Manager, Operations

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

 Manage the Tech Transfer of new manufacturing processes. Coordinate the development
of new quality control testing procedures with the Associate Director of Operations and individual
project managers.
   • Plan and direct the development of new manufacturing process in collaboration with the Director of
Operations and project sponsors. This will involve the design and execution of required process
development experiments and analysis of experimental results. This includes the evaluation of required
new biological materials such as viral vectors, mammalian cell lines and associated material transfer
requirements, health and safety precautions, and required storage and use conditions. This will also
involve the drafting and implementation of required engineering design systems and associated
specification technical documents
  • Identify required manufacturing equipment. Coordinate the purchase, installation, and drafting of
required validation protocols and Standard Operating Procedures (SOPs). This will include a
comprehensive verification that new equipment engineering specifications comply with facility design
parameters and other facility equipment
  • Identify new raw materials required for new manufacturing processes, identify appropriate vendors
for purchase, and draft required raw material specification documents according to current SOPs. Where
needed, this will include the drafting and/or review of engineering design specifications for materials .
  • Develop new custom bioprocess reagents as needed, including contracting with contract
manufacturers for production and testing. Where needed, this will include the drafting and/or review of
engineering design specifications for materials
  • Works with the Process Development Group for the transfer of final process to GMP
Manufacturing, including the drafting and issuance of production batch records according to current SOPs.
Where needed, this will include the drafting and/or review of engineering design specifications for both
process and associated equipment

Oversight of Manufacturing Staff and of Manufacturing Operations.
  • Oversee the training and daily job performance of all manufacturing personnel according to current
SOPs
  • Develop daily, weekly, monthly, and annual manufacturing schedules in coordination with the
Director of GMP

$70,600-$80,200

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

EDUCATION & TRAINING
- Master’s degree in a biotechnology/life science or in engineering, and at least four years of direct experience
in a clean room environment with GMP involvement.
EXPERIENCE
- 3+ years of related experience in cell processing and Viral Vector Production

KNOWLEDGE
- Working understanding of Gene and Cell Therapy concepts
-Experience with clean room work and GLP/GMP regulations, as well as mammalian cell culture and
virology

SKILLS
- Detail-oriented
- Strong organizational skills

PHYSICAL QUALIFICATIONS
- Must be able to lift items weighing up to 50 pounds

Application must be submitted by 11:55 p.m. (ET) of the posting end date.