- Job date: Fri, 15 Jan 2021 08:41:31 GMT
- Expected salary: $139429.98 – 180438.8 per year
- Job title: Director/Senior Director Process Sciences
- Company: Hobson Prior
- Location: Gaithersburg, MD
- Providing technical leadership to generate, review, and approve laboratory data to support investigations and troubleshooting of drug substance processes being operated at internal and external manufacturing.
- Contribute to the writing and reviewing of documents for INDs and regulatory section submissions.
- Collaborate with other CMC team members to build and execute the CMC development plan.
- Responsibility for continued process verification, including process monitoring programs across multiple manufacturing programs and manufacturing sites.
- Responsible for technical oversight of supplier-initiated changes and DS process changes.
- Lead and develop a team of laboratory personnel.
- Provide leadership and direct support for tech transfer to manufacturing teams, including the preparation of draft batch records.
- To plan and execute confirmation runs (or manage and oversee execution of confirmation runs at external sites).
- Prepare or oversee the preparation of tech transfer reports and participate in the approval to move towards GMP manufacturing.
- In conjunction with site management, make key process related decisions when necessary.
- Establish appropriate process performance monitoring systems and assist in evaluating process performance.
- Any other assigned duties.
- Ability to succeed in a team-oriented environment under very dynamic conditions.
- Ability to collaborate with key stakeholders across a wide set of business disciplines.
- Excellent record keeping abilities to adequately record, analyse and document data generated in support of regulatory requirements.
- Demonstrated verbal and written skills in communicating scientific and technical information.
- Capable of performing multiple functions in a fast-paced environment.
- Strong technical protocol/report writing, and good organization skills are required.
- Master’s degree in engineering or life sciences.
- You will have 10 or more years of relevant experience in cGMP biologics manufacturing.
- Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.
- Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.
- Proficient in Window based software including Excel, PowerPoint and Word.
If you are interested in learning more or applying to this exciting opportunity then please click “Apply” and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select “Contact me” at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy