About the Role
This role serves as the Technical Lead for the Small Molecule API Chemical Technical Operations Unit, focusing on drug substance tech transfer and commercial manufacture within the North America External Manufacturing Network. It involves managing the technical interface with External Partners, providing process support, evaluating changes, managing risks, and overseeing new product introductions and technical transfers.
Responsibilities
- Operate independently on priorities established with assigned External Partners.
- Foster proactive partnerships with External Partners to meet business goals, identify and mitigate risks, and continuously enhance performance.
- Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.
- Serve as the primary technical contact for assigned External Partners while coordinating with impacted company sites and External Partners.
- Collaborate with internal teams to ensure seamless product supply with an end-to-end mindset.
- Initiate and drive change controls to completion.
- Provide rapid support to External Partners to resolve manufacturing challenges and minimize supply disruptions.
- Collaborate with Research Laboratories groups during New Product Introductions/Tech Transfers and new technology development.
- Provide on-site support at External Partners as required, proactively identifying risks and supporting all phases of execution.
- Conduct technical due diligence assessments and provide expert consultation on chemical manufacturing matters.
- Review process change requests and deviation reports while ensuring regulatory compliance.
- Perform Proactive Process Monitoring to enable robust manufacturing operations & early detection of process issues.
Requirements
- Bachelors in a technical field (Chemical Engineering, Biochemical Engineering, Chemistry, or Pharmaceutical Sciences) with minimum 7 years of relevant pharmaceutical industry experience; or Master’s with minimum 5 years of relevant experience; or PhD with minimum 3 years of relevant experience.
- Experience in manufacturing, specifically in Small Molecule API process production, development, optimization, and tech transfer.
- Ability to travel up to 50%
Skills
- Chemical Manufacturing
- CMO Management
- Communication Management
- Drug Product Manufacturing
- External Manufacturing
- External Partners
- Global Mindset
- Manufacturing Operations
- Manufacturing Processes
- Manufacturing Scale-Up
- Process Monitoring
- Technical Transfer
Location
- North America
Work Type
- Remote
- On-site
Experience Level
- Minimum 7 years of relevant pharmaceutical industry experience (Bachelor's)
- Minimum 5 years of relevant experience (Master's)
- Minimum 3 years of relevant experience (PhD)
Education Level
- Bachelor's in Chemical Engineering, Biochemical Engineering, Chemistry, or Pharmaceutical Sciences
- Master's degree
- PhD
Salary/Compensations
- $142,400.00 - $224,100.00
Benefits
- Medical, dental, vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
- Annual bonus and long-term incentive, if applicable
About the Company
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.
- Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Equal Opportunity
- As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
- As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
- We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
