Location: San Diego, CA
Name: Alere, Inc.
Work can be done in San Diego, CA or Scarborough, ME
The Active Cconsumables Transfer (ACT) Chemistry Specialist manages a wide variety of technical tasks and projects in the development of new products and manufacturing processes. The Chemistry Specialist will consult on the robustness of reagent formulations and qualification of raw materials as well as in-process reagents. Further, the Specialist will assist the Product Development team to secure high-quality materials through material specifications with the aids of advanced analytical chemistry characterizations. In addition, the specialist will actively participate in selecting and qualifying material suppliers with the aim of achieving predictable product performance and cost containment. This individual will be a leader within the ACT team and a key member of Alere medical device product development teams.
- Responsible for the design, implementation and sustainability of manufacturing processes at Alere sites worldwide, with a focus on ensuring proper manufacturability is built into product and process designs
- Actively participates cross-functional team from plastic, chemistry, formulating and processing groups for transferring new products from R&D to manufacturing group
- Leads formulation and plans for new products and process improvements at the feasibility stage to guide subsequent development and transfer planning
- Reports status of projects to Senior Director of ACT, project Directors and project stakeholders by using established project management methods; escalating issues which cannot be resolved by the team
- Provides facilitation and technical leadership in the generation of project technical content, including specifications, studies, and reports
- Provides technical expertise on biological substances, chemical reagents, plastics, adhesives and process equipment
- Provides subject matter expertise in the design, development, and validation of formulations, processes, and analytical test methods
- Ensures documentation is complete and meets defined requirements
- Possesses a working application/knowledge of medical device regulatory requirements and standards.
- Identifies opportunities for process improvements and cost savings
Advanced degree in organic, inorganic or polymer chemistry preferred
- Minimum of 10 years' experience in product development and support of medical devices
- Excellent conceptual, analytical, and problem-solving ability.
- Experience in design of experiments (DOE).
- Good communication skills, both verbal and written, and the ability to effectively interface with a cross-functional team environment.
- Experience in modern manufacturing principles and techniques.
- Experience in surface characterization of plastics and structural characterization of inorganic, organic and biological substances.
- Ability to influence project owners and line workers with persuasive and yet comprehensible technical information.
- Experience in material sciences, such as surface activation/relaxation of plastics.
- Must have the ability to work cross-functionally with teams.
- Knowledge of and compliance with applicable Quality System requirements (e.g., FDA, ISO & MDD) and experience working in a regulated environment is preferred.
- Good presentation skills to deliver updates and/or presentations effectively to a variety of audiences are required.
- This position may require up to 30% domestic and international travel.
- Experience in managing or interfacing with analytical chemistry group is preferred.
- Industrial experience in recommending and evaluating analytical methods for cGMP applications
- Understanding of chemical interferences stemming from substrates, adhesives, plastics, metabolites to clinical samples is preferred
- Solid knowledge of protocol and assessment of US and world patents relevant to medical device applications is preferred
- Working experience in and collaboration with clinical trials are preferred
- Ability to provide concise technical landscape of the project and recommend expeditious pathway for completing the technical transfer from R&D to operations is preferred
- Ability to translate complex technical jargons into comprehensible ideas to all team members is preferred
- Experience in characterizing, stabilizing and kinetics of non-catalytic, like antibodies, and catalytic proteins, like enzymes, is preferred
- Industrial knowledge of clinical chemistry is preferred
- Industrial knowledge of reagent applications on plastic and bibulous substances is preferred
- Experience in designing and fabricating electrochemical biosensors is preferred