Manufacturing and Production
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Job: CMC Leader, Milestone Pharmaceuticals, Charlotte, NC
Charlotte, NC 28277 United States
1111 Dr. Frederik-Philips
Manufacturing and Production
The Chemistry Manufacturing and Controls (CMC) Leader may be a Director/Senior Director or VP level position depending on experience, and reports to the CEO. The CMC Leader is responsible for independently creating and implementing CMC and Pharmaceutical development strategies, and will have a leadership role in providing direction for the progress of team projects as the company’s subject matter expert (SME) with regulatory agencies and external contract manufacturing organizations. This position may be located in Montreal, Canada or Charlotte, NC.
• Leads all areas and activities related to the clinical and commercial supply for etripamil, Milestone’s lead drug candidate, as well as any future development program;
• Oversees chemical synthesis of API as well as formulation development and production for the drug product and filling and labeling of final finished form to achieve corporate filing goals of IND/NDA dossiers;
• Provides technical and administrative leadership to the external CMOs;
• Independently creates and implements strategies to solve complex problems in the areas of formulation development, including pre-formulation, process development, process optimization, scale-up and clinical manufacturing, and clinical packaging;
• Acts as area manager for SOPs, change controls, deviations and CAPAs;
• Oversees preparation of master batch records and other documentation supporting or constituting Common Technical Document (CTD) modules/sections for all NDA/IND submissions;
• Partners with Regulatory to coordinate contract research organizations during clinical studies;
• Conducts briefings and technical meetings for top management and board of directors, and provides regular updates on goals and progress pertaining to company projects;
• Represents CMC and acts as SME with government agencies, e.g., FDA/EMA, during meetings or in responding to deficiencies to submitted IND/NDA/IMPD applications;
• In areas of clinical supply, functions as key scientific liaison between the Quality, Project Management, and Clinical departments;
• As part of a lean internal core team, builds and manages the extended team comprised largely of partners (consultants/vendors);
• With Business Development and Project management departments, interfaces with key stakeholders that are both internal and external to the company;
• Facilitates open channels of communications across departments to align business strategies.
• Participates in networking opportunities to establish and benchmark best practices in scientific affairs;
• Develops and is accountable for components of the Product Development budget, and manages budget by identifying cost reduction or savings opportunities.
Education and Work Environment:
• Advanced degree preferred (M.S. or Ph.D.) in Pharmaceutical Sciences, Chemistry or equivalent;
• Fifteen (15) plus years of pharmaceutical industry experience in formulation development, process development and/or manufacturing;
• Experience as a CMC project leader for late-stage development projects;
• NDA filing and approval experience;
• Able to travel as needed, within the U.S. and overseas;
• Able to participate in CMO vendor audits as required, within the U.S. and abroad; and
• Experience working virtually is strongly preferred.
Technical Knowledge and Skills:
• Understanding of pharmaceutical dosage form development and manufacturing technologies;
• Understanding of current Good Manufacturing Practices;
• Current working knowledge of FDA regulatory guidance, ICH guidelines and requirements of NDA and INDs;
• Current working knowledge of EU regulatory guidance such as CTAs and IMPDs, as well as QP release procedures;
• Proficiency in patents, pharmacokinetics and biopharmaceutics; and
• Proficiency with Microsoft Office software.
Non-Technical Skills and Competencies:
• Outstanding verbal and written communication skills;
• Superior problem solving, conflict management and interpersonal skills;
• Exceptional organizational skills with the ability to multi-task and prioritize assignments;
• Ability to teach and lead others;
• Ability and willingness to work in a cross-functional team environment;
• Self-motivated with the ability to work independently with minimal supervision; and
• Ability to work under pressure to meet deadlines.
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