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Associate Director, Technical Services
Cosette Pharmaceuticals, Inc.. Lead end-to-end technology transfer activities for acquired products, new or alternate manufacturing sites, packaging sites, and other product transfers .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading technology transfer activities, process validation, and lifecycle management within the pharmaceutical industry. Possesses strong knowledge of cGMP compliance, regulatory requirements, and cross-functional collaboration to drive successful product transfers and manufacturing readiness.
Highest-signal resume keywords
Technology Transfer LeadershipProcess Validation ExpertiseRegulatory Compliance KnowledgeCross-Functional CollaborationPharmaceutical Manufacturing Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technology TransferProcess ValidationLifecycle ManagementCGMP ComplianceAnalytical MethodsChange ControlCAPAManufacturing ProcessesRisk AssessmentValidation Approaches
Soft Skills
Strategic ThinkingData-Driven Decision MakingCross-Functional LeadershipExecutive-Level CommunicationSolution-Oriented Problem Solving
Industry Keywords
Pharmaceutical SciencesChemical EngineeringCommercial ManufacturingCMOsCDMOsCPOsFDA Regulatory ExpectationsStability StudiesTechnical GovernanceProduct Lifecycle
About the role
Key responsibilities & impact- Lead end-to-end technology transfer activities for acquired products, new or alternate manufacturing sites, packaging sites, and other product transfers
- Establish transfer strategies, technical requirements, risk assessments, validation approaches, acceptance criteria, project milestones, and readiness expectations
- Coordinate formulation/process knowledge, equipment capability, raw materials, packaging components, validation, stability, regulatory requirements, and manufacturing readiness
- Provide scientific and technical leadership for Cosette's commercial portfolio and serve as a primary escalation point for complex manufacturing, packaging, and product-performance issues
- Lead technical assessment and implementation of lifecycle changes affecting approved products
- Provide technical leadership for complex deviations, investigations, OOS/OOT events, manufacturing failures, recurring process issues, and product complaints
- Serve as a senior technical interface with Cosette's CMO/CPO network and establish technical governance with external manufacturing partners
- Provide technical leadership for process validation, packaging validation, hold-time studies, cleaning-validation technical assessments, and continued process verification
- Evaluate new or alternate API manufacturers, CMOs, CPOs, critical component suppliers, and manufacturing technologies
- Identify and mitigate technical risks involving materials, equipment, processes, CMOs, technology transfers, and product lifecycle
- Partner with Regulatory Affairs and Quality on regulatory impact, technical documentation, cGMP compliance, and quality-system execution
- Support supply continuity with Operations and Supply Chain
- Maintain the integrated Technical Services portfolio and manage priorities, milestones, risks, resources, budget, and forecasts
- Support technical due diligence for potential product and company acquisitions
- Lead or support technical integration and transfer activities following acquisitions
- Report directly to the Vice President Technical Services and 3rd Party Operation and partner cross-functionally across Scientific Affairs, Analytical, Regulatory Affairs, Quality, Operations, Supply Chain, Alliance Management, Strategic Sourcing, and external manufacturing partners
Requirements
What you’ll need- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmacy, or a related scientific/engineering discipline required
- Master's degree, PharmD, or PhD preferred
- Approximately 12+ years of progressive pharmaceutical industry experience
- Substantial experience supporting commercial manufacturing, technology transfer, process validation, lifecycle management, and external manufacturing
- Experience working with CMOs/CDMOs/CPOs and leading complex technical programs across multiple products and manufacturing sites
- Experience with branded and/or complex pharmaceutical products and post-approval lifecycle management strongly preferred
- Strong knowledge of pharmaceutical manufacturing, scale-up, process validation, cGMP, investigations, change control, CAPA, stability, CMC, analytical methods, manufacturing/packaging processes, and FDA regulatory expectations
- Strategic and scientific thinking
- Strong business acumen
- Timely, data-driven decision making and effective technical risk management
- Cross-functional leadership and influence
- Executive-level communication of complex technical risks, recommendations, and decisions
- People leadership, coaching, succession planning, and development of technical talent
- High ownership, accountability, transparency, and solution-oriented problem solving
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability
- Long-term disability
- 401(k) match
- Flexible spending accounts
- Health savings account
- Employee assistance program
- Tuition reimbursement program
- Parental leave
- Wellness program
- Paid time off
- Volunteer time
- Holidays