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 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 a 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 talented, hands-on, biomedical engineer with 5+ years 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. 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. 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 and expediting orders; verifying receipt.

Updates job knowledge by tracking emerging trends in bioanalytical methods development; participating in educational opportunities; reading professional journals; establishing personal networks.

Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

Skills/Qualifications

BS in Chemistry or a related discipline plus 2-5 years of additional experience or MS plus 2 years of additional experience. Background in polymer or protein science with hands-on experience with routine analytical methods, such as HPLC and UV-Vis spectroscopy. Must have technical knowledge of protein and polymer separation techniques. Familiarity with GLP/GMP environment is a plus. Must possess a high level of initiative and the ability to work with little supervision.