Associate Principal Scientist, Upstream
- Spring House, PA
- As part of our Manufacturing Division, the Biologics Process Development and Commercialization department provides the Drug Substance technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, this department leads various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, including but not limited to mAbs, the scope includes deep manufacturing sciences & technology support, process enhancements, next generation process (i.e., post approval) development and implementation.
- Under the general scientific and administrative direction of the Director in Upstream and working in conjunction with internal and external partners, this individual will support these late stage commercialization and commercial biologics program activities within the Upstream Process Development team. The individual will demonstrate scientific, experimental and tech transfer skills focusing on upstream processing.
- Participates in teams focusing on late stage process development, characterization, and validation with line-of-sight for licensure and commercialization.
- Provides technical leadership for technology transfer, process validation/PPQ, facility fit, risk assessments, manufacturing campaigns, process and plant modeling, regulatory filings (IND/BLA/PAS) and post approval life cycle management
- Responsible for laboratory-scale and manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations including studies performed either in-house or externally.
- Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., SPC/MVA) and for further technical investigations.
- Primary focus will be on drug substance upstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including downstream, analytical and drug product process.
- Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams and leads technical teams through matrix and direct management structures.
- Leadership in workforce planning, talent development and people management
Position Qualifications :
Education Minimum Requirement:
- BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 10 years (for BS) or 8 years (for MS) relevant experience. PhD candidates with 4+ year(s) of relevant experience will also be considered.
Required Experience and Skills**:
- Technical expertise (Process Sciences and Engineering) in cell culture for biological molecules from mammalian-based expression systems
- Experience with process characterization, technology transfer, facility fit assessments, commercial control strategy, process validation/PPQ, manufacturing site readiness and regulatory submissions (IND, BLA, PAS).
- Direct experience working with internal and external contract manufacturing organizations. Working understanding of biologics characterization and US/EU regulatory requirements
- Technical operations experience in the manufacture of biological molecules at the pilot- and commercial-scale.
- Excellent oral and written communication skills. Prior matrix and/or people management.
Preferred Experience and Skills:
- Experience with drug substance processing of biological molecules, with an in-depth knowledge of aspects of the process sciences (e.g., cell culture) and engineering.
- Demonstrated understanding of the fundamentals and modeling of drug substance unit operations.
- Prior experience with PAI, regulatory inspections and working knowledge of cGMPs.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
- Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are ...
We are known as Our Company Inc., Kenilworth, New Jersey, USA in the United States and Canada and Our Company everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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