Associate Director, CMC, Drug Substance

Xenon Pharmaceuticals•Needham, MA

5d•$172,300 - $217,900•Hybrid

About The Position

We are seeking an Associate Director, CMC, Drug Substance to join our CMC Drug Substance team. The candidate will help manage and oversee the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for deployment in pre-pivotal and pivotal clinical trials. The Associate Director will be a key member of a highly collaborative internal CMC team, primarily managing API development programs and manufacturing campaigns through contract development and manufacturing organizations (CDMOs). This position reports to the Senior Director, CMC, Drug Substance, and will be based out of Boston, MA, USA. We will consider remote locations for exceptional candidates.

Requirements

PhD in Chemistry or other relevant discipline with a minimum of 10 years of directly related experience in a pharma or biotech environment. Candidates with a MSc and significant relevant experience may be considered as well.
Demonstrated track record in successfully managing development-stage and/or commercial-stage API manufacturing activities conducted at CDMOs. Strong emphasis will be placed on experience in running initial cGMP deliveries followed by tech transfers to later stage development CDMOs.
Experience authoring/co-authoring key CMC sections in U.S. IND/NDA and European MAA filings for small molecule APIs
Extensive knowledge of cGMP-related regulations, guidance documents, principles, and best practices pertinent to APIs
Strong experience in working within a virtual manufacturing setting that requires knowledge of CDMO landscape and selection, vendor management, contracting, issue resolution and management
Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel and experience in applying risk-based decision-making tools.
Excellent oral and written communication and interpersonal skills as well as the ability to build credibility and trust inside and outside the Company
Excellent attention to detail and commitment to providing accurate, high-quality work.
Good organizational skills and the ability to manage multiple competing priorities.
Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.
Be science- and data-driven while at the same time, creative and flexible in strategic thinking and problem solving
Ability and willingness to travel up to 15% of the time, both domestically and internationally

Responsibilities

Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards
Evaluate, recommend and manage qualified CDMOs for the manufacture of API for clinical trials, as well as for commercial use
Collaborating closely with the internal process chemistry team, manage API process technology transfer to the Company’s CDMOs, including process development and the establishment of suitable specifications for APIs
Work closely with Supply Chain and CMC Drug Product colleagues to translate clinical demand forecasts into API manufacturing plans
Author (in conjunction with Technical Writing) and/or act as a key reviewer of core CMC documents/modules and other forms of submissions and responses to FDA and other Competent Authorities providing strategic oversight and consistency for regulatory interactions, including, but not limited to, IND/NDA/MAA/IMPD filings and periodic updates thereto
Participate and manage API-related budget proposals and approved project budgets in accordance with the Company’s strategic and operating plans and Finance policies
Serving as the subject matter expert, participate in audits and inspections of API CDMOs in conjunction with Quality Assurance
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and Intellectual Property policies. Ensure that policies are understood and followed by direct reports.
Some international travel may be required
Other duties as assigned