Manager, Process Development and Manufacturing
Location: South San Francisco, California, United States
The Manager of Process Development and Manufacturing will primarily manage high priority chemical development and manufacturing activities that support chemical development of Assembly’s small molecule API projects at various stages of clinical development.
Key responsibilities include:
- Apply working knowledge of chemistry, process development, chemical development, and GMP manufacturing to support Assembly’s small molecule API assets.
- Prioritize and actively manage development and manufacturing tasks both internally and externally to minimize risk to project timelines and objectives.
- Serve as point of contact and actively manage Assembly’s CMOs, CDMOs, and CROs to achieve project and departmental objectives.
- Manage multiple projects simultaneously at different stages of drug development.
- Communicate issues to line manager and project teams in a timely manner.
- Plan activities and prepare RFPs, SOWs, tech transfer packs, and any other required documentation to ensure vendor progress.
- Review vendor documentation including business, accounting, quality, and all technical documentation as appropriate.
- Create, organize, analyze, and disseminate information and documents required by Assembly and their partner CROs/CMOs to support ongoing development activities and manufacturing within a GMP compliant environment.
- Provide detailed technical reviews (and approval where appropriate) for all relevant documents that support development, manufacturing, quality, and eventual regulatory filings.
- Maintain productive business relationships with CROs and CMOs appropriate for managing development and manufacturing tasks on time and within budget.
- Identify, propose solutions to, and quickly solve CMC related problems.
- Participate in or lead deviation investigations, change management, and generally contribute to other quality related issues.
- Identify procedural and systemic gaps internally and with external partners to implement improvements and best practices.
- Interact proactively with internal colleagues from CMC, Quality Assurance, and Regulatory Affairs, Project Management, and non-clinical as needed.
- Participate in relevant CMC meetings and lead discussions where appropriate.
- Receive team feedback and instructions to efficiently manage assigned projects with minimal supervision.
- Work within a team environment to build productive relationships and solve problems where obvious solutions are not readily available.
- MS degree in chemistry.
- 3+ years of experience within a chemical development environment and preferably interacting with or managing CROs/CMOs activities.
- Must possess working knowledge of organic chemistry.
- Knowledge of CMC and drug development.
- Some working knowledge with FDA and ICH guidelines for INDs/NDAs/MAAs and cGMPs.
- Experience within SharePoint, VEEVA, MS Teams, or other collaboration and document organization systems is a plus.
- Experience with MS Office and related tools.
- Some experience with MS Project would be helpful.
- The preferred candidate will be self-motivated, can think independently, and possess the flexibility to undertake job responsibilities which might be in addition to their assigned responsibilities.
- Excellent oral and written communication skills.
- Good attention to detail and time management skills.
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology.
We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn’s disease and Irritable Bowel Syndromes with potential total development and commercial milestones of up to $2.8 billion. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.
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 to our dynamic team of great people who are driven to transform the lives of patients.
Assembly Bio is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly Bio has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
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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