Assoc. Director - Technical Services - Pharmaceutical

Our client - a global and growing Bio Pharma CDMO company needs an Associate Director - Technical Services with Pharmaceutical Industry experience at their expanding plant in WA state, Excellent total comp.
up to $200K+ with excellent Benefits + Relocation Bonus
.

Assoc. Director - Technical Services - Pharmaceutical

Spokane, WA

The client offers a generous lump-sum bonus for relocation assistance.

Annual salary range of $150K - 180K + Annual Bonus - 15% Target

Medical, Vision, Dental, 15 days vacation/sick time, 10 Holidays, 401k (match up to 4%)

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries. This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Be part of the Plant Technical Services Group
. This group supports New Product Introductions from R/D to manufacturing and also existing manufactured products.

This person will have around 20 technical staff working Weekday/Weekend shifts including 2 managers reporting to this role. This role will report to the Dir of Technical Services.

The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site.

Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

The Associate Director of Technical Services is responsible for providing technical expertise to develop, validate, and enhance manufacturing processes.

• Transfer technology for new products from the development site(s) to the manufacturing site
• Transfer technology to Manufacturing during the process validation of submitted/approved products
• Plan and manage successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit/Registration for ANDA submission, component changes and process validation batches.
• Provide technical support to manufacturing (i.e. review SOPs, Protocols, reports, etc.)
• Perform all supervisory duties including for exempt level scientists and hourly technicians. Assigning daily work, hiring, performance management, training and other managerial duties.
• Write and manage department SOPs, training, etc. to ensure regulatory compliance and operations enhancement.
• Coordinate investigation and closure of incidents.
• Coordinate media fills and related SOPs

• Bachelor's Degree in Science, Engineering or related field.
• 10+ years of related technical experience with Technical Transfer Services, R/D etc.
• 3+ years of Managerial experience over a team of 10+
• Pharmaceutical and FDA Regulated Industry experience
• Experience with sterile / aseptic liquid filling and packaging

• Master Degree.
• Experience working in a fast-paced Pharma Contract Manufacturing Organization (CDMO)
• Experience working in aseptic filling, Formulations & Compounding operations.

Process engineering, Technical transfer, Project, Manufacturing support, Pharma, CDMO, plant, FDA, GMP, Sterile Aseptic liquid filling, contract Manufacturing, Lean Mfr, CAPA, Change control, NPI, Director, Management