Associate Director, Drug Process Development & Manufacture
Location: South San Francisco, California, United States
The key focus of this role is oral-drug product process development and optimization, scale-up, tech transfer & validation, and clinical supplies manufacturing activities at CMOs to support on-going clinical trials as well as commercial for our small molecule portfolio.
Key Responsibilities include:
- Oversee drug product manufacturing activities at CMOs to ensure cGMP compliance, drug products meeting all quality standards, and timely delivery of clinical supplies from Phase 1 through commercial launch.
- Understand QbD concepts, apply effective DoE approaches to generate and execute process development/optimization plans, enable deep understanding of the manufacturing processes and possible impacts on drug product critical quality attributes.
- Review, summarize and interpret process development data generated by CMOs, conduct statistical design and analysis, identify critical material attributes, define design space for unit operations, ensure process robustness and support tech transfer, scale-up, and process validation.
- Identify, select and manage third party CMOs for drug product manufacturing. Responsible for proposal writing, contract negotiation and budget planning.
- Provide technical expertise to CMOs to trouble-shoot drug product manufacturing process issues.
- Technical review and approve master and executed batch records, sampling plans, validation protocols and technical reports.
- Work closely with internal colleagues and external partners in deviations, investigations, change management and other related issues.
- Author and review the drug product manufacturing process related sections of regulatory submission documents. Provide technical justifications to address any regulatory questions.
- Interface effectively with cross-functional teams including quality assurance, drug substance, clinical operations, Regulatory and Supply Chain.
Preferred Qualifications include:
- Advanced degree in pharmaceutical sciences, chemical engineering or related scientific field with 7+ years (Ph.D.) or 10+ years (master’s degree) of drug product development experience in the biopharmaceutical industry.
- Strong technical skills in process development of solid oral dosage forms, hands-on experiences and sound understanding of major process 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.
- The position may require travelling up to 20% of the time.
- Experience working with contract organizations for drug product development, manufacturing and testing.
- A previous track record of solid dosage form late stage process development, optimization, scale-up, tech transfer and validation.
- Experiences on regulatory document preparations for NDA filing
- 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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