Manager - Technical Services - Pharmaceutical

Our client – a global and growing BioPharma CDMO company needs a Manager – Technical Services with Pharmaceutical Industry experience at their expanding plant in WA state. Excellent Salary + weekend shift Differential + Annual Bonus. Excellent Benefits (starting day 1) + Generous Relocation Bonus. If needed client will support H1B visa transfer.

Job Posting # 2719

Job Title : Manager – Technical Services - Pharmaceutical Location: Spokane, WA

Relocation: Generous lumpsum bonus for relocation assistance. Weekend Day Shift – See note 2 .

Compensation: Salary range $115K – 175K + Annual Bonus – 10% Target + Shift Differential + 7.5%

Full Benefits (starting Day 1) = Medical, Vision, Dental, 15 days - PTO, 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, lyophilization, packaging of drug products in Vials.

Group Info: Be part of the Plant Technical Services Group of around 20 people. This group supports New Product Introductions from R/D to manufacturing and also existing manufactured products.

Note 1 : This person will have around 5 technical staff reporting to this role working Weekend shift . This role will report to the Assoc Dir of Technical Services.

Note 2 : Weekend Day shift . 10 hours each for 4 days from Fri. – Mon. Shift differential adder pay + 7.5%

Note 3: 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 4: Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Summary:

• The Manager of Technical Services provides oversight and expertise primarily in the areas of pharmaceutical process engineering and technical transfer.
• This position will manage large scale projects and multi-disciplinary teams.
• The Manager will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees.
• The individual will be responsible for refining department and site processes and provide leadership.
• Process Engineers will report directly to Technical Services manager.

Job Description:

• Oversee design, optimization and implementation of site manufacturing processes to improve efficiency, quality and sustainability
• Oversee and assess existing processes and workflows
• Lead team to establish and track process metrics to monitor process stability and discover areas for improvement
• Oversee Technical Transfer of new products from both internal and external clients
• Drive team ownership of product processes from initial quote to product retirement
• Evaluate incoming processes for robustness, efficiency.
• Lead team to perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.
• Review and approve validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.
• Oversee development and execution of validation studies to test and qualify new and improved manufacturing processes.
• Lead team through troubleshooting, oversight and/or sampling of events within Manufacturing; will require occasional off-shift at-location or remote support.
• Review and approve reports summarizing results of studies to document data collected; overview utilization of data obtained to qualify site processes.
• Review and approve protocols, SOPs, reports, deviations requiring Technical Services approval.
• Oversee team review of data summaries generated by other departments, assessment of the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.
• Oversee and participate in or perform deviation investigation and evaluation of impact
• Ensure team implements effective CAPAs
• Provide necessary reviews for regulatory and client audits and provide responses to audit observations
• In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
• Perform all supervisory duties for exempt level Process Engineers. Assign daily work, hiring, performance management, training and other managerial duties.
• Write and manage department SOP’s, training etc. to ensure regulatory compliance and operations enhancement.

Candidate Must Have :

• Bachelor’s Degree in Science (Biology, Chemistry), Engineering or related field.
• 7+ years of Pharma experience with Technical Transfer Services, R/D, MSAT, etc.
• 2+ years of Lead/Managerial experience over a team of Process Engineers
• Project Management experience to lead cross functional teams.
• Ability to work the Weekend shift (see Note 2 above ).

Candidate Nice to Have:

• Master’s or PhD Degree.
• Lean Manufacturing and Statistical Analysis
• Process Validation experience.
• Development, R/D experience
• Experience working in a fast-paced Pharma Contract Manufacturing Organization (CDMO)
• Experience working in aseptic operations - compounding, filling, lyophilization & packaging.

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, Manager, Management, MSAT – Manufacturing Science and Technology