MapLight Therapeutics, Inc. · 1 month ago
Associate Director, Formulation Development
Burlington, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$180K/yr - $200K/yr
5+ years expMapLight Therapeutics is a clinical stage biotech company focusing on drug discovery for central nervous system disorders. The Associate Director will lead drug product development initiatives in collaboration with external CDMOs, overseeing formulation development and GMP manufacturing activities to bring drug products from concept to patients.
BiopharmaBiotechnologyLife ScienceMedical
Responsibilities
Lead development of small molecule solid-oral dosage formulations from pre-IND to Phase 3 including:
Assess API physical and chemical properties as it relates to drug product manufacturability, performance and stability
Evaluate phase-appropriate formulation approaches and enabling technologies to achieve the target drug product profile
Design experiments to optimize the formulation and manufacturing process
Oversee formulation development and GMP manufacturing activities at CDMOs:
Lead DP endor section activities as necessary ad manage vendor relationship
Effectively communicate scope of work, timelines, and priorities and monitor the deliverables and performance as it relates to the project objectives
Drive review of batch records, protocols, reports, and other vendor documents
Provide technical expertise and guidance to troubleshoot development and manufacturing challenges
On-site presence for batch manufacturing activities at the CDMO as needed
Represent formulation development group in cross-functional team and effectively communicate project status and technical risks with appropriate solutions
Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS
Author/review internal technical reports and drug product sections of regulatory filings
You can participate and work effectively with multiple cross-functional teams
You have strong interpersonal skills and understand relationships are key to being successful
You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others
You’re a team player who is willing to roll-up your sleeves and get the job done
Qualification
Required
Degree in Chemistry, Chemical Engineering, Pharmaceutical Science, Material Science or equivalent with commensurate experience (BS 12+, MS 8+, PhD 5+)
Experience managing drug product activities at external CDMOs
Experience in solid oral drug product development from preclinical to late phase clinical development
Strong understanding of solid oral dosage formulation technologies, processes and equipment
Knowledge of chemical and physiochemical techniques used to characterize drug products
Knowledge of cGMP and current quality and regulatory guidelines
Demonstrated ability to problem solve, think strategically, and effectively communicate in a fast-paced environment
Ability to self-motivate and work independently
Benefits
Annual bonus opportunity
Medical
Dental
Vision
Life and AD&D
Short term and long term disability
401(K) plan with match
Stock options
Flexible non-accrual paid time off
Parental leave
Company
MapLight Therapeutics, Inc.
Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).
51-200 employees
H1B Sponsorship
MapLight Therapeutics, Inc. 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 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$640.6MKey Investors
Michael J. Fox Foundation
2025-10-27IPO
2025-07-28Series D· $372.5M
2023-10-30Series C· $225M
Leadership Team
Vishwas Setia
Chief Financial Officer
Recent News
2026-01-11
2026-01-06
Company data provided by crunchbase