Engineer Associate Director Lead Drug Substance Facility; JP

Engineer Associate Director – Start-Up Lead New Drug Substance Facility

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

Job Description:

Candidates will be thoroughly screened for their experience and basic qualifications. We are NOT looking for an SME in a specific area but instead an independent experienced leader who can come into a new and upcoming site with a broad spectrum of knowledge and experience to be utilized amongst site teams.

Highly versatile and experienced subject matter expert able to contribute as an individual or to lead teams across a wide range of drug substance technical areas.

• Responsible for aspects of the successful preparation, strategy, and execution of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ) during the start-up a of new Drug Substance production facility.
• Responsible for enabling CMC Regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting.
• The qualified candidate will lead technical teams across various disciplines and objectives.
• Additional Responsibilities:
• Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities and Engineering;
• Create and assess process technical assessments to support deviations and validations;
• Create and execute to project plans and schedules;
• Develop, execute, and review technical documents, validation documents, specifications, development plans, characterization plans, and verification and validation plans
• Provide deep technical assistance for junior engineers.

Why is the Position Open?

Planned project.

Top Must Have

Skills:

• Candidates must have experience and basic qualifications. We are NOT looking for an SME in a specific area but instead an independent experienced leader who can come into a new and upcoming site with a broad spectrum of knowledge and experience to be utilized amongst site teams.
• ** Broad set of expertise
  ** across DS with extensive experience, including:
• Technology Transfer
• Process Scale-up
• Clinical & Commercial Manufacturing Support
• Process Performance Qualification (PPQ)
• CMC Regulatory file drafting and support
• Commissioning and qualification of equipment
• Utilization of process models
• Process characterization, and process optimizations and troubleshooting.
• (Essentially someone at Principal Engineer or Director level in their current role)
• Strong technical and management skills, will need to deliver as an individual and team lead
• Strong collaborations skills, track record of team environment success

Day to Day Responsibilities:

Lead or contribute teams in areas above, delivering the required business result.

Basic Qualifications:

Doctorate degree and 3 years of experience OR Master's degree and 7 years of experience OR Bachelor's degree and 9 years of experience OR Associate's degree and 12 years of experience OR High school diploma / GED and 14 years of experience

Employee Value Proposition:

• Unique industry opportunity
• Career growth

Red Flags:

• Highly specialized in one drug substance (DS) area or no DS experience
• No management experience
• No experience supporting Manufacturing

Interview process:

Phone screen by EWC, Phone interview with hiring manager