Director, CMC (onsite in Chicago, IL)

Role Summary

The Director, CMC provides leadership for the Chemistry, Manufacturing and Controls (CMC) function for Xeris’ commercial and clinical/late-stage development products. This role provides subject matter expertise for all aspects of Drug Substance (API), Drug Product, and Combination/Device product development against the applicable regulations and standards in preparation for post-approval changes and submission of Regulatory Market Approvals by USFDA and other Health Authorities. This expertise translates into skillful and competent application of knowledge to ensure the CMC function is in alignment with the Company’s corporate and departmental goals.

Responsibilities

• Chemistry, Manufacturing, and Controls lead for Xeris‚Äô commercial and clinical/late-stage products and projects.
• Leads CMC Regulatory Submission support for US FDA and other Health Authorities.
• Ensures all Quality by Design (QbD) and Design Control activities related to drug substance, drug product, and combination/device products are completed in accordance with current GMP, quality principles, and regulatory expectations to support relevant global regulatory submissions.
• Authors, reviews and edits CMC sections and provides input into Regulatory submissions and regulatory approvals (e.g., IND, CTD, NDA, and MAA). As necessary, will train other departmental staff in the preparation of CMC sections and responses to Health Authority questions.
• Supports the preparation and management of complex CMC development plans including long-range planning.
• Collaborates with other areas of the PDTO department (e.g., Formulation, Analytical, and Device Development, Manufacturing Sciences & Technology, Commercial Manufacturing, Supply Chain Logistics) to ensure products are manufactured to phase-appropriate standards and scale in support of company clinical trials.
• Collaborates with other external functions on CMC matters (e.g., Quality, Commercial, Regulatory Affairs, etc.). Ensures the CMC function is adequately represented on Project Teams.
• Provides input on strategic guidance for corporate development plans, including project cost estimates and budgetary planning.
• Establishes, directs, and allocates the necessary headcount and financial resources within the CMC function needed to support the company‚Äôs business strategy.
• Provides CMC support for Information Requests during the submission review process.
• Provides scientific/technical guidance and oversight while factoring in manufacturability, regulatory, and compliance considerations via risk-based approaches.
• Continually monitors the evolving global regulatory landscape regarding CMC aspects of regulatory practices and determines potential impact to Xeris‚Äô products.
• Supports PDTO team members in management of Contract Manufacturing Organizations (CMOs), contractors, consultants, suppliers, and all outsourced CMC activities.
• Ensures the selection of appropriate vendors and oversees their subsequent technical management to ensure competence and data integrity through all stages of development.
• Reviews MSA/Technical/Quality agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercising appropriate oversight of the activities.
• Ensures the professional development of CMC team members through deployment of a proactive talent management strategy, active coaching, and mentoring.

Qualifications

• Master‚Äôs Degree in pharmaceutical sciences, engineering, or related scientific discipline and a minimum of 12+ years of broad CMC-related experience in the pharmaceutical industry.
• Managerial experience with a team of CMC professionals, leading cross-functional projects, planning and delivering results within project deadlines.
• Successful submission, review and approval of CMC sections of regulatory submissions.
• Experience with complex CMC regulatory submissions for both development and marketed products; analytics expertise and knowledge of drug/device combination and medical device regulatory pathways.
• Quality by Design experience including development of CQAs, CMAs, and CPPs using risk assessment tools (e.g., FMEA, FMECA).
• Manufacturing process validation expertise, including lifecycle management and post-approval changes.
• Understanding of US, EU, and ICH regulations and requirements.
• Experience with a wide range of product types (small molecules and biologics), dosage forms and manufacturing technologies including aseptic processing.
• Ability to build effective relationships across internal and external organizations, including in a matrix environment.
• Competencies: Leadership, teamwork, attention to detail, self-starter, analytical skills, problem solving, organizational skills, project management, adaptability, professionalism, written and verbal communications, presentation skills.
• Working Conditions: periodic evening/weekend work and occasional overnight travel; on-site at the Chicago office at least three days per week; on-site requirements may change.

Education

• Master‚Äôs Degree in pharmaceutical sciences, engineering, or related scientific discipline.

Additional Requirements

• None additional beyond the above.