Analytical Development Principal Scientist

Vertex Pharmaceuticals Inc (US); United States; On-site; USD 141,000 - 211,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Total Rewards benefits

Job summary

Vertex Pharmaceuticals Inc is seeking an experienced scientist to lead analytical development for drug substance process control strategies across clinical and commercial phases.

You will collaborate with CMC, set specifications, and oversee analytical method development while engaging with external contract labs to ensure compliance and robust data for regulatory submissions.

Qualifications

• Experience in development of drug substance analytical control strategies.
• Familiarity with regulatory guidelines (ICH, FDA, USP) and QbD.
• Strong communication and collaboration across multifunctional teams.

Responsibilities

• Design and oversee drug substance process development analytics across all development phases.
• Set specifications for drug substances, intermediates and starting materials.
• Identify IPC issues and develop appropriate analytical methods.
• Coordinate with contract manufacturing and testing labs for analytics.
• Develop and review regulatory submission source documents.
• Present findings and communicate analytical solutions to teams.

Skills

Control strategy development

QbD principles

cGMP knowledge

Analytical method development

Cross-functional collaboration

Project management

Education

Ph.D. in Chemistry/Analytical

MS in Chemistry with 7+ years experience

BS in Chemistry

Job description

Vertex is seeking an experienced scientist eager to help develop cutting-edge small molecules and the science underpinning the analytical control of their syntheses. As a member of the Drug Substance Control Strategy team in Analytical Development, this role will support synthetic drug development programs at Vertex with a focus on small molecule drug substance process and control strategy development across clinical and commercial-enabling phases. Specifically, the individual will oversee and execute experiments to develop the overall control strategy for novel drug substances, collaborate closely with associated CMC functions, and act as a subject matter expert liaison with our global network of external drug substance manufacturing and development vendors. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success.

Key Duties and Responsibilities

• Collaboratively design and oversee drug substance process development analytical activities across all phases of development, including late phase development following Quality by Design (QbD) principles
• Serves as subject matter expert for setting and justifying drug substance, intermediates, and starting materials specifications with the understanding of clinical study design, supporting toxicology studies, and CMC processes and applicable regulatory guidelines
• Identify critical in-process-control issues and develop appropriate IPC methods
• Serve as the subject matter expert for drug substance analytical development with contract manufacturing and testing labs
• Develop analytical methods, suitable for progressive stages of pharmaceutical development
• Justify and set retest period, storage, and shipping conditions for starting materials and intermediates
• Understand chemical development and solid-state development to identify and document critical factors that impact quality, method performance, or associated analytical development activities
• Develop and review source documents for regulatory submissions
• Present to cross-functional teams and effectively communicate critical analytical issues and solutions

Knowledge and Skills

• Excellent verbal and written communication skills are essential
• Experience and/or working knowledge of control strategy development, spike / purge studies, drug substance QbD process development
• Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines)
• Skilled in modern analyses for small molecule pharmaceuticals, particularly chromatography
• The ability to work successfully in both a team/matrix environment as well as independently
• The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects

Education and Experience

• Ph.D. with 4+ years of relevant analytical development experience, particularly focused on development of novel small molecule drug substances
• Exceptional candidates with MS degree and 7+ years or BS degree and 10+ years of high-level experience will also be considered
• Background in, or good understanding of modern synthetic organic chemistry, as well as of the drug substance development process, process chemistry, and pharmaceutical manufacturing, and their interrelationship with analytical development

Pay Range

Pay Range: $140,800 - $211,200 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

On-Site Designated Flex 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.

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 and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. 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 IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters 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 16 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 LinkedIn, Facebook, Instagram, YouTube, and X.

We believe our culture is one of Vertex's greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.