Akston Biosciences Summary
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world's first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies in parallel to commercial launch of its Covid-19 vaccine. It owns and operates a GMP biologics manufacturing drug substance facility in addition to its research laboratory at its Beverly, Massachusetts location.
* Develop and validate analytical methods in support of COVID-19 vaccine development, Type-1 Diabetes therapeutic development, veterinary product development, and other projects as needed.
* Conduct in-process, release and stability testing, of pharmaceutical products in a GMP environment in support of COVID-19 vaccine development, Type-1 Diabetes therapeutic development, veterinary product development or other projects as needed
* Conduct GLP or clinical in vivo study sample analysis in support of tox studies and clinical trials
* Write analytical method and instrument SOPs for use within the Quality Control lab
* Confer with other scientists to review and analyze scientific data, interpret test results, and compile results into assay or technical reports.
* Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed; this includes routine cleaning and maintenance, calibration, and IQ/OQ/PQ of equipment.
Other Responsibilities & Skills
* Keep detailed records of data and appropriately document experimental procedures and results according to established guidelines
* Good organizational skills with ability to adapt to changing priorities, to multi-task in a fast-paced and dynamic environment and to meet challenging timelines
* Must be capable of working both independently and within a team environment
* Ability to help develop solutions to complex problems and establish processes to continuously improve and streamline existing procedures
* Strong communication and interpersonal skills.
* Assist in ordering of lab supplies.
A master's degree in Chemistry, Biology, Biomedical, Pharmaceutical Sciences or related field with 3+ years of work experience in analytical laboratories in the pharmaceutical or biotech industries required, or a PhD with 1+ years of pharmaceutical industry work experience; Quality Control Laboratory experience in support of GMP/GLP strongly preferred.
The successful candidate shall :
* Demonstrate a strong proficiency in developing, optimizing, and validating analytical assays in one or more of the following analytical areas, preferably in a cGMP or QC environment: ELISAs (e.g., potency, host cell protein, anti-drug-antibody, etc.), qRT-PCR, cell-based assays, or microbiological assays. Experience with other analytical methods (e.g., endotoxin testing, SDS-PAGE, etc.) a plus.
* Have the proven ability to troubleshoot and solve problems with assays both during development and routine work.
* Have extensive experience in several of the following areas: writing technical reports, validation reports and SOPs; conducting release and stability testing for pharmaceutical products; environmental monitoring; working in an aseptic environment (e.g., clean room or sterile hood); and performing analytical instrument IQ/OQ/PQ and calibration.
* Formal training and previous work experience in a cGMP or quality control laboratory highly desirable
* Demonstrate strong skills with common analytical programs (e.g., SoftMax Pro, Prism, etc.), Microsoft Word, Excel, and PowerPoint
Title and pay commensurate with skills and experience, eligibility for company benefit plans.
Must live within commuting distance of Beverly, MA.
Akston Biosciences leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including autoimmune disease therapies, ultra-long-acting insulins, and vaccines. Akston has built a diverse pipeline of therapeutic candidates for use in both human and animal health. Akston has an immediate opening for a Senior Associate or Scientist - Quality Control position for the company located in Beverly, MA. For more information, see www.akstonbio.com.
Candidates should send CV and cover letter to firstname.lastname@example.org or email@example.com