knowledge of solid-state NMR a plus. Provide technical support to customers, sales, and marketing…
From $80,000 a year
Quick Apply
Service Technician for Flow Cytometer
Certified Genetool —Boston, MA
The Field Service Engineer is expected to proficiently troubleshoot, repair, and ensure optimal instrument performance while completing installations, repair,…
Estimated: $52.1K - $66K a year
Quick Apply
R&D Manager - New Markets
The Haartz Corporation —Acton, MA
Identify suitable raw materials and design appropriate constructions and manufacturing processes by understanding the basic performance requirements of the end…
Estimated: $73.2K - $92.7K a year
Quick Apply
13d
Principal Biostatistician
Vertex Pharmaceuticals —Boston, MA
Conducts advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations,…
Estimated: $122K - $155K a year
Specialist, International Pharmacovigilance
Vertex Pharmaceuticals —Boston, MA
Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. From medical, dental and vision benefits to generous paid…
$82,400 - $123,600 a year
7d
Senior Clinical Trial Manager (Rare Disease, Immunology)
Actalent —Boston, MA
Leads and manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, US and Ex US regulatory guidelines…
$70 - $86 an hour
Quick Apply
7d
Principal Scientist, Protein Sciences
Treeline Biosciences —Watertown, MA
Specifically, you will impact the target enabling strategy and design and implement gene-to-protein workflows to deliver high-quality protein for use in SAR…
Estimated: $157K - $199K a year
Quick Apply
Client Recovery Advisor (CRA)
Aware Recovery Care —Melrose, MA
At Aware Recovery Care, you will give clients the tools to navigate their daily lives and help them on their own unique path to recovery.
$20 - $26 an hour
Quick Apply
Wetland Scientist
Hancock Associates —Danvers, MA
Professional Wetland Scientist (PWS) license required. This role involves about 25% field work, 60% office work, and 15% conservation commission meeting…
$70,000 - $90,000 a year
Quick Apply
Staff Scientist- Early Childhood Development
Boston Children's Hospital —Boston, MA
Daily project management & implementation of evaluation design, data collection & management, data analysis, and reporting; resource delegation, team management…
Senior Manager, GCP Operational Quality Assurance R&D (Remote)
Vertex Pharmaceuticals —Boston, MA
For assigned programs/ studies, leads quality issue investigations, root cause analysis and CAPA development and assist study teams in implementing corrective…
$132,880 - $199,320 a year
1h
Principal Scientist, Global Biologics
Takeda Pharmaceutical —Boston, MA
You will also contribute to multiple projects, acting as senior scientific consultant, may be a project team leader or providing key technical knowledge to a…
$149,100 - $234,300 a year
3d
Scientist, Chromatographic Separations, Early Oncology
AstraZeneca —Waltham, MA
Bachelors or Masters degree in analytical chemistry or related field. This hands-on laboratory position offers the opportunity to contribute to our mission of…
Estimated: $80.3K - $102K a year
3d
Scientist - Discovery Neuroinflammation Group
Pfizer —Cambridge, MA
Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process…
$74,900 - $124,800 a year
7d
Director, Sensor Design & Development
Medica Corporation —Bedford, MA
The Director, Sensor Design and Development leads a team of scientists to conduct analytical research and development for state of the art potentiometric,…
From $160,000 a year
Quick Apply
10d
Process Chemistry Senior Principal Scientist
Vertex Pharmaceuticals —Boston, MA
The Sr. Principal Scientist Process Chemistry will lead/participate in cross-functional technical teams within their field of expertise.
Estimated: $158K - $200K a year

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MSAT Principal Scientist, Aseptic Control

Vertex Pharmaceuticals - Boston, MA

Apply Now

Job Details

Full-time Estimated: $163K - $207K a year

Qualifications

CGMP
Management
Contamination control
Manufacturing
Root cause analysis
Communication skills
10 years

