Associate Director / Director, Drug Product Process Engineering and Validation
Location: South San Francisco, California, United States
The AD/Director, DP Process Engineering & Validation will be responsible for solid oral dosage form process optimization, scale-up, tech transfer and validation. Lead the late-stage DP development & manufacturing activities at CMOs to support late phase clinical studies, regulatory filling and DP commercialization for Assembly’s small molecule portfolio.
Key responsibilities include:
- Identify and select third party CMOs with sufficient technical expertise and manufacturing capacities (resources and equipment) to meet late phase clinical requirements and commercial volume for all HBV programs.
- Oversee clinical and commercial supply manufacturing activities at CMOs to ensure seamless execution of the work packages and delivery of drug supplies meeting all quality standards
- Apply QbD concepts and effective DoE approaches to generate and execute drug product process optimization/validation plans; Enable deep understanding of the manufacturing processes and possible impacts on drug product performance and quality attributes.
- Identify critical material attributes, define design space for unit operations to ensure process robustness and support tech transfer, scale-up, clinical and registration stability batch manufacture as well as process validation.
- Review, summarize and interpret process development data generated by CMOs; Conduct statistical design and analysis to establish the relationship between the key material attributes and process parameters with the product quality attributes.
- Proficiency in writing to prepare and review validation protocols, validation reports, continued process monitoring plans and statistical sampling plans, in support of product registration and post-approval changes.
- Identify and lead resolution to complex technical issues during clinical and commercial 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, packaging, clinical operations, regulatory and supply chain.
- Identify and utilize external experts and consultants, when necessary
- Perform other duties as assigned
- Advanced degree in chemical engineering, pharmaceutical sciences, or related scientific field with 7+ years (Ph.D.) or 10+ years (master’s degree) of late stage drug product development, technical operations, or commercial manufacturing experience in the pharmaceutical industry. Candidates at the Director level should have additional years of experience.
- A previous track record of solid dosage form late stage manufacture and commercial process tech transfer, scale-up, and validation. Experience in SDD manufacture process development, optimization and scale-up are highly preferred.
- Strong technical skills in process development of solid oral dosage forms, hands-on experience and sound understanding of major processing equipment and unit operations (e.g. Granulation, Fluid Bed Drying, Compression, Spray Drying, etc.) at pilot and commercial scales.
- Proficiency with QbD concepts and Design of Experiments, familiar with statistical tools for data analysis.
- Demonstrates competency in the principles and practice of cGMPs and global regulatory requirements.
- Experience on preparing regulatory documents for NDA filings
- 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 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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