Associate Director/Director, CMC, Analytical Development

We are seeking an Associate Director/ Director, CMC, Analytical Development to join our CMC team. The incumbent will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He/she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (including GLP and cGMP). He/she will provide analytical support for drug substance and drug product manufacturing in support of preclinical, clinical, registrational, validation, and commercial batches.

This position reports to the Executive Director, CMC, Analytical Development and will be located in Boston, MA, USA. We may consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Relocation and immigration support will be provided, if required.

RESPONSIBILITIES:

• Work with cross-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard qualification, and product characterization.
• Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products, both internally and across Xenon’s network of CDMOs.
• Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing.
• Manage analytical activities at CROs/CDMOs including method development and qualification/validation, method transfer, and characterization testing. Conduct the review of analytical raw data packages. Ensure that studies are conducted in compliance with GLP and cGMP regulations, as applicable.
• Resolve technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external Quality Control, Quality Assurance, and Regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
• Collaborate closely with Quality Control and Quality Assurance to ensure the timely GMP release of drug substance and drug product lots.
• Author/review technical documents outlining analytical activities including method validation, method transfer, reference standard and impurity characterization, stability, etc.
• Author/review analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
• Represent the analytical function in CMC teams and interdepartmental meetings
• Maintain current knowledge of issues relevant to drug development, Competent Authority regulations and guidance, as well as industry trends.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Act in accordance with Company policies.
• Ability to travel up to 25% domestically and internationally.
• Other duties as assigned.

QUALIFICATIONS:

• Ph.D. or M. Sc. in analytical chemistry or a closely-related field with 10+ years of directly-related industry experience.
• Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3)
• Extensive analytical method development, troubleshooting, and validation experience
• In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), the identification of impurities and degradation products, and reference standard qualification.
• Demonstrated knowledge of drug development, CDMO management, manufacturing, and regulatory CMC. Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to the testing of both drug substances and drug products in both development and commercial contexts.
• Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
• Experience preparing and updating regulatory filings (IND, IMPD, CTA, NDA, MAA)
• Ability to effectively organize and prioritize tasks to achieve established deadlines
• Ability to multi-task and adapt rapidly to changing business requirements in a dynamic corporate environment
• Proven problem-solving skills are a must.
• Experience managing projects and FTEs at GMP testing CROs.
• Excellent oral and written communication, leadership and interpersonal skills as well as the ability to build trust and credibility inside and outside the Company.
  
  

The base salary range for this role is $172,000 to $229,300 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.