Remote: Formulation Consultant (236941)

Job Description

This position supports the formulation/product development and manufacturing activities within the Manufacturing Development team of the Technical Operations department.

Responsibilities

• Report directly to project development leader and maintain weekly updates on activities assigned.
• Function as a designated formulation and process expert for product development activities, both internally and externally. Technically review and provide recommendation in a timely manner (2-3 days) on the following documentation, as applicable:
• Development plans and protocols
• QbD assessment
• Stability protocols
• Associated reports
• Data summarization, graphing and trend analysis
• Function as a designated formulation and process expert for scale-up and optimization activities including but not limited to the following tasks:
• Selection and risk management for CDMO (as assigned by project lead)
• DOE studies, process evaluation, IPC and control strategies
• Oversight of manufacturing, summary of observations and optimization during engineering trials
• Collaborate with client team members for bulk clinical manufacturing and filling
• Projection plan for 2025 supplies
• Monitoring of excipient supplies
• Dispensing record and manufacturing batch record review
• Summarize and maintain batch manufacturing summary
• Collaborate with Quality function and CDMO’s to manage and resolve manufacturing deviations / investigations
• Assist in the selection and management of the radiolabeling ADME work stream of the programs, namely
• Vendor selection
• Work plan
• DP development
• Non-gmp manufacturing
• GMP manufacturing
• Shipment logistics
• DP development studies and testing to support API changes
• Polymorph form switch
• API site changes
• API manufacturer switch
• Literature searches (i.e. pediatric application)
• Maintain product documentation and data files in appropriate platforms
• Support regulatory filing needs
• Collaborate with the Supply Chain team to manage shipment of R&D, GLP and GMP supplies/components
• Support selection and finalization of the packaging configuration for the drug products
  

Qualifications

• 10+ (or 8+) years of pharmaceutical formulation development experience with a BS (or MS/PhD) in a scientifically relevant field (Chemical Engineering, Pharmaceutical Engineering, Pharmaceutical Sciences, etc.)
• Technical Subject Matter Expert (SME) in development of pharmaceutical dosage forms (oral solids/liquids and other dosage forms)
• Experience in process development, scale-up and optimization related to gmp manufacturing and packaging of drug products
• High ethical & quality standards and lives them through actions and communication
• Strong computer, organizational, and analytical skills required
• Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders across varied styles and cultures
  
  

Remote: Formulation Consultant (236941)

About Black Diamond Networks

Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.