Associate Director, Material Science
About the role
The Associate Director, Materials Science will lead scientific strategic leadership for small molecule drug development programs, with accountability for material understanding, solid-state control, and material-related risk management from IND through NDA and commercialization. This role plays a critical part in ensuring robust solid-state form selection, particle and material control strategies, and successful technology transfer to clinical and commercial manufacturing.
Responsibilities
Contribute and execute material science strategy for small molecule drug substance and drug product programs, including solid-state form selection (salt, polymorph, amorphous), particle engineering, and excipient compatibility.
Serve as subject matter expert in solid-state chemistry, physicochemical characterization, and structure–property–process relationships.
Design, interpret, and oversee material characterization using techniques such as XRPD, DSC, TGA, DVS, spectroscopy, microscopy, and particle size analysis.
Define critical material attributes (CMAs) and their linkage to formulation performance, process robustness, and product quality.
Establish material control strategies to ensure consistent manufacturability and long-term product stability.
Define the initial material science approach to support IND-enabling activities, including solid-state form screening and selection.
Lead early material risk assessments (e.g., polymorphism, hygroscopicity, particle size sensitivity) and mitigation strategies.
Support prototype formulation development (e.g., IR tablets, capsules) by providing material selection rationale and handling guidance.
Support transfer of material knowledge from discovery to development and clinical manufacturing teams.
Contribute to IND CMC sections related to material characterization, form selection, and control approaches.
Lead comprehensive material characterization and comparability assessments to support scale-up, validation, and commercial readiness.
Define and justify commercial material specifications and acceptance criteria.
Author, review, and approve NDA/MAA CMC sections related to materials, solid-state control, and lifecycle management.
Support health authority interactions and responses related to material science topics.
Lead materials science activities for technology transfer from development to clinical and commercial manufacturing sites (internal and CMOs).
Partner with MSAT, Process Development, Manufacturing, Quality, and External Manufacturing to ensure successful scale-up and site transfer.
Support engineering, PPQ, and validation batches, providing scientific oversight for material-related performance.
Identify, assess, and mitigate material-related risks during scale-up and validation.
Lead or support investigations into material-driven deviations or performance issues during tech transfer and commercial manufacturing.
Act as a key materials science representative on cross-functional CMC and project teams.
Influence program strategy through data-driven recommendations and risk-based decision-making.
Qualifications
Education: PhD in Materials Science, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field or MS with substantial relevant industry experience.
Experience: Typically 8–12+ years of experience in pharmaceutical or biotech drug development, with a strong focus on small molecule programs.
Demonstrated experience supporting oral solid dosage forms (preferred).
Proven track record contributing to IND and NDA submissions.
Experience with technology transfer and commercial manufacturing (internal or CMOs).
Technical Expertise: Solid-state chemistry, polymorphism, salt selection, and particle engineering; Material characterization techniques and data interpretation; Understanding of formulation development, scale-up, and GMP manufacturing; Familiarity with QbD, risk assessments, and lifecycle management.
Strong written and verbal communication skills, including regulatory technical writing.
Ability to lead without authority and influence cross-functional teams.
Strategic thinker with strong problem-solving and decision-making skills.
Benefits
Comprehensive medical, dental, vision, prescription drug coverage
Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
A generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Pay
Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity.
Schedule
N/A