Skills:

Company: RoosterBio

Location: Frederick, MD

Industry: Manufacturing

EmploymentType: Full-Time

Description:

We are looking for a friendly, dedicated, well organized, highly motivated and driven individual to join the team at RoosterBio and fill a role focused on process and product development activities and enhancing our culture. The incumbent will play a key role in ensuring that RoosterBio products live up to the label statement “Made with Care in Frederick, MD”. This position is critical to the RoosterBio business with responsibilities in product design, testing, release and tech transfer to manufacturing. These responsibilities are central for producing high quality products for our customers and to ensure a good experience with our products. We are looking for team-oriented person who can take on increasing responsibilities as RoosterBio grows rapidly over the next 1-3 years


Requirements:
  • Projects a positive, proactive, collaborative, and helpful attitude.
  • Action oriented, results driven, and able to accomplish project objectives and meet or exceed expectations.
  • Experience in Biotechnology, Medical Devices and Cell Biology within GMP operations.
  • B.S./M.S. with 1-3 years of relevant industry experience or A.A. with 4 – 6 years of relevant industry experience.
  • Background in lab operations in the biotech/pharma industry.
  • Experience in drafting and revising SOPs.
  • Experience with Process Improvement Activities (Lean/5S/Six Sigma, etc.).
  • Desired, but not required, experience in mammalian cell culture.
  • Adapts to changes, demands, schedules, and priorities while maintaining a positive attitude.
  • Accepts personal responsibility for producing results (individually and as a team).
  • Exhibits a high level of professionalism at the workplace.

Duties:

Essential Job Duties

 Manage and execute basic laboratory activities including organizing materials, equipment
monitoring, equipment maintenance and facility cleaning.
 Order and manage raw materials; assist with the storage, distribution and shipment of released
products.
 Manage key relationships which include OEM suppliers, vendors, storage and distribution partner
 Collaborate with sales team to provide customer support.
 Draft, review and update Standard Operating Procedures as needed.

Secondary Job Duties
 Perform root-cause analysis for all non-conformance reports and deviations. Develop and
implement corrective and preventative actions (CAPAs).
 Assist with the design and execution of Quality Systems for current and future Good Manufacturing
Practices (cGMP) and other applicable regulations as required for manufacturing, facility operations,
raw material procurement, storage and distribution
 Assist during manufacturing of routine cell culture and aseptic fill procedures.
 Perform other tasks as assigned by management.