Lead Manufacturing Operator, Drug Product
Location: Groton, Connecticut, United States
The Lead Manufacturing Operator, Drug Product will perform all hands-on operations (GMP and development) of pharmaceutical dosage forms used to manufacture solid oral dosage forms.
Specific responsibilities include, but are not limited to:
- Perform hands-on operations for pharmaceutical manufacturing of solid oral dosage forms, including, but not limited to, dispensing, blending, milling/screening, encapsulation, tableting, banding, coating, weight sorting, packaging, and labeling etc.
- Perform equipment set-up, break-down, and cleaning, including appropriate care and storage of all change parts
- Manufacture drug product batches (development and GMP) in strict accordance with manufacturing batch records
- Perform manufacturing activities for formulation scientists in the development of robust and stable pharmaceutical drug products
- Develop and improve the requirements for in-house drug product development and manufacturing capabilities.
- Comply with all GMP procedures / requirements and Site safety procedures / requirements
- Perform IPC and analytical testing as needed
- Procure, receive supplies necessary to perform work, including excipients, components, laboratory supplies, etc.
- Perform studies and/or activities necessary for process optimization and continuous improvement to assure robust and cost-effective manufacturing processes.
- Lead troubleshooting, deviations, and investigations, as required
- Write and review SOPs
- Write and review batch records
- Understand and practice good documentation practices
- Document all work in electronic laboratory notebook or other acceptable forms (e.g., batch records)
- Build and maintain a strong cooperative working relationship with colleagues in Drug Product, Drug Substance, Analytical, and Quality
- H.S degree with 7+ years’ experience in pharmaceutical industry with hands-on knowledge of pharmaceutical processing equipment for solid oral dosage forms, including the ability to set-up, operate, and troubleshoot equipment
- 5+ years hands-on experience working in a pharmaceutical GMP environment for solid oral dosage form manufacturing
- Ability to use personal protective equipment, as required
- Familiar with all aspects of drug product development for solid oral dosage forms
- Motivated self-starter who can work independently with moderate supervision
- Willing to learn
- Excellent professional and interpersonal skills
- Good communication skills
- Ability to work efficiently and cooperatively in a small laboratory/manufacturing environment
- Goal oriented and ability to deliver on timelines and commitments
- Exhibits a proactive, transparent, and rigorously objective confidence in all aspects of manufacturing operations for solid oral dosage forms
- This position involves frequent moving of heavy equipment and requires the capability to safely lift, move and maneuver equipment.
- The nature of the work requires intermittent prolonged periods of standing or sitting.
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’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 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 great people who are driven to transform the lives of patients.
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.
Assembly 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 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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