Senior Scientist, Formulation Development
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 motivated and talented Senior Scientist to join the formulation development group in the CMC department. Reporting to the Director of Formulation Development, the desired candidate will manage drug product development activities in collaboration with external CDMOs for MapLight’s pipeline programs. This is a great opportunity to join a small team and grow in a fast-paced environment to bring drug products from initial concept to patients.
- Develop 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 and manage formulation development and GMP manufacturing activities at CDMOs:
- Effectively communicate scope of work, timelines, and priorities to CDMOs and monitor the deliverables and performance as it relates to the project objectives
- Drive review of batch records, protocols, reports, and other vendor documentation
- Provide technical expertise and guidance to troubleshoot development and manufacturing challenges
- On-site presence for batch manufacturing activities at the CDMO as needed
- Collaborate with cross-functional team to identify project and technical risks and come up with appropriate solutions
- Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS
- Author and 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.
- Degree in Chemistry, Chemical Engineering, Pharmaceutical Science, Material Science or equivalent with commensurate experience (BS 8+, MS 5+, PhD 3+)
- Experience managing drug product activities at external CDMOs
- Experience in solid oral drug product development, with extended-release formulation experience preferred
- 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
- Local candidates who can occasionally work from our office in Burlington, MA are preferred.
- Ability to travel up to 25% of time
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.