Job Title: Manufacturing Science and Technology Drug Product SME /Process Engineer
Work Location Remote Role
Duration: 9 Months (Possibility of Extension) on W2
Work will be remote due to C19, but preference is to be located near a drug product mfg site (Kalamazoo, McPherson, RM, Sanford -ASAP start -PM experience would be a plus -non-routine investigations -Green belt would be a plus -Tech service background -Sterile injectables, biologics -operational background)
The individual selected will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements.
This position specifically involves the management of technical and development activities for product transfers to and from the client network and contract manufacturing organizations (CMOs), development / improvement of manufacturing processes for new and existing sterile injectables products across all business units, and manufacturing site support for critical investigations.
This position requires effective and direct communication skills, bold leadership and facilitation, and the ability to influence and integrate various colleagues from all levels of the organization.
As a MSAT Subject Matter Expert your responsibilities could include:
Providing technical subject matter expertise and issue resolution for major/moderately complex investigations for aseptic sterile injectables, biologics and vaccines and assisting in completing all required documentation in a timely manner
Participating in the Co-Development process, particularly in Late Stage Development/Phase 3 Clinical Supply to commercialization and continued product support
Applies technical knowledge and skills to achieve goals of the department
Preparing, reviewing, and may approve documents including protocols, reports, technical assessments, memos, study plans, and meeting minutes, as needed
Collaborating with wet and analytical labs (e.g., Experimental Pilot Plant in Puurs) to execute exploratory or feasibility studies
Masters with minimum of 2+ years or Bachelors with minimum of 3+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
Sterile injectables/vaccines formulations and strong background in filling operations of Drug Product
Operations or Tech services experience
Experience in particle science/suspensions is an advantage
Experience with lyophilization is an advantage
Black Belt or Green Belt experience is an advantage
Ability to execute laboratory studies with nominal guidance and experience with aseptic techniques including working in biosafety cabinets, handling sterile liquid transfers, and sterile manipulation of drug substances for use in small- and intermediate-scale formulations
Knowledge of cGMP requirements and compliance
Excellent communication and technical writing skills
Working knowledge of Minitab or JMP preferred
Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities
Ability to think creatively and find innovative solutions is a plus kills: Name Required Experience • Experience with lyophilization is an advantage No 1 - 2 Years • Knowledge of cGMP requirements and compliance No 1 - 2 Years • Operations or Tech services experience No 2 - 4 Years • Sterile injectables/vaccines formulations and strong background in filling operations of Drug Product No 1 - 2 Years • Working knowledge of Minitab or JMP preferred No 1 - 2 Years Green Belt experience is an advantage No 1 - 2 Years Background Checks
What is the minimum education experience required?: Bachelor’s degree in Engineering, Chemistry, or Biology
4+ years exp.