Materials Coordinator, Quality Control

Location
Groton, CT, United States
Posted
Jan 09, 2019
Ref
143
Required Education
Bachelors Degree
Position Type
Full time
Position Title: Materials Coordinator, Quality Control

Reports to: Manager, Quality Control

Status: Regular, Full Time

Location: Groton, CT

About Assembly: Assembly Biosciences (NASDAQ symbol ASMB) is a clinical-stage biotechnology company advancing two innovative platform programs: a Hepatitis B-Cure program consisting of a new class of oral therapeutic candidates for the treatment of hepatitis B virus (HBV) infection and a novel class of oral synthetic live biotherapeutic candidates, which are designed to treat disorders associated with the Microbiome. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team great people who are driven to transform the lives of patients.

We believe our Microbiome platform represents the best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in ulcerative colitis, is currently in IND enabling studies and is expected to enter the clinic in 2019. This program is part of a broader partnership we established with Allergan in 2017 for GI programs with a potential total development and commercial milestones of up to $2.8 billion. Our internal pipeline will represent first in class or best in class microbiome approaches in areas such as immuno-oncology, liver diseases, and other areas of high medical need.

Assembly is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and a research office in Shanghai, China. Assembly has a strong balance sheet having raised approximately $166 million in July 2018, thus positioned well to build the next phase of Assembly toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.

Summary: The Materials Coordinator supports the Quality Control Department with coordination and maintenance of Quality Control systems and documentation to advance Assembly Bioscience's microbiome platform.

The successful candidate will coordinate the execution of several systems including stability, raw material, and sample management. This will require collaboration with all Assembly departments as well as adhering to appropriate regulations and compliance expectations. This individual will also be tasked with compilation of data into technical reports and the authorship of certain technical documents, such as Certificate of Analysis. Additionally, the performance of analytical testing for the aforementioned programs will be required for basic laboratory methods, on an as-needed basis. The selected candidate will be responsible for coordinating shipments of samples to contract testing laboratories as needed.

Specific responsibilities include, but are not limited to:
  • Ownership of the sample management process for Analytical Development and Quality Control
  • Execute receipt of incoming cell banks, drug substances, and/or drug products from CMOs
  • Input and management of applicable procedures and materials
  • Assist with management of the Stability Program including aliquoting materials, stability pulls, and compiling results into reports
  • Preparation, circulation, and tracking of Quality Control documents, including, but not limited to test records, certificates of analysis, specifications, protocols, technical reports, procedures, logbooks
  • Shipping materials between CMOs, CTLs, and Assembly facilities
  • Alert system response for controlled temperature unit/stability chamber monitoring and timely response to associated excursions
  • Author minor deviations, CAPAs, and laboratory investigations
  • Coordinate the QC raw material program including receipt of materials, testing, release of materials, retain sampling, and associated documentation
  • Perform monthly cleaning and routine laboratory testing including, but not limited to, appearance, FTIR, endotoxin, content uniformity, and other basic laboratory methods

Qualifications include:
  • Bachelor's degree in scientific or healthcare discipline and 2 - 5 years of relevant industry experience. Alternative combinations of education and experience will be considered. Position level and compensation will depend on education and experience
  • At least 1 year of experience working in a cGMP environment with knowledge of regulatory expectations
  • Familiarity with anaerobic cultures, aseptic technique, microbial testing (environmental monitoring, bioburden), and compendial raw material testing (endotoxin, gas chromatography, FTIR, titrations, etc.) is highly desirable
  • Experience with technical writing, laboratory investigations, and deviations is a plus
  • Strong communication skills
  • Excellent organizational and time management skills with high attention to detail
  • Motivated and quick learner able to swiftly change priorities in a fast-paced environment
  • Superb interpersonal skills and ability to work proactively and cooperatively with other departments within Assembly Biosciences

Travel:
  • Travel is not anticipated


AAP/EEO Statement
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.