Senior Scientist, Formulation (Drug Product Development, Microbiome)
Location: Groton, CT
The Senior Scientist, Formulation (Drug Product Development, Microbiome) will be responsible for the end-to-end Drug Product Development of Live Biotherapeutic Products (LBPs). It is expected that the Scientist I or II will work closely with the Drug Substance, Analytical, Quality Control, Preformulation, Drug Product Manufacturing and Quality Assurance teams to facilitate the development of robust, scalable and reproducible formulations and processes for LBPs. This is a hands-on position in which the Scientist I or II is expected to work with instruments and equipment in a laboratory environment.
Key Responsibilities include:
- Formulation development and optimization, process development and optimization, scale-up, technology transfer of Live Biotherapeutic Products (LBPs).
- Independently design and perform hands-on experiments on oral solid dosage unit operations, including, but not limited to, blending, roller compaction, encapsulation, banding, coating, and packaging.
- Independently design and perform sophisticated experiments using DOE, statistical tools for data analysis and principles of Quality-by-Design for Drug Product Development.
- Design development stability strategies, including selection and technical justification for packaging materials.
- Assist and contribute to studies and/or activities in a Quality-by-Design paradigm for formulation and process optimization as well as for continuous improvement to assure robust and cost-effective manufacturing processes.
- Keep up-to-date on technology advancements and make recommendations to expand in-house technology capabilities (formulation and process) at Groton, CT laboratory location, including defining user requirements and procurement of equipment/instrumentation necessary to perform formulation and process development activities.
- Identify and manage expert consultants and third-party development organizations for technical issues, as needed, including consultant/vendor evaluation and selection, request for proposals (RFP), quotations, service agreements, and scheduling and oversight of experiments/activities.
- Train and mentor junior level scientists, as needed.
- Support GMP manufacturing, packaging, and/or labeling operations, as needed.
- Understand and practice good documentation practices. Document all work in electronic laboratory notebook(s) or other acceptable forms (e.g., batch records).
- Write and review SOPs, development protocols, and technical reports.
- Assist with troubleshooting, deviations, and investigations, as requested.
- Contribute to preparation and review of regulatory documents for submission to FDA and other regulatory authorities.
- Lead or contribute to invention disclosures and patentable advancements.
- Build and maintain a strong cooperative working relationship with colleagues in Drug Substance, Drug Product, Analytical, and Quality.
Preferred Qualifications include:
- Ph.D. in Pharmaceutics or related discipline with 5+ years of relevant experience. Non-Ph.D. candidates with a Master's degree, with 13+ years of relevant experience, will be considered. Key relevant experience should include hands-on formulation and process laboratory experience to support solid oral dosage forms.
- Hands-on experience with pharmaceutical unit operations, equipment and instrumentation to support formulation activities for solid oral dosage forms.
- Hands-on experience in independently running small-scale processing equipment for solid oral dosage forms is very important for this role.
- Understanding and incorporation of DOE, statistical data analysis and QBD into product development will be a huge plus.
- Demonstrated ability to write technical reports and other technical documentation (e.g., protocols, SOPs, etc.).
- Understand and implement FDA and ICH requirements into Product Development (e.g., Quality-by-Design) for IND, CTA, IMPD, NDA, BLA, PAI and Quality submissions.
- Knowledge of pharmaceutical GLPs and GMPs, especially as related to solid oral dosage form manufacturing.
- Motivated self-starter who can work independently with minimal supervision.
- Excellent professional, interpersonal skills and communication skills.
- Ability to work hands-on efficiently and cooperatively in a small laboratory environment.
- Goal oriented and ability to deliver on timelines and commitments.
- Exhibits a proactive, transparent, and rigorously objective confidence in all aspects of work activities.
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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