Analytical Science and Technology Sr. Scientist

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Vertex is seeking a talented analytical chemist for late-stage product development in a commercial setting, with emphasis on Process Excellence, working with CMOs and a diverse team of scientists in a global organization. You will develop, implement and troubleshoot analytical methods in pharmaceutical production, influencing colleagues with strong communication and negotiation skills.

The role requires experience in method transfers, data analysis, and process verification, in a collaborative,

Qualifications

• Bachelor's, Master's, or PhD in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or related natural science.
• Experience developing analytical methods and transferring to CMOs.
• Knowledge of cGMPs, ICH guidelines, and CMC regulatory considerations.

Responsibilities

• Manage method transfers for small molecule drug product and drug product intermediate to CMOs.
• Author/review documentation to support commercial products.
• Manage commercial QC testing at Vertex’s Contract Testing Organizations.
• Conduct technical review of analytical data (QC release and stability testing).
• Lead analytical OOS/OOT investigations and assist process investigations.
• Perform statistical analysis for continued process verification.
• Coordinate with MS&T, Supply Chain, Quality, and Regulatory to support manufacturing.
• Manage analytical method lifecycle (method performance trending, process improvement, change control).

Skills

Analytical chemistry

Root cause analysis

HPLC/GC

cGMP knowledge

Data analytics

Technical writing

Team collaboration

Education

Bachelor's/Master's/PhD in Chemistry or related field

Job description

Job Description Job Description Vertex is seeking a talented, experienced analytical chemist for late-stage product development in a commercial setting with an interest in Process Excellence. Working directly with our contract manufacturing organizations and a highly diverse group of scientists at Vertex you will solve complex problems encountered in commercial production/manufacturing of drug products. You will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design and Continuous Manufacturing. To be considered for this position the applicant will need to be a collaborative, experienced and competent analytical chemist with a history of developing, implementing and troubleshooting analytical methods in the pharmaceutical industry, with the ability to influence colleagues, and possessing strong communication and negotiation skills. Experience in developing process maps and implementing sustainable process improvements is desired.

Key Responsibilities

• Manage method transfers for small molecule drug product and drug product intermediate to various CMOs to support late-phase and commercial projects
• Author/review documentation to support new and existing commercial products (methods, SOPs, transfer protocols/reports, technical reports, etc.)
• Manage commercial QC testing at Vertex’s Contract Testing Organizations
• Conduct technical review of analytical data (QC release and stability testing)
• Lead analytical OOS/OOT investigations and assist process investigations
• Perform statistical analysis for continued process verification
• Partner with MS&T, Supply Chain, Quality, and Regulatory to lead the coordination of activities in support of Vertex's commercial drug product and drug product intermediate manufacturing
• Manage analytical method lifecycle (method performance trending, process improvement, change control)

Knowledge and Skills

• Experience in an analytical development or technical operations role, supporting new product development and/or commercialization
• Problem-solving/root cause analysis for analytical related issues
• Experience with chromatography methods such as HPLC, GC, and other common analytical techniques used in pharmaceutical analysis
• Experience with compendial methods for analysis (e.g. KF, elemental impurity testing, and identification by spectroscopy)
• Knowledge of cGMP’s (e.g. Quality Control), ICH guidelines and associated CMC regulatory considerations in a pharmaceutical setting
• Proficient with data analytics and visualization tools
• Strong communication and technical writing skills
• The ability to work successfully in both a team/matrix environment as well as independently
• Demonstrated ability to effectively manage project(s), and flexibility to accommodate changes in responsibilities or project priorities

Education and Experience

• Bachelor's, Master's, or PhD in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or other natural science
• Typically requires the following, or the equivalent combination of education and experience: PhD and 0-3 years, or Master's and 3+ years, or Bachelor's and 6+ years.

Pay Range: $120,000 - $180,000

Disclosure 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: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: 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.

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 [e-mail]

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.