Associate Specialist, Quality Control (Microbiome)
Location: Groton, CT
Working closely with cross-functional teams, the Associate Specialist will prioritize and execute testing activities, as well as author technical protocols, reports, and other documents, as applicable. The successful candidate will be tasked with executing hands-on laboratory testing in support of process development, characterization activities, specification, and stability testing using microbiology, flow cytometry, and/or molecular biology assays such as qPCR. Supporting development and qualification activities for new methods and troubleshooting of existing methods are further core competencies of the role.
The Associate Specialist will be expected to function independently with minimal supervision and will assist in establishing capabilities within a functional laboratory. This may include evaluating and qualifying new methodologies to expand the internal capabilities of the Quality Control function. Support of laboratory investigations, deviations, and associate documentation is also expected.
Key Responsibilities include:
- Independently plans and executes experiments and testing in support of project goals and non-routine activities
- Critically evaluates technical needs for experimental outcomes
- Mentors junior colleagues, as needed
- Collaborates in development, qualification, and testing execution of robust and reproducible analytical methodologies for evaluation of product quality attributes in support of process development, manufacturing operations, stability, and characterization studies
- Maintains familiarity with relevant scientific literature and pharmacopeia; evaluates and ensures compendial compliance of applicable methods
- Participates on cross-functional teams relating to process development, communicates results to team members
- Executes laboratory investigations (OOT, OOS, deviations, etc.), including troubleshooting activities, as necessary
- Authors technical documents including protocols, reports, etc.
- Identify, evaluate, and qualify new technologies related to microbiological agents
Preferred Qualifications include:
- B.S. in a Life Science or related discipline with 8+ years of experience, or M.S. with 6+ years. Preference given to candidates with industry experience
- Direct experience with microbiological testing, flow cytometry, and/or molecular biology techniques
- Knowledge of other techniques such as Karl Fischer, and dissolution/disintegration is highly beneficial; familiarity with general techniques such as spectroscopic and/or spectrophotometric methods is desirable
- Experience in method execution, including development and qualification activities for new methods, and troubleshooting of existing methods
- Specific skills with anaerobic cultures are highly desirable
- Hands-on experience with applicable analytical instrumentation, including the ability to set-up, operate, and troubleshoot equipment
- Demonstrated ability to independently author technical documents
- Strong knowledge of cGMPs and cGDPs
- Motivated self-starter who can work independently with minimal supervision
- Excellent professional and interpersonal skills as well as aptitude with oral and written communications
- Ability to work efficiently and cooperatively in a fast-paced environment while maintaining quality expectations
- Goal-oriented and capacity to deliver on timelines and commitments
- Exhibits a proactive, transparent, and rigorously objective confidence in all aspects of work activities
- Familiarity with the compliance expectations of the Quality Control environment; knowledge of good documentation practices and attention to detail
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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