Associate Director, CMC, Drug Product

Xenon Pharmaceuticals•Needham, MA

5d•Hybrid

About The Position

Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics. We are seeking an Associate Director, CMC, Drug Product, to join our team. This role will manage and oversee the early-stage assessment and formulation development of drug products for pre-clinical and early-stage Phase 1 and 2 clinical programs. The candidate will be a key member of highly collaborative internal Drug Product and CMC teams, primarily managing discovery and toxicology formulation, developability evaluation of candidate molecules, and Phase 1 and 2 formulation and manufacturing process development. This position reports to the Director, CMC, Drug Product and will be based out of our Boston, MA, USA in our Needham office. This role is a hybrid position, requiring a minimum of 2 days per week in the office.

Requirements

PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or a related discipline with at least 10+ years of relevant experience in a pharma or biotech environment. Candidates with a BSc or MSc and relevant experience will also be considered.
Experience in managing early-stage drug product development and manufacturing activities (first in human and proof of concept formulations), including oversight of external Contract Manufacturing Organizations (CMOs).
Strong background in powder based small molecule drug product development with experience on capsules, tablets, spray drying, granulation, blending, bottling and blistering.
Experience supporting discovery, non-clinical and toxicology formulation development including parenterals, solutions, suspensions, lipids/SEDDS/SMEDDS, amorphous or salt forms.
Experience contributing and developing CMC sections for regulatory filings (i.e. US and ex-US) is required.
In-depth knowledge of cGMP regulations, guidance, principles, and best practices related to drug product development and manufacture is required.
Experience with CDMO selection, management, contracting, and issue resolution.
Experience working with global CDMOs is required.
Excellent oral and written communication, leadership, and interpersonal skills, with the ability to build credibility and trust both inside and outside the company.

Nice To Haves

Experience developing solutions, suspensions, granules or powders for suspension, chewable tablets, buccal/sublingual tablets is a plus.
Experience with PK exposure modeling and drug developability is a plus.
Experience in developing formulations of small molecule parenteral dosage forms is a plus.
Experience developing and progressing enabled formulations such as spray dried dispersions, hot melt extrusion, lipid softgels, nano-formulations to the clinic is a plus.

Responsibilities

Lead non-clinical formulation and early phase clinical formulation and process development activities of small molecule drug products.
Effectively communicate with cross-functional teams to ensure CMC decisions support current and upcoming phases of drug development.
Manage activities related to early-stage formulation development including drug substance attribute profiling, developability assessments and executing plans for first in human phase 1 and phase 2 formulation development.
Provide updates to product development teams and program manager as required.
Manage and coordinate clinical trial material manufacturing and packaging for early-stage small molecule assets with assigned Clinical Supply colleagues.
Manage the selection of early-stage CDMOs while considering capabilities, capacities, redundancy and quality.
Partner with QA GMP colleagues as required.
Provide input for drug product stability programs and help select appropriate packaging for clinical development in collaboration with Analytical colleagues.
Evaluate, recommend, and manage qualified CROs and CDMOs for manufacturing drug products for discovery, non-clinical and toxicology formulations as well as for early phase clinical trials.
Collaborate with Quality Assurance to manage audits and inspections of CDMOs and on manufacturing investigations.
Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates.
Write, review and/or approve relevant documentation required to support drug development including batch records, specifications, development reports, development protocols and other necessary documentation.
Stay informed on discovery and non-clinical formulation development, pharmaceutical development and manufacturing industry science, regulatory guidelines and competitive trends to provide informed recommendations.
Collaborate with discovery, early and late development partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Some international travel may be required.
Other duties as assigned.