Be part of something great and make history in the process.
We are seeking a highly skilled and motivated Drug Product Development Engineer III to work in a team developing a sterile drug product processes that will enable clinical and future commercial supply.
Applicants should have experience in aseptic processing, tech transfer, visual inspection, and fill/finish process development.
This person will be responsible for supporting technical development, transfer of fill and finish activities, both internally and with Contract Manufacturing Organizations (CMOs) and contribute to development activities supporting DP investigations/deviations.
location: NORWOOD, Massachusetts
job type: Permanent
salary: $95,000 - 105,000 per year
work hours: 8am to 5pm
Here's What You'll Bring to the Table:
- Oversee processes related to fill/finish packaging, labeling, and logistical support for clinical trial products, as well as large scale manufacturing.
- Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
- Develop processes suitable to ensure long-term stability of bulk and vialed drug product.
- Serve as subject matter expert on complex aseptic liquid and lyophilization filling applications. Equipment includes state-of-the-art, highly automated systems, as well as traditional, legacy systems.
- Act as the sending unit for technology transfer of drug product processes, both internally and to external CMOs. Serve as person-in-plant, where applicable.
- Support scale-up/scale-down of drug product manufacturing (e.g. Fill/finish, Freeze/thaw, Lyophilization)
- Implement screening, sizing, implementation, and phase-appropriate validation activities for sterilizing grade liquid filters in support of fill finish activities.
- Develop robust procedural controls for non-GMP filling operations.
- Serve as subject matter expert on particulate control and visual inspection processes across the fill/finish operations.
- Ensure that assigned processes are cGMP compliant and are designed to meet the regulations of the U.S FDA and the EMEA.
- BS/MS in Pharmaceutical Engineering, Chemical Engineering or related Scientific/Engineering field.
- Minimum 4-8 years of Biopharma, Biopharmaceutical, Pharmaceutical, or Biotechnology industry experience.
- Hands-on experience with aseptic liquid filling of vials. Familiar with current varieties and suppliers of parenteral vials and stoppers.
- Hands-on experience with best current practices and trends in disposable sterile technologies.
- Experience with process scale-up/scale-down and technology transfer of FDA-regulated manufacturing processes
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Knowledge of GMP regulations, Process Validation/Qualification principles, and aseptic processing principles
- Hands-on experience with sterile filtration unit operations and a variety of filter membranes and manufacturers. Experience working with filter manufacturers on the design filter validation studies is a plus.
- Preferred: Hands-on experience with aseptic lyophilization and aseptic filling of pre-filled syringes
- Preferred: Fluent in PDA Technical Reports 22, 26, 60, and 79
- Preferred: Experience with nanoparticle formulations
- Preferred: Knowledge of statistical design of experiments (DoE) and analysis
- Preferred: Knowledge of nucleic acid chemistry and biology
- Preferred: Contract fill finish manufacturing experience
The essential functions of this role include:
- working up to 2 hrs of overtime per week
- Experience level: Experienced
- Minimum 7 years of experience
- Education: Bachelors (required)
- Drug product development (6 years of experience is required)
- GMP regulations (6 years of experience is required)
- Aseptic Manufacturing (4 years of experience is required)
- Sterile Fill-Finish (4 years of experience is required)
- Process scale-up/scale-down (4 years of experience is preferred)
- Late-stage product development (4 years of experience is preferred)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.