Sr. Biologics Engineer II, MS&T (Drug Substances)United States - New Jersey - Morris PlainsManufacturing Operations & Supply ChainRegular
- Lead and be hands-on with manufacturing process validations and transfers within internal and external CMOs for Biologics and Anti-body Drug Conjugates (ADCs).
- Represent Manufacturing Sciences and Technology (MS&T) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities relating to clinical and commercial drug substance manufacturing processes, tech transfer, validation, supply/supply chain, quality/ compliance, change management and product life cycle management.
- Participate in cross functional business and scientific initiatives as the MS&T representative, and effectively collaborate and influence cross-functional partners to support MS&T objectives
- Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place through internal/on-site characterization and engineering runs, ensure design spaces (PAR &NOR ranges) are built for critical process parameters for validation and routine manufacturing operations, effective information flow, issue resolution, and documentation in accordance with the expectations of tech transfer quality system.
- Lead the process validation activities ensuring design of validation strategy is in alignment with business needs, regional & global regulatory compliance and support continued process verification post validation
- Review and approve technical documentation including protocols, master batch records, and reports related to engineering, GMP and PPQ runs.
- Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.
- Partnering with product development, manufacturing, quality and regulatory, lead quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place.
- Develop and implement control strategy, identify and implement operational improvements and identify novel technological approaches to and improve product quality attributes and enhance yield.
- Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns.
- Apply manufacturing process lifecycle management principle for establishment and continuous improvement of process control strategy.
- Maintain strong knowledge of GMPs and manage external CMOs.
- Collaborate with process and pharmaceutical development to deliver manufacturing processes that meet the speed, yield and product quality requirements of the development programs.
- Perform critical data review and provide directions for troubleshooting and investigation.
- Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports and author sections of regulatory submissions.
- Perform other duties as required.
Essential Education, Experience & Skills:
- Ph.D. with 0+ years, OR an M.S. with 6+ years, OR a B.S. with 8+ years of pharmaceutical industry experience. (Degrees should be in Biological Sciences, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or relevant field.)
- Experience in managing complex manufacturing execution systems including tech transfer, process characterization, process validation of biological products is highly desirable.
- Process development and operations experience/expertise in drug product manufacturing processes including bulk freeze/thaw, mixing/pooling, filtration, filling and lyophilization.
- General understanding protein structure and its modes of degradation under various processing conditions.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- Excellent and effective verbal and written communication skills.