Engineer, Biotech – Hybrid; JP

Engineer, Biotech – Hybrid

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

This process development engineer will support the commercialization and the life cycle management of drug products. The engineer will support the planning, design, implementation, and documentation of process development laboratory studies related to drug product manufacturing. This person will provide support to clinical and commercial fill / finish manufacturing operations. The engineer will participate on global multi-functional teams working in a highly matrixed team environment.

Responsibilities include authoring, reviewing, approving, data verifying technical protocols, reports, product impact assessments, risk assessments, regulatory submissions, and regulatory response to questions. On site laboratory work will be required. Execute process development scale experiments related to manufacturing unit operations and analyzes product quality data.

Top Must Have Skills:

• Relevant STEM degree (e.g. Chemical Engineering, Biomedical Engineering, Biochemical Engineering, chemistry, pharmaceutical sciences, or other), science background
• Experience with technical writing and communication
• Prefer 1-2 years of experience at least w/bio tech background

Day to Day Responsibilities:

• Scaled down drug product manufacturing process characterization studies (freeze thaw, mixing, formulation, filling, filterability, product quality assays, etc.)
• Data verification
• Technical writing of protocols, reports, technical assessments
• Support regulatory writing, marketing applications, response to questions
• Create and deliver progress reports and presentations

Red Flags:

• No science degree/background
• Moving jobs frequently (e.g. risk they won't complete 1+ year of work)
• Poor grammar/formatting resume

Interview process:

• First phone screen
• Panel interview (2 hrs of candidates time)