Engineer Associate Director Start-Lead New Drug Substance Facility (

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