Scientist I / II – Drug Substance Process Development (Microbiome)
Location: Groton, Connecticut
The Scientist I / II, Drug Substance Process Development (Microbiome) will serve as a critical resource in the development and qualification of robust processes for production of human commensal bacteria suitable for use as therapeutic agents. The individual will lead in the design and execution of complex experiments and perform data analysis relating to cell banking, fermentation, harvest, and freeze-drying processes. Execution of analytical testing to support rapid data generation would be highly desirable.
It is expected that the individual will work closely with Research, Drug Product Development, Manufacturing, Analytical Development, Quality Control, and Quality Assurance to ensure timely delivery against team and corporate objectives. (S)he will play an important role in the transfer of formulations and processes as well as facilitating phase-appropriate scale-up operations.
The successful candidate will also lead platform development activities as well as identifying, evaluating, and qualifying new technologies that define the future direction of Microbiome Drug Substance production.
Key Responsibilities include:
- Develop and qualify processes for cell banking, fermentation, harvest, and/or freeze-drying and related operations to ensure consistent and reproducible manufacture of Microbiome Drug Substances
- Lead experimental design, execution, and data interpretation, including compilation and review of documentation in laboratory notebook systems and complex technical reports
- Perform problem-solving and troubleshooting activities, as needed
- Lead activities for process optimization, platform development, technology evaluation, and continuous improvement efforts
- Supply Drug Substance materials for characterization and development activities within partner functions, including Research, Drug Product Development, Analytical Development, and Quality Control
- Build strong collaborative working relationships by communication of findings with internal and cross-functional teams
- Support the transfer of Drug Substance manufacturing operations to alternate sites, as appropriate, to assure continuity of supply
- Participate in the generation and review of master and executed batch records
- Identify and utilize expert consultants, where appropriate
Preferred Qualifications include:
- Ph.D. in a Life Science or related discipline with 0 – 2 years of relevant experience or M.S. and 8+ years of relevant experience, or B.S. and 10+ years of relevant experience for Scientist I; additional years of experience may qualify candidates for Scientist II.
- Deep knowledge of microbiology and aseptic techniques; experience with anaerobic bacterial culture highly beneficial
- Expertise with fermentation or cell culture, lyophilization and/or spray-drying technologies
- Understanding of DOE, statistical data analysis, and QBD in process development highly beneficial
- Familiarity with GMPs required; understanding and ability to implement regulatory expectations into process development activities
- Proficiency with analytical techniques, experience with microscopy and/or flow cytometry advantageous
- Strong professional, interpersonal, and communication skills
- Demonstrated mentoring, leadership, or management experience
- Ability to function with flexibility and respond rapidly in a fast-paced laboratory environment
- Capability to apply critical thinking to solve problems
- Attention to detail and excellent documentation and technical writing skills
- Experience with regulatory submissions (IND, BLA, etc.) advantageous
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. 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 great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
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.
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