Director, Analytical Development

Title: Director, Analytical Development

Location: Burlington, MA

Job Description:

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

 

What You’ll Do: We are seeking a highly motivated and experienced Director of Analytical Development to lead and build our Drug Product analytical function. This role is critical in supporting the development of our novel therapeutic candidates, with a focus on drug product analytical development and product characterization. The ideal candidate will thrive in a fast-paced, collaborative startup environment and bring deep technical expertise in analytical sciences for small molecules.

 

Responsibilities:

 

Strategic Leadership:

 

Develop and execute the analytical development strategy for drug product (solid oral dosage formulations) in alignment with overall CMC and program goals.

 

Method Development and Validation:

 

Lead the design, development, qualification and validation of analytical methods to support formulation development, stability studies and release testing.

 

Cross-Functional Collaboration:

 

Partner closely with formulation scientists, process development, supply chain, quality, regulatory, and external CDMOs to ensure robust analytical support across the product lifecycle.

 

Team Building:

 

Build and manage a high-performing analytical team, including hiring, mentoring, and developing scientist and technical staff.

 

Regulatory Support:

 

Author and review analytical sections of regulatory submissions (IND, IMPD, BLA/NDA/MAA), and support regulatory interactions as the analytical subject matter expert.

 

Technology and Innovation:

 

Evaluate and implement new analytical technologies and approaches to enhance product understanding and accelerate development timelines.

 

External Oversight:

 

Manage outsourced analytical activities at CROs/CDMOs ensuring quality, timelines and scientific rigor.

 

Qualifications:

 

• PhD. in Analytical Chemistry, Pharmaceutical Sciences, or related field with 8+ years of industry experience, or M.S. with 12+ years or B.S. with 15+ years.


• Proven track record in analytical development for drug product (formulation), ideally in a startup or biotech setting.


• Deep understanding of analytical techniques such as HPLC, UPLC, LC-MS, Particle Size Analysis, Dissolution, and Compendial Methods.


• Experience with the development of discriminatory dissolution methodology and IVIVC studies is a plus.


• Strong knowledge of ICH guidelines, and phase appropriate GMP and regulatory expectations for analytical methods and stability programs.


• Ability to problem solve, manage priorities, and maintain timelines for multiple projects.


• Excellent communication and organizational skills with an ability to work productively and independently within a team or matrix environment.


 

 

Location: This is a hybrid position three days per week onsite at our office in Burlington, MA.

 

Travel: Ability to travel up to 25% of time as needed

 

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.