20 Best 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…
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
Senior Scientist, Analytical Development- Mutagenic Impurities
Vertex Pharmaceuticals —Boston, MA
Vertex is seeking a talented scientist eager to help develop both cutting-edge small molecule pharmaceuticals and the science underpinning the analytical…
Estimated: $75.1K - $95.1K a year
3d
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…
Antibody Licensing Scientist
Biocytogen Boston —Waltham, MA
Communication Skills: Excellent verbal and written communication skills, with the ability to convey complex technical information to a non-technical audience.
$85,000 - $110,000 a year
Quick Apply
15h
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
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…
Quick Apply
6d
Weights and Research Coordinator
R+L Carriers —Canton, MA
R+L Carriers offers an excellent compensation and comprehensive benefits package that includes Medical/Dental/Vision Insurance, 401(k) Retirement Plan with…
Chemical Engineering Scientist, Crystallization
Vertex Pharmaceuticals —Boston, MA
Data analysis; statistical design of experiments; QbD concepts, and fluency with the use of mechanistic models to develop and optimize multi-step chemical…
R&D Chemist
Armstrong Pharmaceuticals —Canton, MA
The employee must occasionally work near moving mechanical parts and is occasionally exposed to wet, humid conditions, and extreme heat.
$70,000 - $80,000 a year
Quick Apply
Research Scientist (Contract) 22311
Vertex Pharmaceuticals —Boston, MA
The group uses a variety of chemical biology, cell and molecular biology approaches, automation platforms, and automated liquid handling to make fundamental…
$50 - $60 an hour
2h
Senior Biostatistician II, Biometrics (HYBRID)
Vertex Pharmaceuticals —Boston, MA
Within assigned area, designs, develops and executes the technical/statistical infrastructure for the conduct and evaluation of clinical trials, observational…
Estimated: $91.9K - $116K a year
Senior Manager, Quality Analytical Microbiology Cell and Gene (Hybrid)
Vertex Pharmaceuticals —Boston, MA
Ability to independently lead cross-functional teams and represent the Quality unit, and to mentor and guide less experienced colleagues, skilled at…
Estimated: $96K - $122K a year
Senior Sponsored Research Administrator
Actalent —Boston, MA
Works with Financial Analysts and others as necessary to reconcile information/reports and provide investigators with regular financial status reports in user…
$85,000 - $95,000 a year
Quick Apply
3d
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
3d
Research Scientist 1
MIT —Cambridge, MA
REQUIRED: Ph.D in physics; at least two years of postdoctoral research in research areas related to optical systems and AI, preferably in the field of…
Estimated: $59.1K - $74.8K a year
16h
Product Development Scientist
Medica Corporation —Bedford, MA
The scientist role is expected to be proficient in the use of laboratory methods and to develop an understanding of the documentation and validation processes…
Estimated: $46.3K - $58.6K a year
Quick Apply
7d
Associate Scientist, Translational Editing
Lilly —Cambridge, MA
Bachelor's and/or Masters degree in biology or a related field. Experienced in molecular biology, including, PCR, qPCR, ddPCR, protein analysis (WES, JESS,…
Estimated: $80.7K - $102K a year
12d
Scientist - Discovery Neuroinflammation Group
Pfizer —Cambridge, MA
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.
$74,900 - $124,800 a year
8h

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MSAT Principal Scientist, Aseptic Control

Vertex Pharmaceuticals - Boston, MA

Apply Now

Job Details

Full-time

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.

Scientist jobs in Cambridge, MA

MSAT Principal Scientist, Aseptic Control

Applications Scientist - NMR

Senior Scientist, Analytical Development- Mutagenic Impurities

Wetland Scientist

Staff Scientist- Early Childhood Development

Antibody Licensing Scientist

Policy Advisor

R&D Manager - New Markets

Weights and Research Coordinator

Chemical Engineering Scientist, Crystallization

R&D Chemist

Research Scientist (Contract) 22311

Senior Biostatistician II, Biometrics (HYBRID)

Senior Manager, Quality Analytical Microbiology Cell and Gene (Hybrid)

Senior Sponsored Research Administrator

Director, Sensor Design & Development

Research Scientist 1

Product Development Scientist

Associate Scientist, Translational Editing

Scientist - Discovery Neuroinflammation Group

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