Senior Scientist, Analytical Development/Quality Control
Position Title: Senior Scientist, Analytical Development/Quality Control
Location: Groton, CT
Summary: 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.
The HBV pipeline consists of a lead program in multiple global Phase 2a studies; a 2nd Generation program entering Phase I late this year, and a 3rd program approaching clinical candidate selection. We expect this pipeline to represent a backbone therapy for increasing cures in HBV, and can be envisioned as a foundation of the company’s research in virology globally.
The Microbiome platform consists of our lead programs in GI, partnered with Allergan, nearing the first IND/Phase Ib later this year and early next for Ulcerative Colitis, and a pipeline of other disease areas in consideration for advancement that are wholly owned by ASMB.
The Company has a strong balance sheet having recently raised $166 million, bringing its cash reserves to approximately $250 million – and 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.
The selected candidate will be tasked with leading the establishment of robust analytical methodologies and providing bench-side analytical direction, including performing hands-on laboratory work in support of process development, characterization activities, specification, and stability testing. Working closely with Process Development teams, the candidate will coordinate and execute testing activities, as well as authoring technical protocols and reports, as applicable.
Technical expertise in flow cytometry is a critical requirement for this role, as are experience in hands-on method development activities, execution and troubleshooting of existing methods. Experience within the GMP QC environment would be favorable.
In addition to flow cytometry, specific proficiency with qPCR, microbiological methods (cell growth, etc.), Karl Fischer, and dissolution/disintegration is highly desired; experience with other general techniques such as microscopy and spectrophotometric methods is beneficial.
Knowledge of good documentation practices and an attention to detail are also expected of the incumbent. Additionally, the successful candidate will be expected to function independently with minimal supervision and preferably serve as technical lead for other staff. Experience with regulatory filings would be advantageous for participation in IND/BLA preparation.
- Participate in directing and executing operations for in-house analytical development and testing capabilities
- Participate on cross-functional teams relating to process development
- Develop robust and reproducible analytical methodologies for evaluation of product quality attributes and characterization studies
- Support OOS, root cause, and CAPA investigations, including execution of troubleshooting activities, as necessary
- Execute analytical testing and author technical documents
- Participate in the preparation of regulatory filings
- Motivated self-starter who can work independently with minimal supervision; provide technical leadership to other staff
- Excellent professional and interpersonal skills
- Excellent oral and written communication skills
- Ability to work efficiently and cooperatively in a virtual company environment
- Goal oriented and ability to deliver on timelines and commitments
- Exhibits a proactive, transparent, and rigorously objective confidence in all aspects of analytical development/quality control activities
- Education in Microbiology, Chemistry or a related discipline, experience in Biotech/Pharma industry with hands-on background and directly relevant experience with microbiological/biologic testing. Position level and compensation will depend on education and relevant experience
- Technical expertise with flow cytometry
- Specific experience with anaerobic cultures is highly desirable
- Hands-on experience with applicable analytical instrumentation, including the ability to set-up, operate, and troubleshoot equipment
- Demonstrated ability to independently write technical documents
- Knowledge of cGMPs
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.