What are the responsibilities and job description for the Manufacturing Technician position at Lyndra Therapeutics?
Lyndra Therapeutics is a clinical-stage biopharmaceutical company that is making daily pills a thing of the past. Our team has developed the first ultra-long acting pill that lasts a week or longer and can provide a wide range of medicines in a familiar oral capsule form. Our near-term focus is on addressing unmet needs where compliance is a documented issue and weekly or monthly doses would improve medication adherence and health outcomes. Lyndra’s current pipeline includes therapies for Alzheimer’s disease, HIV, opioid use disorder and schizophrenia.
Reporting to the Manufacturing Engineer/Manager, the Manufacturing Technician is responsible for manufacturing Lyndra’s novel oral dosage products to support clinical through commercial needs. The manufacturing team is responsible for manufacturing clinical trial supplies and process development, scale-up and transfer to commercial production. This successful candidate will work closely with other manufacturing Technicians/Operators, Quality, Development, EHS, Supply Chain, the Quality Control Lab and a diverse set of colleagues to support company manufacturing goals. We are seeking people with exceptional people skills who want to work in a supportive fast-paced environment.
Responsibilities
- Manufacturing and production support of novel extended-release drug delivery technology including GMP operation of manufacturing equipment
- Polymer drying, blending and extrusion
- Automated and manual assembly of polymer-based dosage forms using plastic welding techniques
- Powder blend granulation and capsule coating
- Mechanical testing on polymer-based dosage forms
- Applying chemical and/or mechanical engineering principles to optimize manufacturing process to support clinical and commercial manufacturing.
- Batch record drafting, execution and review of executed batch records.
- Apply lean principles (6 Sigma, 6S, QbD, etc.) principles to continuously improve operations and drive continuous improvement behaviors
- Design and execution of R&D experiments and process development
- Supporting the development team with R&D and late-stage development projects
- Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP).
- Measure and weigh powders/solvents.
- Provides training support for new procedures and on boarding support for new Technicians/Operators.
Background & Experience
- Bachelor’s Degree in a technical field related to polymers, chemical or mechanical production or,
- Associates Degree and 1-3 years in a technical field related to polymers, chemical or mechanical production (biotech or pharmaceutical manufacturing experience preferred) or,
- HS diploma (or GED) and 7 years in mechanical production or manufacturing experience (biotech or pharmaceutical manufacturing experience preferred)
- Hands-on manufacturing operations skills required
- Ability to follow and execute instructions required
- Strong attention to detail required
- Strong trouble-shooting skills required
- Ability to work independently and as part of a team required
- GMP experience is a plus, ISO-8 or higher clean room experience is a plus