Associate Director, Commercial Manufacturing

Overview

The Associate Director, Commercial Manufacturing will lead manufacturing activities for Xeris’ commercial products as a subject matter expert (SME) and provide strategic and tactical support within the Product Development/Technical Operations (PDTO) department related to drug substances (API) and drug products.  This position will provide technical expertise and lead external operations at multiple Contract Manufacturing Organizations (CMOs) across the globe in alignment with Xeris’ corporate and functional area goals.  This position will proactively collaborate with other PDTO functional areas and external departments regarding relevant cross-functional activities on a routine basis, e.g., Product Development, Supply Chain, Logistics, Packaging, Device, CMC, Quality Control, Quality Assurance, Regulatory, and Finance.  This position will also collaborate on regulatory filings such as INDs, IMPDs, NDAs, MAAs, and the protection of the company’s intellectual property and maintain awareness of current industry trends and practices.

Responsibilities

Responsibilities include, but may not be limited to:

• Evaluate/select appropriate contract vendors and suppliers; negotiate contract terms; establish and maintain relationships and monitor performance with a focus on continuous improvement.
• Lead critical activities to ensure continuity of supply of the company’s commercial products and to maintain strong relationships with our network of external manufacturing partners.
• Provide expertise in the areas of technology transfer and manufacturing process validation.
• Responsible for a wide range of activities such as project management associated with the execution of drug substance and drug product manufacturing.
• Drive multiple projects at different manufacturing CMOs, including global long-term sourcing and life-cycle management activities.
• Provide technical review and approval of Engineering and GMP batch records, draft and executed process qualification protocols and reports, work instructions, SOPs, CMO change documentation, or other required documents for cGMP operations.
• Assist with the cross-functional operations within the PDTO department such as production planning, scheduling, and inventory management.
• Establish and meet team objectives for all assigned projects and create / maintain project timelines both internally and externally (CMOs).
• Lead any routine and nonroutine cGMP activities, key issues, deviations, investigations, CAPAs, process optimization, change control technical assessment, etc.
• Ensure business objectives/milestones are achieved while meeting quality/compliance standards.
• Ability to effectively manage multiple corporate priorities and have sound organizational/time management skills, and effectively communicate/present updates to executive team on a regular basis.
• Provide CMC knowledge and technical support regarding the company’s due diligence and regulatory submission documents. Leverage technical skills (chemistry/engineering, GMP regulations, risk evaluations, drug development), business skills (project management, finance), and soft skills (vendor engagement, relationship building) to provide strategic input for program core teams and budgets.

Qualifications

• This position requires an advanced degree in Pharmaceutical Sciences, Pharmaceutical Engineering, Chemical Engineering, Operations Management, or a related field.
• Requires at least 8 years’ experience in the pharmaceutical or biotechnology industry with 5+ years’ demonstrated leadership in the multi-disciplinary areas of CMC development (drug substance, drug product, analytical, packaging, device) and manufacturing/supply chain.  Some experience with specialty pharmaceuticals, medical device combination products, and orphan drugs for rare diseases would be a plus for this role.
• Must have a broad base of experience with a wide range of product types (eg, small molecules, biologics, synthetic peptides, oligonucleotides, therapeutic proteins, etc.) and a wide range of dosage forms (eg, oral, parenteral, immediate release, modified release, etc.).
• Direct experience with aseptic filling of small volume parenteral products and with vials, prefilled syringes, cartridges, and combination products.
• An in-depth knowledge of all stages of the drug development process is considered essential.
• Demonstrated strong working knowledge of supply chain management for commercial products is considered essential.  Experience with products for global markets is required.
• Knowledge of GMP regulations and industry practices for process validation, continuous improvement programs, and post-approval changes is required.
• Requires strong technical knowledge of process optimization, scale-up and technology tran