Job Description:
Duration: 6 months+
The Scientist IV participates in new diagnostic product delivery from design verification through commercial launch. The candidate will partner with both internal and external manufacturing organizations from selection of the organization through process transfer. The candidate is expected to participate in a cross functional team consisting of representatives from Research and Development, Operations, Quality Assurance, and Regulatory Affairs.
General Duties & Responsibilities:
• Participate in the selection of external manufacturers and complete process transfer with preparation of request for quote and statement of work.
• Suggests improvements to methodologies, processes, products, and systems related to particular projects.
• Prepare formulation records, testing records, SOPs and risk management plans as necessary.
• Prepares protocols and reports, including quantitative analysis where necessary.
• Tests, analyses, and interprets data and events requiring evaluation in response to product support requests and manufacturing non-conformances.
• Maintains lab equipment and follows lab quality and safety requirements.
• Maintain aggressive timelines for completion of projects. Capable of multitasking.
• Works well cross-functionally and as a team member.
• Must work by strictly adhering to internal standard operating procedures and policies.
• Must work by strictly adhering to the regulations and guidelines of all applicable regulatory agencies, such as FDA (QSR/cGMP), OSHA, ISO (including ISO14001), J&J and OCD Health, Safety & Industrial Hygiene.