Process Associate, Clinical Manufacturing - Pharma/Device Combo
San Francisco Metro Area, CA
A member of the Process Engineering team engaged in supporting process development and optimization. This position will support both early stage and late stage development groups. The candidate who fills this position will be expected to contribute to the manufacturing and development of pulmonary drug formulations in R&D, GLP and GMP settings.
EDUCATION / EXPERIENCE:
- Bachelor s degree in physical science, chemistry, chemical science, material science, engineering or related field preferred.
- 2+ years of experience working in a pharmaceutical production facility preferred
- Previous experience with assembly/maintenance of electronics and/or mechanical hardware
- Good oral and written communication skills with an ability to maintain documentation integrity to GMP standards
- Ability to work comfortably with Excel spreadsheets (e.g. - understands how to create/use formulas, links, and graphs).
- Ability to conduct a wide range of manufacturing efforts in GLP, GMP and R&D contexts. Experience in GMP is preferred.
The principal objective of this position is to build, test, operate and maintain manufacturing equipment in the R&D and clinical facility as well as support development studies in the commercial facility. Some of the responsibilities of this position include:
- Execute particle process operations in R&D and early clinical cGMP facility and support development studies in the commercial GMP facility, including:
- Operate feedstock equipment, spray dryer, jet mills and perform collector change outs
- Dispense raw materials; sample powder for testing
- Performs routine physical characterization of products. (e.g. powder and feedstock characterization)
- Tabulates, documents, and assists in interpretation of process data
- Assists in troubleshooting of process-related issues
- Process equipment related responsibilities:
- Rinse-in-Place, manual and washer based cleaning of processing equipment (including spray drying, feedstock preparation, jet milling, MDI filling, glovebox) and processing areas
- Disassemble and Assemble R&D and GMP Clinical equipment
- Support maintenance of spare parts inventory and materials inventory
- Conduct equipment preventative maintenance activities
- Support equipment qualification activities
- Additional Responsibilities:
- Effectively communicate technical issues; perform equipment troubleshooting. Transcribe process data into spreadsheet templates
- Prepare summaries of data sets using Excel (e.g. calculate means, percentages)
- Provide feedback for areas of improvement; including process work flow
- Provide feedback on process part integrity and upkeep, and
- Document all activities per applicable protocols, SOPs and cGMPs in associated lab notebooks or Batch Production Records
- Maintain a safe working environment
- Observe and follow all safe operation practices
- Routinely inspect facility safety equipment
- Maintain a clean and clutter-free working environment
- Fast learner: Ability to quickly understand tasks and work independently to complete assignments. We are looking for individuals who actively apply their knowledge and are enthusiastic to learn about our production technologies.
- Highly organized: This role involves the assembly of many parts and instruments using various tools for several different projects. Additionally, the process technician will be responsible for filing paperwork such as material/surface certs, calibration, etc. Prefer candidate that will take ownership over maintaining a highly organized work environment.
- Versatility: You are able to identify problems and address them quickly. Comfortable working both hands-on and with documents in a fast-paced environment, at times with external vendors and consultants.
- Passion: You take pride in helping patients with new drugs and are energetic, positive and hardworking. You enjoy solving problems and are self-motivated.
- A team player: You believe that you can achieve more on a team that the whole is greater than the sum of its parts.
- Have sufficient dexterity to don and doff clean room clothing over normal work attire.
- Be able to wear respiratory protection for shifts up to the length of time prescribed by the California Occupational Safety and Health Administration.
- Be able to work with various chemicals identified under California Proposition 65, once given proper protective equipment.
- Be able to lift up to 50 pounds of weight repeatedly and safely.
- Be capable of operating a computer and sitting for extended periods.
- Be willing to work swing shift or early shift occasionally pending campaign requirements. (Primary function of job will be normal shift)