Archived listing. The details below describe a past opening.
JOB SUMMARY
The Associate Director of Process Technical Services provides technical and operational leadership for the development, optimization, and scale-up of active pharmaceutical ingredient (API) processes from laboratory through commercial manufacturing. This role leads scientific teams, executes departmental strategies, establishes operational priorities, and oversees resource allocation to ensure successful program delivery. Provides technical guidance to resolve complex challenges, mitigate risks, and ensure regulatory compliance. Partners cross-functionally with Project Management, Business Development, Manufacturing, and Quality to align departmental activities with organizational objectives, drive continuous improvement, and support operational excellence.
DUTIES AND RESPONSIBILITIES
- Direct the operational activities of the Process Technical Services function, leading and developing scientific teams responsible for API process development, optimization, and scale-up from laboratory through commercial manufacturing.
- Develop and execute departmental operational plans and technical strategies to support API process development, manufacturing readiness, and organizational business objectives.
- Oversee departmental resource planning, workload prioritization, and allocation of scientific personnel to ensure effective execution of development and manufacturing support activities across multiple programs.
- Provide department-level technical leadership and decision-making for complex API process development, scale-up, and manufacturing challenges, applying expertise in process chemistry to evaluate technical risks and direct appropriate mitigation strategies.
- Ensure departmental activities comply with applicable safety standards, regulatory requirements, quality expectations, and contractual obligations.
- Partner cross-functionally with Research & Development, Manufacturing, Quality, Project Management, Business Development, and other functional organizations to coordinate technical activities, resolve operational challenges, and support successful program execution and product pipeline development.
- Oversee the planning and coordination of technical development and production support activities to ensure project milestones, schedules, and deliverables are achieved.
- Identify, assess, and mitigate technical and operational risks across assigned programs, implementing proactive strategies to minimize disruptions and support successful outcomes.
- Lead departmental continuous improvement initiatives, establish and standardize technical processes and best practices, and collaborate with Manufacturing, Quality, and Project Management to improve process robustness, operational efficiency, and technology transfer outcomes.
- Monitor departmental performance, project progress, technical risks, and resource requirements; provide regular updates, recommendations, and operational insights to department leadership and support senior leadership communications as appropriate.
- Adhere to all company SHE policies and procedures, actively participate in hazard identification and environmental risk reduction, and report all incidents, nonconformities, and potential hazards to management to support a safe, healthy, and environmentally responsible workplace.
- May perform other duties as assigned.
EDUCATION AND EXPERIENCE
- Typically requires 8 years of experience in the related area and a bachelor's degree or equivalent experience. Managerial experience required; 3+ years of managerial experience preferred.
- Ph.D. or B.S./M.S. with significant experience.
- 5-10 years of pharmaceutical or directly related experience in appropriate discipline/science.
COMPETENCIES/SKILLS
- Must be highly detail oriented and have strong technical and organizational ability.
- Ability to interpret regulations, standards and guidance, relevant procedures and implement requirements.
- Must have excellent written and verbal communication skills.
- Must be able to work collaboratively in a team environment.
CERTIFICATION/LICENSES
WORKING CONDITIONS
Participates in production support including nights, weekends, and holidays. This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.