Senior Biopharmaceutical Development Specialist

7 days ago

Chennai, Tamil Nadu, India beBeeBiopharmaceutical Full time US$ 80,000 - US$ 1,50,000
Design Control Associate II - Biopharmaceutical Development

We are seeking a highly motivated and experienced professional to support the global Biotherapeutics PharmSci organization in India.

The successful candidate will provide expertise for design control projects for biologic modalities developed as combination products throughout the product and design control lifecycle.

This role will interact with cross-functional development teams working with all levels of employees and geographies to ensure deliverables from the team.

The qualified candidate will be a scientific professional with a basic understanding of biologics pharma product development, seeking to lead the industry in technologies applied to advance biotechnologically derived products to the market through innovation.

Job Responsibilities:
  • Function as a team member and be involved in cross-functional teams across many sites in the United States, Europe, and India.
  • Evaluate that combination product development activities are compliant with quality and regulatory standards – both internal and external.
  • Responsible for supporting the planning, coordination, execution, and communication of design control activities.
  • Individuals in this group will be the primary authors, reviewers, and approvers of design control documents such as design transfer checklists, risk management summary reports, including risk assessments, to support the device portfolio.
  • Support in Define, plan, and Lead design control and risk management activities for combination product development programs ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
  • Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
  • Support internal and external audits of the DPDD Quality System.
  • Evaluate resolution of issues and manages risks within project.
  • Investigate opportunities for novel approaches to resolve issues and problems.
  • Remain knowledgeable about current regulations and guidance.
Required Skills and Qualifications:
  • Bachelor's or Master's in Biotechnology, Biochemistry, Biomedical, Mechanical, Materials, Chemical Engineering, or other related discipline.
  • PREFERRED QUALIFICATIONS
  • Minimum 1-2 years of experience in Biopharmaceutical Industry Medical Device industry with interdisciplinary drug product or combo product development knowledge.
  • Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, and the EU Medical Devices Directive.
  • Working knowledge of EN 62366 HE75 and EU Medical Devices Regulation Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes injectors, luer connectors, and quality system regulations Part 4 for combination products.
  • Understanding of Design Controls for Combinations Products Device risk management expertise preferred Experience with biotechnology products and administration combination products such as prefilled syringes, pen injectors, and auto-injectors is a plus.
  • Sound interpersonal, collaborative, and consensus-building skills, including diplomacy to negotiate conflicting priorities.

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