Assoc. Director - Technical Services - Pharmaceutical

MRINetwork Jobs; Spokane (WA); On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Relocation bonus

Full benefits

Job summary

MRINetwork Jobs is representing a global BioPharma CDMO in Spokane, WA, seeking an Associate Director – Technical Services with extensive pharmaceutical industry experience. The role oversees a 20-person technical staff and reports to the Director of Technical Services.

A relocation bonus and full benefits are offered, with a competitive salary and 15% target bonus. The position requires a Bachelor's degree in Science or Engineering, 10+ years in technical transfer/R&D, and 3+ years of

Qualifications

• 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

Responsibilities

• Transfer technology for new products from development to manufacturing sites.
• Transfer technology to Manufacturing during process validation of products.
• Plan and manage developmental and transfer activities including ScaleUp and batch validation.
• Provide technical support to manufacturing by reviewing SOPs, Protocols, and reports.
• Supervise exempt scientists and hourly technicians, assign work and coach staff.
• Write and manage department SOPs, training, and ensure regulatory compliance.
• Coordinate investigation and closure of incidents.
• Coordinate media fills and related SOPs.

Skills

Technical Transfer

Leadership

Regulatory compliance

Process validation

GMP

Education

Bachelor's degree in Science/Engineering

Job description

Job Description

Job Description

Our client – a global and growing BioPharma 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.

Job Posting # 2699

Job Title: Assoc. Director – Technical Services - Pharmaceutical

Location: Spokane, WA

Relocation: The client offers a generous lumpsum bonus for relo assistance.

Compensation: Annual salary range of $150K – 180K + Annual Bonus – 15% Target

Full Benefits = Medical, Vision, Dental, 15 days’ vacation/sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

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.

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

Note 1: 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. Note 2: 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.

Note 3: Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Description:

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, ScaleUp, 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

Candidate Must Have:

• 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

Candidate Nice to Have:

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

Keywords: 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