Director, Process & Analytical Development

Jobtailor

Walkersville (MD)

On-site

USD 180,000 - 270,000

Full time

5 days ago

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Job summary

Jobtailor seeks an accomplished senior leader to direct analytical and process development and project-specific manufacturing within the ADS US organization. You will ensure the ADPD team delivers safe, compliant, on-time results and manages budgets while coaching a high-performing, cross-functional group.

You will drive strategic direction across portfolio management, asset readiness, and continuous improvement, partnering with R&D, Manufacturing, QA, MSAT, and Commercial teams, and oversee

Qualifications

Requires a Master’s degree in a relevant field.
15+ years of progressive leadership in pharma/biotech or CDMO environments.
Deep knowledge of small molecule and bioconjugate tech and GMP operations.
Experience leading Process Development, Analytical Development, and Manufacturing functions.

Responsibilities

Provide leadership for analytical and process development and project-specific manufacturing.
Ensure safe, compliant, on-time, in-full delivery within budget.
Lead, coach, and develop a high-performing ADPD organization.
Define strategic direction via long-term planning, portfolio management, and resource allocation.
Oversee capital investment initiatives and facility startups.

Skills

Leadership

Strategic Planning

Budget Management

Cross-functional

Lean/Six Sigma

Communication

Problem-solving

Decision-making

Education

Master's degree in Engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or related field

Tools

Technology Transfer

Validation

Automation

Data Integrity

Job description

Provide overall leadership for analytical development, process development, and project-specific manufacturing activities within the ADS US organization
Ensure the ADPD organization delivers services and products safely, compliantly, on time, in full, and within budget
Lead, coach, and develop a high-performing ADPD organization
Define and execute strategic direction through long-term planning, portfolio management, resource allocation, organizational design, and performance management
Establish capabilities, infrastructure, and talent for future manufacturing operations and business growth
Contribute to the Sales & Operations Planning (S&OP) process
Oversee development and project-specific manufacturing activities against Safety, Quality, Compliance, Delivery, and Cost expectations
Own organizational budgets, resource planning, and operational performance
Drive Lean maturity, Operational Excellence, and continuous improvement
Lead strategic initiatives and transformation programs
Partner with R&D, Manufacturing, MSAT, Engineering, Quality, Automation, Supply Chain, and Commercial teams
Evaluate, acquire, and implement new technologies
Establish governance processes, performance metrics, and decision-making frameworks
Support site startup, facility expansion, validation, and capital investment initiatives

Requirements

Master’s degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field required
15+ years of progressive leadership experience within pharmaceutical, biotechnology, CDMO, or related life sciences environments
Deep understanding of small molecule and bioconjugate technologies
Extensive leadership experience in Process Development, Analytical Development, Technical Operations, Manufacturing, or related GMP-regulated organizations
Strong understanding of pharmaceutical manufacturing operations, cGMP requirements, technology transfer, validation, operational readiness, and commercialization activities
Experience supporting facility startup, expansion projects, greenfield or brownfield investments, and large-scale capital programs
Proven success leading organizations through growth, transformation, and operational scale-up initiatives
Strong technical knowledge and experience in small molecule drug substance manufacturing
Ability to collaborate across Engineering, Quality, MSAT, Automation, Manufacturing, EHS, HR, Finance, and Commercial functions
Ability to translate business requirements into practical, scalable operational solutions
Strong executive presence and ability to communicate readiness, risks, performance, and recommendations to senior leadership
Experience building organizations, developing talent, and preparing teams for future needs
Understanding of Lean Manufacturing, Six Sigma, Operational Excellence, automation, digital systems, and data integrity principles
Capability in portfolio management, strategic planning, budget ownership, and resource allocation
Ability to navigate ambiguity, manage competing priorities, and lead in a fast-paced environment
Strong leadership, communication, problem-solving, and decision-making skills
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve
Willingness and ability to travel to EMEA and NA approximately 25–30% of the time

Core Competencies

Demonstrates extensive leadership in Process Development, Analytical Development, and Technical Operations within GMP-regulated environments, with a strong focus on operational excellence, strategic planning, and budget management. Capable of driving transformation initiatives and collaborating across multiple functions to achieve business growth and compliance.

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