Drug Development Jobs in Alabama (NOW HIRING)

Responsibilities
Include but are not limited to the following: 
   Define, create and communicate a commercialization path for new medical devices or pharmaceutical product solutions from concept creation through product development.
   Create documentation to define system requirements and specifications, managing internal and external stakeholders, through development, validation, documentation and release of products.
   Leads cross-functional project execution for platform technologies, ensuring compliance with ISO 9001 and ISO 13485 standards
   Act as a customer-facing representative for platform technologies, including participation in industry trade shows and technical discussions
   Collaborate with internal stakeholders including R&D, Regulatory, and site teams to ensure successful delivery of services related to pre-clinical to Phase II within oral solid dose drug development
   Assist in North America product sustainability as a technical lead, coordinating Operations, R&D, and Regulatory Teams for product recyclability initiatives to align with regulatory critical guidance
   Work with a multi-disciplinary product development team and cross business unit to develop, evaluate, document, and introduce new products.
   Review all designs and validations to ensure all specifications are being met
   Conduct appropriate project risk assessments and define a mitigation plan
   Develop approaches to sustain and communicate success and progress across global stakeholders
   Support sales efforts in the bid process to gain repeat, and/or new, long-term business as needed.
   Partners with Industrial Designers to incorporate sponsor user requirement specifications to create innovative solutions
   Work with intellectual property counsel to submit IP invention disclosure and ensure all data and drawings are provided for provisional applications
   Participate in monthly Project Phase Reviews and provide updates to assigned projects along with status update on current phase
   Runs concurrent projects effectively
   Other duties as assigned

Qualifications/Education/Special Skills
Education
   BS Degree in Engineering field (Chemical, Electrical, Mechanical, Biomedical, or related field) required.
   PMP (Project Management Professional) certification strongly preferred.
Experience
   5-7 years of leading product development and project/program management experience within the Medical Device or Pharmaceutical industry
   Proven experience managing cross-functional teams and customer-facing projects.
   Experience with IND, NDA, NDA 505(b)2, and ANDA drug development preferred
   Familiarity with ISO 9001 and ISO 13485 quality management systems and regulatory standards.
   Experience with design verification, validation, and documentation processes.
   Demonstrated success in mentoring and performance management of direct reports
Technical Skills
   Strong working knowledge of design controls and regulatory requirements (US, EU, Japan, China).
   Proficiency in ICH-GCP/ISO 14155 and clinical research regulatory frameworks.
   Skilled in documentation, testing, and design-control procedures.
   Proficiency in statistical and analytical tools, including design of experiments (DOE).
   Broad knowledge of polymeric materials and processing techniques (extrusion, injection molding, thermoforming) preferred.
   Familiarity with sustainability and recyclability initiatives in product development.

Soft Skills & Tools
   Excellent written and verbal communication skills; able to present to stakeholders at all levels.
   Strong organizational and time management skills; capable of managing concurrent projects.
   Ability to work independently and collaboratively in a virtual or cross-site environment.
   Proficiency in Microsoft Office Suite (Project, Excel, Word, PowerPoint).
   Ability to interface effectively with Sales, R&D, Regulatory, and Operations teams.