Senior Biomedical Engineer

Director of Product Development & Manufacturing

Apogee Technology, Inc. is looking for a Director of Product Development & Manufacturing with 10-15 years of experience in the Biotechnology or Pharmaceutical Industry.

The successful candidate will take a leading role in the development of a drug/device combination product and will work directly with the Vice President of R&D in defining a product prototype and transitioning it into pre‑clinical and clinical stages. She or he will assemble a multifunctional team to provide required expertise for the drug/device integration effort.

Advanced degree in pharmaceutical science, polymer science, biomaterials, or related discipline is required. Working knowledge of manufacturing environment, process development and scale‑up, cGMP guidelines, QC/QA method development and validation is a must. Experience with formulation development, drug delivery, and controlled release systems, as well as general understanding of transdermal delivery applications are highly desirable. The ideal candidate will also have previous exposure to biomedical device manufacturing.

In addition to exciting technology and career growth opportunities, Apogee offers competitive wages with a benefit plan.

Apogee Technology, Inc. is looking for a talented, hands‑on biomedical engineer with 5+ years of medical device industry experience to take a lead role in the development of a novel drug delivery technology.

The successful candidate will function as a leader on various engineering development tasks and be responsible for creating strategies to evaluate the performance of a new medical device. Initial responsibilities include design, development and execution of test methods for validating the device performance. Working knowledge of FDA guidelines, design control, test method validation, and design verification is required in order to efficiently write protocols, perform laboratory or in‑vivo experiments, and review and analyze test results.

The candidate will prepare technical reports containing all specs, drawings, documents, equipment, material components and lead‑times, and work directly with the head of department in getting all functional areas involved to commit to a plan that addresses marketing requirements. The candidate will interact with other departments and functional areas to expedite projects and programs.

Advanced degree in an Engineering discipline is highly desirable. Demonstrated knowledge of silicon, plastic and/or metal component design for medical products is required. Must be able to communicate appropriately and accurately both orally and in writing the progress of assignments and product development efforts.

Additional requirements:

project management experience with proven ability to complete projects on a timely basis, team player, ability to participate on multifunctional development teams, independent thinker and problem‑solver, experience in process development such as characterization, scale‑up, equipment selection, operating mechanical testing equipment and collecting and analyzing in‑vitro and in‑vivo data.

In addition to exciting technology and career growth opportunities, Apogee offers competitive wages with a benefit plan.

The purpose of the Formulation/Research Scientist is to support formulation development by studying project objectives and requirements; conducting bioanalytical research; operating analytical instruments; preparing reports; adhering to guidelines and regulations.

The successful candidate will perform the following duties:

• Develops HPLC methods for the analysis of small molecules and polymers; prepares and analyses formulation samples.
• Maintains procedure integrity by adhering to standard operating procedures (SOPs), good laboratory practices (GLP), and current good manufacturing practices (cGMP).
• Prepares reports of laboratory results by collecting, analyzing, and summarizing bioanalytical data and trends.
• Maintains safe and healthy lab environment by following organization standards and legal regulations.
• Maintains supplies inventory by checking stock; anticipating needs; placing…