Skills & Responsibilities

• Support the commercial and operational organization through the quality of decisions, results, and ensure product quality standards and supply are met within budget and quality release specifications

• Understand cGMP processes and regulations as outlined in 21 CFR parts 111 and 211, and design and implement new manufacturing processes compliant with these standards. Preferably 21 CFR Part 211 experience with proven ability to apply regulations.

• Responsible for leading and directing all aspects of the multi-product manufacturing operation, including upstream, downstream, and technical services

• Utilize knowledge to design and implement novel and scalable manufacturing processes within the scope of the organization’s product portfolio

• Support and execute startup and validation of new manufacturing equipment and processing equipment to ensure requirements and specifications per quality standards

• Work with quality to support FDA and State inspections and audits by providing technical support and assessment in response to internal audit programs and external regulatory agencies

• Oversee and perform production-related investigations and out of specification matters with internal and external regulatory departments

• Draft and complete manufacturing batch records for new and existing processes; collaborating with subject matter experts will be required

• Work with Finance and Supply Chain to prepare and manage department budget and workforce models

• Work in partnership with the Quality Assurance Division to ensure cGMP is maintained and documented

• Work in partnership with R&D and method development teams to ensure successful tech transfer and implementation of novel processes

• Work with the management team on planning, organizing, and directing manufacturing operations and ensuring compliance with all local, state, and federal regulation

• Make observations in manufacturing to judge the effectiveness of operation, utilization of personnel and supplies, and general ethical and professional atmosphere 

• Maintain the facilities, equipment, and supplies which are required to carry out effective manufacturing and create an optimized environment

• Prepare manufacturing budgets for personnel, operating expenses, capital equipment, and external projects

• Serves as a member of a high performing technical team that is cross-functionally integrated with colleagues across product development, analytical testing, and manufacturing

• Draft standard operating procedures (SOPs) for equipment and manufacturing processes, report summaries of work performed, and prepare presentations

Requirements

• An advanced degree (Ph.D. or MS) in a scientifically related field (e.g., biology, chemistry, biochemistry, pharmaceutical sciences, etc.) with 10+ years of industry experience in a regulated environment

• Doctorate Degree – 5 years of Manufacturing/Operations Experience

• Master Degree – 8 years of Manufacturing/Operations Experience

• Bachelor Degree – 10 years of Manufacturing/Operations Experience

• Significant experience with nanotechnologies such as liposomes, lipid-based nanoparticles, micelles, emulsions, and polymeric particles; and related manufacturing equipment such as high shear mixers and high-pressure homogenization a must 

• In-depth, diverse, and hands-on operations experience in a technical manufacturing operation leadership discipline in the dietary supplement, food; Pharmaceutical experience preferred

• Managerial experience and track record of compliance in regulated GMP environments; minimum of 3 years of managerial experience directly managing people and leadership experience leading teams, allocating resources, and projects

• Working knowledge of Microsoft Productivity Software (Word, Excel, PowerPoint, etc.), Google Suite, Dropbox, Slack, Zoom, Salesforce

  Benefits

• Comprehensive package