Full Job Description

Job Description

The Principal Scientist, Aseptic Control, is recognized as having expertise in the principals and application of sterile and low bioburden processing technologies and providing technical support for manufacturing of cell and gene therapy (C&GT), small molecule, and combination medical device programs within cCMP manufacturing. This aseptic processing SME will partner with stakeholders to define strategies for microbial control of activities such as gowning, facility monitoring programs (EM, Water, Gases, etc.), disinfectant efficacy, aseptic processing simulations, filtration, particulate control, risk assessments, and will ensure the control strategies comply with industry guidance. The individual will interface with internal and external manufacturing sites to support the maintenance of critical cGMP aseptic activities and will also assist in significant manufacturing investigations involving aseptic and/or low bioburden processing and facility monitoring programs. This role will report to the Director of Aseptic Control within Manufacturing Science and Technology (MSAT) Process team for Biopharmaceutical Sciences and Manufacturing Operations (BSMO). This position will be based in Vertex’s corporate headquarters in Boston, MA (Hybrid eligible working arrangement where flexibility in on-site working is available).

The incumbent will work cross-functionally with colleagues in the BSMO/CMSC, Regulatory, Quality and R&D of Vertex on the design of processes and technologies required to produce aseptic and/or low bioburden drug products to successfully commercialize an exciting and diverse portfolio of innovative pipeline programs. In addition, the successful candidate will support the implementation of risk-based design and controls for low bioburden process operations for production of drug substance/intermediates for manufacturing. The successful candidate will be experienced in the field of aseptic process technologies (drug product and drug substance) including simulations, filter integrity, microbial testing strategies, microorganism characterization, aseptic technique and clean room facility monitoring programs.

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

Key Responsibilities:

Provide technical input into environmental/facility/process monitoring program deviations and contamination events to determine impact to batch disposition and design/implement effective corrective and preventative actions to prevent future disruptions.
Strong collaboration in the resolution of manufacturing investigations related to aseptic control events
Support the design and implementation of risk-based approaches and strategies designed to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites.
Support of regulatory submissions and pre-approval inspection activities related to contamination control and prevention and control strategies for aseptic operations.
Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.
Establish processes and capabilities to provide technical stewardship of control strategies post-approval including establishing performance monitoring capability and troubleshooting/ out of conformance event resolution. This will involve partnering closely with external contract manufacturing and testing organizations to establish processes to monitor test process performance and continuous improvement initiatives.
Adherence to the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations. Drive operational excellence, flawless execution and continuous improvement.

Required Qualifications:

At least 10+ years of experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products, and demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.
Deep understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and drug product manufacturing regulations and excellent written and verbal communication skills. Prior experience supporting drug product manufacturing activities across multiple modalities (e.g., sterile dosage form, devices, etc.) and design of sterility assurance and facility monitoring programs is desired.
Experience with root cause analysis and deviation management
A proven ability to work seamlessly across teams and develop excellent relationship and partnerships with peers is critical to success in this role.
Demonstrated understanding of the principles and applications associated with commercial manufacturing operations.
Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations
Strong knowledge of cGMP requirements
A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide
Excellent team player and be able to build and sustain organization respect and trust at all levels
Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
Resilient and able to work well in a demanding, fast paced entrepreneurial environment
Sound judgment and business acumen with personal versatility and flexibility as business and team evolve Keeps current on professional knowledge, expertise and best practice; influential in the external environment in the area of aseptic processing and participates in industry consortia/ conferences relevant to the field.

principal scientist jobs in Cambridge, MA

MSAT Principal Scientist, Aseptic Control

Scientist II, Protein Expression Technologies and Production (Discovery)

PLM Analyst/Scientist

Policy Advisor

Applications Scientist - NMR

Service Technician for Flow Cytometer

R&D Manager - New Markets

Principal Biostatistician

Specialist, International Pharmacovigilance

Senior Clinical Trial Manager (Rare Disease, Immunology)

Principal Scientist, Protein Sciences

Client Recovery Advisor (CRA)

Wetland Scientist

Staff Scientist- Early Childhood Development

Senior Manager, GCP Operational Quality Assurance R&D (Remote)

Principal Scientist, Global Biologics

Scientist, Chromatographic Separations, Early Oncology

Scientist - Discovery Neuroinflammation Group

Director, Sensor Design & Development

Process Chemistry Senior Principal Scientist

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