To design and implement manufacturing processes, instrumentation, and equipment from the laboratory through pilot plant and manufacturing scale up
To provide expertise in cell culture, engineering, design, and process and/or scale up
To assist the manufacturing operation in problem solving with regard to equipment and systems
To develop and recommend new process formulas and technologies to achieve cost effectiveness and improved product quality
To recommend processes for the production of therapeutic products
Responsible for establishing operating equipment specifications and improving manufacturing techniques
Responsible for performing calibration and validation of equipment and systems
Responsible for assisting in equipment selection, specifications, and negotiation of competitive pricing
Responsible for maintaining documentation pertaining to qualification and validation
Responsible for developing procedures and protocols
Responsible for serving as information resource for validation contractors and vendors
Responsible for participating in new product scale up, process optimization, technology transfer, and process validation activities
Responsible for interfacing with all applicable departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- PHD in chemical or bio-chemical engineering, or equivalent
- 2 to 4 years of applicable industrial experience
- Process validation of biological products required
- GMP engineering experience preferred
- Manufacturing of biologics experience preferred
PHYSICAL DEMANDS :
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- May lift up to 50 pounds
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 50 % travel.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 15 months ago