About this role
Job Description
Employer: Vertex Pharmaceuticals Incorporated
JOB TITLE: Analytical Development Scientist
LOCATION: 316 - 318 Northern Avenue, Boston, Massachusetts 02210
OPENINGS: 1
DUTIES:
- Perform a variety of well-defined, supportive functions including leading design and execution of analytical procedures that support development of cell therapy products.
- Develop, qualify and validate new test methods for characterization, purity and potency of hESCs and iPSC derived cell intermediates and drug products.
- Rapidly incorporate and adapt longstanding methods to the most recent FDA guidelines.
- Generate hypotheses and creative solutions to pursue Project goals, set new experimental directions, and overcome obstacles.
- Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
- Successfully transfer complex cell-based assays to QC and provide SME support for qualification and validation, including authoring and reviewing of protocols and reports.
- Develop and manage analytical commercial capabilities and strategies to ensure robust and compliant analytical methods and testing for commercial requirements.
- Provide technical recommendations broadly within the company regarding own field and play a key Project Role.
REQUIREMENTS: Employer will accept a Masters's degree, or foreign equivalent, in Pharmacology or a related field and 4 years of experience in the job offered or in an Analytical Development Scientist-related occupation.
Alternatively, employer will accept a Ph.D. degree, or foreign equivalent, in Pharmacology or a related field and 2 years of experience in the job offered or in an Analytical Development Scientist-related occupation.
Position requires demonstrable experience in the following:
Reliable and consistent technical skills on relevant Cell therapy analytical assay platforms including:
Capsid Enzyme-linked immunosorbent assay (ELISA), AlphaLISA and Western blotting techniques
FlowCAM analysis
Optical Coherence Tomography
Islet Perifusion system
Droplet digital polymerase chain reaction (ddPCR) and qPCR for copy number variation
Flow Cytometry
hESC expansion and Cell culture, and o Cell-based potency assays.
Theoretical and practical knowledge of developing characterization assay including cell counting assays for cells encapsulated in immunoprotected device. Experience with developing and qualifying functional potency assays including glucose stimulated insulin secretion assay for beta cells encapsulated in immunoprotected device. Experience with expansion and differentiation of hESCs to beta cell islets and experience with culturing multiple mammalian cell lines. Technical knowledge of IND enabling GLP animal toxicology study. In-depth knowledge of commercial biological assay development, validation, transfer, and troubleshooting compliant with GMP operations, supporting product development and Commercialization. Knowledge of spent media analysis using platforms including Flex2, Rebel, and Cedex. Technical knowledge of IND and BLA filing documents for cell therapy-based drug products. Contributing to CMC strategy for regulatory filing for late phase drug development. Effectively collaborate with an integrated cross-functional team to perform tech transfers, root cause analysis studies and training runs. Provide analytical oversight for CDMO, CRO, CTO, and third-party testing to support commercial manufacturing (In-Process Controls and release).
Rate of Pay: $113464.00 - $132400.00
CONTACT: Send Resume to [email protected]. Reference 12140.434. EOE.
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Pay Range:
$102,800 - $154,200Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
Other facts
About Vertex Inc.
The rapid changes taking place in today’s global business, technology, and regulatory environments are having a compounding effect on the complexity of indirect tax management and putting more pressure on the corporate tax function than ever before. This complexity demands intelligent solutions that enable businesses to satisfy tax obligations and support growth opportunities.
The Trusted Leader in Tax Technology
We're Vertex (VERX). A pioneer in tax automation for more than 40 years. We proudly serve over 4,000 customers worldwide with distinction and provide comprehensive tax solutions that enable global businesses to transact, comply and grow with confidence.
Our software, content and services address the increasing complexities of global commerce and compliance by reducing friction, enhancing transparency and enabling greater confidence in meeting indirect tax obligations. As a result, our software is ubiquitous within our customers’ business systems, touching nearly every line item of every transaction that an enterprise can conduct. Our software is fueled by over 300 million data-driven effective tax rules and supports indirect tax compliance in more than 19,000 jurisdictions worldwide.
We partner with the world’s most respected companies and harness their strengths to deliver the best tax technology solution to businesses across the globe. We integrate with key technology partners that span ERP, CRM, procurement, billing, POS and e-commerce platforms. We also work closely with over 50 tax, accounting and consulting firms to provide the integrated tax technology solutions.
Our culture is the foundation of everything we do, guided by a common purpose to build trusted relationships at work, in business and in our communities. We strive to be a values-driven employer of choice who attracts, retains and inspires talented professionals to achieve their full potential. We employ over 1,100 full-time professionals today in the US, Europe and Brazil.
What you'll do
- The Analytical Development Scientist will lead the design and execution of analytical procedures for cell therapy products and develop new test methods for characterization and potency. They will also transfer complex assays to QC and provide support for qualification and validation.
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