Engineer, GMP Biotech Process Tech transfer; JP

Engineer, GMP Biotech Process Tech Transfer

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Basic Qualifications:

• Master's Degree - 0
  -2 years industry experience
• Bachelor's Degree - minimum of 2 years industry experience

Nice to have:

• Tech transfer experience
• Preferably from Bio Pharma Industry

Job Description:

Ideal candidate:
The ideal candidate for this role should have a bachelor's degree in any scientific or engineering discipline with 1 – 3 years professional working experience. Candidates with recent Master degree are also suitable if they bring strong soft skills. The candidate should possess solid working experience with standard software tools such as Microsoft Office. Experience with specialized software such as SAP or Smartsheet is desirable but can be learned on the job.

Biologic drug product knowledge is favorable. The candidate must excel in group management, deadline adherence, and meticulous documentation skills. This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time. Professional working experience outside of an academic setting is preferred.

As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at Thousand Oaks, CA which includes various production lines. The candidate will support senior staff in the planning, execution, and documentation of characterization, process validation and technology transfer projects.

The candidate will be primarily responsible for supporting execution of characterization studies to generate technical data packages using complex technology, organization of data and analysis of results, and compiling information in concise summaries while under supervision of senior staff. The candidate will coordinate with drug product teams to facilitate technology transfer and complete technical documentation. The candidate will assist with experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups.

Preferred Qualifications:

• B.S. in scientific or engineering discipline with 1‒3 years' relevant professional experience or M.S. in scientific or engineering discipline with 0‒2 years' relevant professional experience
• Familiarity with cGxP and experience in drug product / drug substance manufacturing or process development
• Knowledge of and hands-on experience with various drug product technologies
• Displays critical thinking, problem solving and independent research skills
• Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
• Excellent project management skills and ability to escalate relevant issues to project lead and line-management
• Strong cross functional team player with good communication skills (oral and written)
• Ability to work independently and as part of a team with internal and external partners
• Good computer and organizational skills with strong attention to detail
• Self-motivated with a positive attitude

Why is the Position Open?

Supplement additional workload on team

Top Must Have

Skills:

• Chemical Engineering, Biotechnology, and Pharmaceutical Science Industry related experience
• Has been working on GMP environment
• Preferably from Bio Pharma Industry

Responsibilities include, but are not limited to, the following:

• Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
• Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
• Support technology transfer leads during the transfer of drug products…