About the Role:Serve as the scientific leader for assigned assets, shaping development strategy through deep process understanding and ensuring regulatory defensibility of key decisions. Combines advanced technical expertise with cross-functional influence, guiding asset progression from early development through commercialization. As the primary scientific authority for your programs, define technical direction, lead critical risk assessments, and ensure that scientific rigor guides lifecycle strategy and manufacturing readiness.
Your Contributions (include, but are not limited to):- Apply advanced scientific or engineering principles to complex process development challenges
- Serve as the primary scientific decision-maker for assigned assets
- Lead process scale-up and technology transfer initiatives, proactively managing technical risk
- Plan and manage scientific activities; represent development in cross-functional teams
- Maintain accountability for asset-level deliverables and production planning.
- Lead technical risk assessments to support project advancement
- Independently design and oversee advanced activities supporting clinical through commercial development
- Supervise laboratory and pilot-scale work and ensure safe laboratory practices
- Identify and resolve significant process challenges using data-driven approaches
- Recommend innovative solutions to improve product quality and manufacturing consistency
- Manage contract manufacturing activities and contractor relationships
- Provide scientific leadership in CMC regulatory documentation
- Contribute to development of departmental scientific policies and standards
- Mentor scientists and support professional development
- Build and strengthen internal and external professional relationships
- Perform other duties as assigned
Requirements:- BS/BA in chemistry, biochemistry, biology, or similar scientific discipline OR chemical engineering, biochemical engineering, or similar engineering discipline AND 12+ years of experience in experience in pharmaceutical/process development field, including API manufacturing person in plant activities, Experience managing laboratory, maximizing productivity is desirable. OR
- MS/MA in chemistry, biochemistry, biology, or similar scientific discipline OR chemical engineering, biochemical engineering, or similar engineering discipline AND 10+ years of similar experience noted above OR
- PhD in chemistry, biochemistry, biology or similar scientific discipline OR chemical engineering, biochemical engineering, or similar engineering AND 4+ years of relevant experience; may include postdoc experience
- Broad and deep knowledge of scientific or engineering principles with subject matter expertise
- Recognized authority capable of defending scientific strategy
- Develops creative and effective solutions to technical challenges
- Understands interdependencies across functional areas
- Leads multiple teams or initiatives
- Demonstrates strong leadership and mentoring skills
- Excellent communication and analytical skills
- Understands impact across multiple programs and departments
- Manages multiple priorities with high accuracy
- Strong project management skills
- Thorough understanding of process development and scale-up strategies
- Excellent laboratory and productivity skills
- Knowledge of validation and control strategy development
- Manufacturing experience internally and externally
- Strong understanding of cGMP and regulatory requirements
- Demonstrated cross-functional drug development knowledge
- Advanced proficiency with laboratory equipment and tools
#LI-LS1
The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
