Associate Scientist, Drug Substance Process Development
Position Title: Associate Scientist, Drug Substance Process Development
Reports to: Senior Director, Process Development
Status: Regular, Full-time, Exempt
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 for Drug Substance Process Development will play a pivotal role in the development of processes for the production of human commensal bacteria suitable for formulation as Drug Product. It is expected that the individual will also work closely with the Drug Product formulations team to coordinate the transfer of formulations and processes, facilitate phase-appropriate scale-up, provide analytical support and lead troubleshooting activities.
Specific responsibilities include, but are not limited to:
- Evaluate, and qualify new technologies related to fermentation, harvest, and lyophilization
- Contribute to studies and/or activities necessary for process optimization and continuous improvement to assure robust and cost-effective manufacturing processes
- Assure consistent and reproducible manufacturing processes and final drug substances
- Manage and execute troubleshooting activities, as necessary
- Transfer manufacturing operations to alternate sites, as appropriate, to assure continuity of supply
- Support the Drug Product Process Development group with material supply and some analytical support
- Write technical reports
- Build and maintain a strong cooperative working relationship with colleagues in Drug Product, Analytical, Quality, Regulatory, Clinical Development, Project Management, and Legal
- Must have ability to travel on a limited basis (10%)
- BS/MS with 1-5 years’ experience in Biotech/Pharma industry with hands-on background and experience with fermentation and/or lyophilization
- Specific experience with bio-processing and/or fermentation (anaerobic culture experience is highly desirable)
- Hands-on experience with pharmaceutical processing equipment, including the ability to set-up, operate, and troubleshoot equipment (fermentors, filtration, lyophilizer, etc.)
- Demonstrated ability to independently write technical reports
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.