Senior DP Biologics Engineer/Scientist
About The Position
As a Drug Product (DP) Technical Owner (TO) within Global MSAT, you will serve as the end‑to‑end scientific and technical authority for a designated product or portfolio. Acting as the MSAT voice within the Value Chain Team (VCT), you will lead the technical strategy, lifecycle management, and continuous improvement of commercial drug product processes, ensuring sustained compliance, robustness, and supply reliability across internal and external manufacturing networks. The successful candidate will be an integer person with a high level of self-awareness and adaptability. Proven leadership in providing integration of activities and information across multifunctional groups and matrix teams. Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams. Ability to influence peers, superiors, and partners. Understands the technical aspect of the lifecycle strategy of products. Applies the science-based risk approach and regulatory intelligence. Understands culture differences.
Requirements
- A minimum of a bachelor’s degree (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, (biological) Engineering; Life Science Technology) or equivalent required
- Minimum 5 years of progressive experience in sterile/aseptic biologics drug product manufacturing within a GMP-regulated environment, or Process Development/Research or Tech Transfer Experience
- Scientific background in engineering or life sciences (or similar) or experience in the respective field.
- Proven ability to lead and influence cross-functional, matrixed teams across MSAT, Manufacturing, Quality, Regulatory, and Supply Chain with a high degree of autonomy and ownership
- Ability to provide technical leadership for post-approval changes, tech transfers, validation activities, and process improvements
- Deep understanding of GMP, regulatory expectations, and lifecycle management frameworks
- Experience with process performance monitoring and Continued Process Verification (CPV), including data trending, statistical analysis, and identification of improvement opportunities
- Demonstrated ability to apply science-based, risk management tools (e.g., FMEA, risk assessments) to support robust decision-making and regulatory compliance
- Strong business acumen with experience identifying and delivering COGs reduction, process efficiency, and standardization initiatives
- Excellent written and verbal communication skills with the ability to translate complex technical data into clear, actionable insights for senior stakeholders and cross-functional teams
- Advanced proficiency in data analysis, problem-solving, and digital tools (beyond MS Office), with a focus on data-driven decision-making and continuous improvement
- Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
Nice To Haves
- Master’s degree in Science or Engineering preferred
- Proven ability to collaborate and drive outcomes within global, cross-functional, and highly matrixed team environments
Responsibilities
- Represents MSAT and the technical team in the Value Chain Team (VCT) and provides the required manufacturing technical support
- Provide onsite technical support and guidance to CMOs during Tech Transfers and/or Deviation resolutions, representing the MSAT voice
- Serve as the SME and single point of accountability for DP technical aspects across the product lifecycle
- Define and drive the technical lifecycle management strategy, including process robustness, performance monitoring, and continuous improvement
- Supports the VCT to identify improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)
- Owns the coordination of all product-related technical activities
- Monitors technical process and product performance
- Identifies and implements opportunities for active decrease in manufacturing COG’s
- Implements or follows-up on execution of technical projects
- Deploys the platform standardization policy as appropriate
- Supports failure investigations (escalation of quality or compliance events)
- Reviews technical product & process risk profile and criticality analysis
- Implementing and supporting new platforms innovations or changes in life cycle management products
- Provides this expertise as well to External Manufacturing related to the Biotherapeutics Platform
Benefits
- Employee continuous professional development
- Business improvement
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
