Senior Manager / Associate Director, Drug Product Development & Manufacture
Location: South San Francisco, California, United States
The Sr Manager/Associate Director, Drug Product Development & Manufacture will be responsible for drug product development for Assembly Biosciences' small molecule compounds. This individual will lead the early-stage drug product development & manufacturing activities including preformulation activities such as solid form characterization and solubility assessment, formulation development including drug product manufacturing to support non-clinical and clinical studies and author relevant quality modules of regulatory filling(s).
Key responsibilities include:
- Identify, select and manage third party CROs/CMOs with sufficient technical expertise to conduct development activities including solid form screening, material characterization, determine physicochemical properties, stability and excipient compatibility. Provide technical guidance in developing appropriate non-clinical and clinical formulations to support Tox studies and clinical studies.
- Oversee development activities at CMOs to ensure seamless execution of the work packages and delivery of drug product meeting all quality standards. Ensure all drug product development and manufacturing activities meet project timelines.
- Provide technical review and approval for batch records, development protocols and technical reports.
- Identify and lead resolution of complex technical issues during drug product development and clinical manufacturing.
- Work closely with internal colleagues and external partners in deviations, investigations, change management and other related issues, to ensure cGMP compliance.
- Author and review relevant Quality modules to support global IND/NDA filings. Provide technical justifications to address any regulatory questions.
- Interface effectively with cross-functional teams including quality assurance, analytical development, ADME/toxicology, clinical supply, clinical operations, and regulatory CMC.
- Identify and utilize external experts and consultants, when necessary.
Preferred Qualifications include:
- Bachelor’s degree in chemical engineering, pharmaceutical sciences, or related scientific field with 10+ years of drug product development experience in the pharmaceutical industry. Candidates at the Associate Director should have additional years of experience in combination with an advanced degree.
- Sound scientific understanding of polymorphism, physicochemical properties and novel drug delivery technologies to enable the developability of poorly soluble compounds.
- Must have hands-on experiences working in preformulation and formulation development along with in-depth knowledge on solid dosage form processing and analytical equipment.
- Demonstrates competency in the principles and practice of cGMPs and global regulatory requirements.
- Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Effective communication, interpersonal skills, collaboration and negotiation skills.
- Highly organized and efficient, close attention to details and able to orchestrate multiple projects simultaneously.
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is an ambitious clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world. We are currently focused on 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.
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 set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.
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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