Vertex ยท 2 months ago
Associate Director, Analytical Development, Biologics
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$159K/yr - $238K/yr
6+ years expVertex is a global biotechnology company that invests in scientific innovation. They are seeking an experienced leader to join their Analytical Development Team to lead biologics project CMC analytical development activities and collaborate with various functions to advance biologics projects from discovery to first license approval.
Computer Software
Responsibilities
Leads an analytical matrix team in execution of biologics analytical development
Partnering with internal and external labs in executing analytical development activities, including designing, planning, and executing all analytical activities that lead to successful IND/IMPD and/or BLA/MAA applications
Authors CMC sections of regulatory submissions. Ensures that all regulated work and documents conform to GMP standards
Proactive resource planning to align with established development strategy
Maintain a strong internal and external network for the execution of analytical activities
Qualification
Required
6-8+ years (PhD) or 9+ years (MS) in relevant discipline (analytical, biochemistry, molecular biology, biotechnology or related field) with progressive experience in technical leadership roles in the biotech industry, and specifically in the development of analytical control strategies
Strong experience in managing external CRO/CTO
Strong communication skills
Technical expertise in state-of art analytical methodologies
Problem-solving skills
Strong technical background in the area of analytical techniques commonly used in the analysis of biologics products
Data analysis and statistics used in product specification setting
Ability to work in a matrix team environment
Excellent communication skills and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts
Track-record in leading cross-functional matrix team
Excellent problem-solving skills in biologics development
Deep technical understanding of analytical methodologies, such as LC, iCE, CE-SDS, ELISA, PCR, particulates etc
Deep technical expertise to lead analytical method validation and analytical transfer, establish analytical control strategy, design stability programs and comparability studies
Experience authoring CMC sections of regulatory documents
Experience of Regulatory guidelines relevant to biologics development
Knowledge of cGMP requirements
A strategic thinker with a strong result orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
The ability to work in a dynamic, fast pace, matrix environment, manage priorities and maintain timelines for multiple projects
Benefits
Medical, dental and vision benefits
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)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase