Job Title: Senior Process Engineering ManagerLocation: Middletown, Delaware Exempt/Non-Exempt: Exempt
Exciting Greenfield facility to manufacture small molecule active pharmaceutical ingredients (drug substances). In addition to small molecule active pharmaceutical ingredient manufacturing, this will include capabilities for oligonucleotides, peptides and high potent drug substances.
1. Be a subject matter expert in the development and implementation of the drug substance programming and process development.
2. Be responsible for interacting with the engineering design team in the development and alignment of the process with the other Global facilities during design, construction and qualification phases of the drug substance facility.
3. Responsible for the transfer and validation of drug substance manufacturing processes to the facility.
4. Collaborate with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process design, commissioning, qualification, and validation documentation is reviewed and approved.
5. Cooperate with the Site Leadership Team, and will support the creation of a culture that aligns with the Company’s core values of integrity & dedication, working together, doing the right thing, and doing it right.
6. The individual will ensure compliance with all Company, local, state, and federal policies and procedures and international authority requirements for quality and compliance.
Job Type: Full-time
Pay: $73,734.00 – $125,000.00 per year
Work Location: Remote
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