|Location: Cambridgeshire||Salary: Negotiable|
|Sector: Pharmaceuticals, Medical Communications, Medical Devices, Life Sciences||Type: Contract|
|Contact: Zak Mendoza||Job Published: 14 days ago|
Drug Product Technology Transfer Engineer
6 Month Contract
Drug Product Technology Transfer Engineer needed for a highly respected Pharmaceutical organisation who are looking to employ an experienced and well-rounded Drug Product Technology Transfer Engineer that takes pride in their work with strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality and ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills.
What the role entails:
Some of the main duties of the Drug Product Technology Transfer Engineer will include:
- Work with Drug Substance/Drug Product Technical Stewards and SMEs from R&D, Quality, Validation with AZ and external partner sites to support technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.
- Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.
- Serve as Manufacturing /Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.
- Update project dashboards/presentations with project status to provide timely communication of status to internal team. Proactively identify risks, and develop / implement work plans to manage / mitigate / communicate risk to senior technical transfer leads.
- Work with CMOs to compile and trend DS/DP manufacturing process data during manufacturing campaigns.
- Note: The AZ team will be based in the US East Coast, CMOs receiving technology transfers are located in EU, and Far East. Will require ability to work flexible hours to support multiple global time zones.
What experience you need to be the successful Drug Product Technology Transfer Engineer:
- Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science& Technology/ Manufacturing/ Process Engineering/ Quality. Prior experience in Drug Substance tech transfers preferred.
- S with 10+ years of experience
- S. with 6+ years of experience
- PhD with 4+ years of experience
- Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.
- Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills
- Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations
- Ability to work in a complex, dynamic, global environment
This really is a fantastic opportunity for a Drug Product Technology Transfer Engineer to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.